Horizon Pharma plc Reports Third Quarter 2014 Financial Results and Raises Guidance for 2014 and 2015
Net Sales Increase Three-Fold to $75.1 Million; Adjusted EBITDA of $28.1 Million; Conference Call and Webcast Today, November 6th, at 8:00 a.m. ET
(firmenpresse) - DUBLIN, IRELAND -- (Marketwired) -- 11/06/14 -- (NASDAQ: HZNP) today provided an update on the Company''s business and announced financial results for the third quarter and nine months ended September 30, 2014.
"Our strong operational execution in the third quarter, along with our recent business development activity, gives us great confidence as we close out this year," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc. "Our year-to-date performance, along with expectations for ACTIMMUNE® and our recently announced acquisition of PENNSAID® 2%, allow us to increase our guidance for both 2014 and 2015."
Total net sales in the third quarter of 2014 were $75.1 million, compared with $24.1 million in the third quarter of 2013, representing 211.6 percent year over year growth.
Gross profit margins were 81.8 percent of net sales in the third quarter of 2014 compared with 86.7 percent of net sales in the third quarter of 2013, and on a non-GAAP basis, were 95.7 percent of net sales in the third quarter of 2014 compared with 92.7 percent of net sales in the third quarter of 2013, after excluding depreciation, intangible amortization, amortization of inventory step-up and royalty accretion.
Total operating expenses were $73.5 million in the third quarter of 2014, compared to $23.6 million in the third quarter of 2013. Third quarter 2014 operating expenses included $28.3 million of Vidara transaction expenses.
Adjusted EBITDA was $28.1 million after excluding the impact of $31.5 million in Vidara acquisition related expenses, a bargain purchase gain from the Vidara acquisition of $22.2 million and other non-GAAP adjustments, compared with $0.6 million in the previous year.
On a GAAP basis, net income in the third quarter of 2014 was $2.1 million, or $0.03 basic earnings per share and $0.02 diluted earnings per share.
Adjusted non-GAAP net income was $25.3 million, or $0.32 basic earnings per share and $0.24 diluted earnings per share.
The Company had cash and cash equivalents of $248.8 million as of September 30, 2014, an increase of $119.9 million from June 30, 2014, including approximately $81.8 million remaining from the proceeds of the $300 million senior secured credit facility after the cash payment for the Vidara transaction and financing expenses.
Total debt was $413.8 million, with net debt at $165.0 million at September 30, 2014. These figures do not take into account the conversion of $69.4 million of the 5% Convertible Senior Notes that occurred in late October 2014.
On September 19, 2014, the Company completed the acquisition of Vidara Therapeutics International plc and the resulting formation of Horizon Pharma plc, headquartered in Dublin, Ireland.
Elected Liam Daniel and Virinder Nohria, M.D., Ph.D. to the Company''s board of directors following the closing of the acquisition of Vidara Therapeutics International plc.
Received FDA approval of Orphan Drug Designation for ACTIMMUNE in Friedreich''s ataxia (FA).
Presented encouraging data from a Phase 2 clinical study of ACTIMMUNE (interferon gamma-1b) treatment in children with FA.
Acquired the U.S. rights to PENNSAID 2% on October 17, 2014 for a $45 million one-time cash payment along with an eight-year exclusive manufacturing agreement and announced expectation to begin selling the product in early January 2015.
Received three additional patents from the U.S. Patent and Trademark Office with claims covering VIMOVO with patent terms through 2022.
Received a Notice of Allowance from the U.S. Patent and Trademark Office on a patent application covering VIMOVO and titled "Method for Treating a Patient at Risk for Developing an NSAID-associated Ulcer" with expected patent terms out to 2030.
Received additional Notice of Allowance from the U.S. Patent and Trademark Office with claims covering RAYOS out to 2027.
Induced conversion of an aggregate principal amount of $69.4 million of 5.00% Convertible Senior Notes due 2018, issuing an aggregate of 12,944,350 ordinary shares and making an aggregate cash payment of $14.6 million in late October 2014.
Based on current business expectations, along with the recently completed acquisition of PENNSAID 2%, the Company today updated and raised its guidance for both 2014 and 2015:
In summary, Mr. Walbert said, "We are excited about our long term prospects as we continue to focus on making our products more accessible to patients in the U.S. through our Prescriptions Made Easy™ program. Our strong operating cash flow and financial leverage support our ability to execute on our aggressive business development strategy to acquire products and companies to further enhance shareholder value."
Horizon provides certain financial measures such as adjusted non-GAAP net income (loss), adjusted non-GAAP net income (loss) per share, non-GAAP gross profit margins and non-GAAP cash from operations that include adjustments to GAAP figures. These adjustments to GAAP exclude the bargain purchase gain related to the acquisition of Vidara, acquisition transaction related expenses as well as non-cash items such as stock compensation, depreciation and amortization, royalty accretion, non-cash interest expense, and other non-cash adjustments such as the increase or decrease in the fair value of the embedded derivative associated with the Company''s convertible senior notes. 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. EBITDA, or earnings before interest, taxes, depreciation and amortization, and adjusted EBITDA are also used and provided by Horizon as non-GAAP financial measures. 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 operational 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. Please refer to the financial statements portion of this press release where the Company has provided a reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures. However, the Company has not provided a reconciliation of full year 2014 and 2015 adjusted EBITDA outlook to a net income (loss) outlook because certain items that are a component of net income (loss) but not part of adjusted EBITDA, such as stock compensation and acquisition related expenses, cannot be reasonably projected, either due to the significant impact of changes in Horizon''s stock price on stock compensation, or the variability associated with acquisition related expenses due to timing and other factors.
At 8:00 a.m. Eastern Time today, the Company will host a live conference call and webcast to review its financial and operating results and provide a general business update.
The live webcast and a replay may be accessed by visiting Horizon''s website at . Please connect to the Company''s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call 1-888-338-8373 (U.S.) or 973-872-3000 (international) to listen to the conference call. The conference ID number for the live call is 21893017. Telephone replay will be available approximately two hours after the call and until November 13. To access the replay, please call 1-855-859-2056 (U.S.) or 404-537-3406 (international). The conference ID number for the replay is 21893017.
Horizon Pharma plc is a specialty biopharmaceutical company focused on improving patients'' lives by identifying, developing, acquiring and commercializing differentiated products that address unmet medical needs. The Company markets a portfolio of products in arthritis, inflammation and orphan diseases. Horizon''s U.S. marketed products are ACTIMMUNE® (interferon gamma-1b), DUEXIS® (ibuprofen/famotidine), RAYOS® (prednisone) delayed-release tablets and VIMOVO® (naproxen/esomeprazole). Beginning in January 2015, the Company expects to begin marketing PENNSAID® (diclofenac sodium topical solution) 2% w/w in the United States. Horizon''s global headquarters are in Dublin, Ireland. For more information, please visit .
This press release contains forward-looking statements, including statements regarding expected 2014 and 2015 net revenue and adjusted EBITDA, the expected timing for commencement of commercialization of PENNSAID 2%, Horizon''s growth strategy and the on-going commercialization of ACTIMMUNE, DUEXIS, RAYOS and VIMOVO. These forward-looking statements are based on management''s expectations and assumptions as of the date of this press release, and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include, but are not limited to, risks regarding Horizon''s ability to commercialize products successfully, including risks relating to availability of coverage and adequate reimbursement and pricing from government and third party payers and risks relating to the success of Horizon''s Prescriptions-Made-Easy or PME specialty pharmacy program, whether commercial data regarding ACTIMMUNE, DUEXIS, PENNSAID 2%, RAYOS and VIMOVO in the United States for any historical periods are indicative of future results, Horizon''s ability to comply with post-approval regulatory requirements, Horizon''s ability to enforce its intellectual property rights to its products, and Horizon''s ability to execute on its plan to grow through acquiring or in licensing additional products or companies. For a further description of these and other risks facing the Company, please see the risk factors described in the Company''s filings with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in those filings. Forward-looking statements speak only as of the date of this press release and the Company undertakes no obligation to update or revise these statements, except as may be required by law.
Robert F. Carey
Executive Vice President, Chief Business Officer
Elizabeth M. Higashi, CFA
Vice President, Investor Relations
+1 224 383-3285
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Datum: 06.11.2014 - 06:00 Uhr
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