SOURCE: Horizon Pharma plc

Horizon Pharma plc

November 09, 2015 07:00 ET

Horizon Pharma plc Announces 2016 Net Sales and Adjusted EBITDA Guidance; Reviews 2020 Long-Range Plan

DUBLIN, IRELAND--(Marketwired - Nov 9, 2015) -

  • Full-Year 2016 Net Sales Guidance of $950 to $975 million 
  • Full-Year 2016 Adjusted EBITDA Guidance of $460 to $475 million 
  • 2020 Long-Range Plan Net Sales Estimated to Exceed $2 billion 
  • Long-Range Plan Estimates Orphan Business to Represent Approximately 60 percent of Net Sales in 2020 

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 at

"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.
  • 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.

About Horizon Pharma plc
Horizon Pharma plc is a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs. The Company markets seven medicines through its orphan, primary care and specialty business units. Horizon's global headquarters are in Dublin, Ireland. For more information, please visit Follow @HZNPplc on Twitter or view careers on our LinkedIn page.

Note Regarding Use of Non-GAAP Financial Measures
EBITDA, or earnings before interest, taxes, depreciation and amortization, and adjusted EBITDA are used and provided by Horizon as non-GAAP financial measures. Adjustments to EBITDA exclude acquisition transaction related expenses, loss on debt extinguishment, as well as non-cash items such as share-based compensation, depreciation and amortization, royalty accretion, non-cash interest expense, and other non-cash adjustments. Certain other special items or substantive events may also be included in the non-GAAP adjustments periodically when their magnitude is significant within the periods incurred. Horizon believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Horizon's financial performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of the company's expected 2015, 2016 and 2020 financial results and trends. In addition, these non-GAAP financial measures are among the indicators Horizon's management uses for planning and forecasting purposes and measuring the Company's performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. Horizon has not provided reconciliation of an expected adjusted EBITDA outlook to an expected net income (loss) outlook because certain items that are a component of net income (loss) cannot be reasonably projected, either due to the significant impact of changes in Horizon's stock price on share-based compensation, the variability associated with acquisition related expenses due to timing and other factors.

Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to Horizon's expected full-year 2015 and 2016 net sales and adjusted EBITDA guidance, long-range plan net sales, adjusted EBITDA margin and product mix in 2020, expected financial performance in future periods, expected timing of clinical and regulatory events, Horizon Pharma's business strategy and plans, potential future indications for Horizon Pharma's existing products 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 full-year 2015, 2016 or 2020 financial and operating results may differ from its expectations; Horizon Pharma's ability to grow net sales from existing products, successfully acquire additional products and increase the portion of net sales from its orphan business unit relative to its other business units; the availability of coverage and adequate reimbursement and pricing from government and third-party payors and risks relating to the success of Horizon's patient support program; risks associated with clinical development and regulatory approvals; 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 Pharma operates and those risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in Horizon's filings and reports with the U.S. Securities and Exchange Commission ("SEC"). Horizon Pharma undertakes no duty or obligation to update any forward-looking statements contained in this presentation as a result of new information.

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