Horizon Pharma Announces First Quarter 2012 Financial Results
Encouraging Initial DUEXIS(R) Launch Metrics Conference Call and Webcast Today, May 10th, at 8:00 a.m. ET
(firmenpresse) - DEERFIELD, IL -- (Marketwire) -- 05/10/12 -- Horizon Pharma, Inc. (NASDAQ: HZNP) today provided an update on the Company's business and announced financial results for the first quarter ended March 31, 2012.
DUEXIS, the Company's proprietary single-tablet combination of ibuprofen and famotidine, was launched in December 2011 with sampling and initial physician detailing, and fully launched in January 2012 following the Company's national sales launch meeting.
Initial feedback from physicians, managed care access and initial prescription growth are encouraging and building momentum.
Total DUEXIS revenues recognized in the quarter ended March 31, 2012, were $1.1 million, with trade discounts and allowances of $0.05 million and co-pay assistance costs of $0.15 million resulting in net revenues recognized of $0.9 million.
Total prescriptions for January, February and March grew by 115%, 77% and 51%, respectively, compared to the prior month.
Approximately 2,700 physicians have prescribed DUEXIS since launch.
Expansion of the Company's field sales force from 80 representatives currently to approximately 160 representatives underway with completion expected in second half of 2012.
RAYOS (modified release prednisone), the Company's proprietary product candidate for the treatment of rheumatoid arthritis, has an FDA PDUFA (Prescription Drug User Fee Act) goal date of July 26, 2012.
Completed $60.0 million senior secured loan facility in February 2012, which provided the Company with net proceeds of approximately $34.0 million, after repaying outstanding amounts under previous debt facilities.
Completed $50.8 million private placement of common stock and warrants to purchase common stock in March 2012 raising net proceeds of approximately $47.6 million.
Amended the DUEXIS regulatory filing in Europe by withdrawing and updating to include recently approved manufacturing site.
Announced exclusive agreement for distribution of LODOTRA® in Latin America by Mundipharma.
"The first quarter of 2012 has been a very busy and exciting time for us," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma. "We followed up our commercial launch of DUEXIS in December of last year with our national launch meeting in late January. We are encouraged by early feedback from physicians, managed care access and initial prescription growth. We also completed a $60.0 million debt financing in February 2012 and a $50.8 million private equity offering in March 2012 providing us with additional capital to fund the ongoing commercial launch of DUEXIS in the U.S. and to pursue regulatory approval for RAYOS in the U.S. and DUEXIS in Europe."
Decision on RAYOS New Drug Application by FDA by July 26, 2012 PDUFA goal date.
Potential launch of RAYOS in the U.S. market in the second half of 2012, assuming FDA approval by July 26, 2012.
Anticipated decision on updated marketing authorization application (MAA) for DUEXIS by European regulatory authorities in second half of 2012.
In December 2011, the Company began recognizing revenues from the sale of DUEXIS following its commercial launch in the U.S. DUEXIS is currently sold to wholesale pharmaceutical distributors and to several national and regional retail chains. Until the Company can reliably estimate returns, the Company has determined that shipment of products to wholesale distributors and retail chains does not meet the criteria for revenue recognition at the time of shipment. The Company is currently deferring DUEXIS revenue recognition from sales to wholesale distributors and retail chains until the right of return no longer exists, which is the earlier of DUEXIS being dispensed through patient prescriptions or the expiration of the right of return.
Total DUEXIS revenues recognized in the quarter ended March 31, 2012, were $1.1 million, with trade discounts and allowances of $0.05 million and co-pay assistance costs of $0.15 million resulting in net revenues recognized of $0.9 million. As of March 31, 2012, the Company had $1.4 million in deferred revenue on its balance sheet related to DUEXIS shipments.
For the first quarter ended March 31, 2012, gross and net sales were $2.7 million and $2.5 million, respectively, compared to $1.8 million in gross and net sales for the first quarter of 2011. This represented an increase of 52% and 41% in gross and net sales, respectively, for the first quarter of 2012 compared to the prior year. DUEXIS, the Company's proprietary single-tablet combination of ibuprofen (800 mg) and famotidine (26.6 mg), which was launched in the U.S. market in December 2011, represented 42% of total sales and 37% of net sales during the quarter ended March 31, 2012. Net loss for the first quarter ended March 31, 2012, was $23.7 million, or $0.98 per share, compared to a net loss of $7.7 million, or $5.13 per share in the quarter ended March 31, 2011. Non-GAAP net loss for the quarter ended March 31, 2012, was $20.5 million, or $0.85 per share, compared to non-GAAP net loss of $6.0 million, or $4.04 per share in the first quarter of 2011. Horizon provides non-GAAP financial measures, which it believes can enhance an overall understanding of Horizon's financial performance when considered together with GAAP figures. Refer to the section of this press release below entitled for a full discussion on this subjectThe Company had cash and cash equivalents of $80.4 million at March 31, 2012, after completing debt and equity transactions during the quarter.
Research and development expenses increased $1.3 million, or 49%, from $2.7 million during the three months ended March 31, 2011, to $4.1 million during the three months ended March 31, 2012. The increase in research and development expenses was primarily due to an increase in salaries and benefits related expenses as a result of an increase in personnel, an increase in clinical research expenses in support of our RAYOS New Drug Application submission and on-going clinical expenses associated with DUEXIS clinical studies.
Sales and marketing expenses increased $9.9 million, from $1.1 million during the three months ended March 31, 2011, to $11.0 million during the three months ended March 31, 2012, which was primarily attributable to staffing our sales and marketing functions during the fourth quarter of 2011, increased marketing and promotional efforts, increased advertising expenses and higher samples and market research expenses in support of our product launch of DUEXIS in the first quarter of 2012.
General and administrative expenses increased $2.1 million, from $3.1 million during the three months ended March 31, 2011, to $5.2 million during the three months ended March 31, 2012. The increase in general and administrative expenses was primarily due to higher legal and consulting expenses associated with ongoing commercial development activities, public company compliance activities and intellectual property related matters. In addition, salaries and benefits expense were higher due to an increase in administrative personnel as compared to the prior year.
Interest expense, net increased $3.3 million, from $1.3 million during the three months ended March 31, 2011, to $4.6 million during the three months ended March 31, 2012. The increase in interest expense was primarily attributable to the Oxford and Kreos debt extinguishment in February 2012, which required the Company to pay both a pre-payment penalty and an end of loan payment.
Foreign exchange gain increased $0.1 million, from $0.4 million during the three months ended March 31, 2011, to $0.5 million during the three months ended March 31, 2012. The increase in the current year foreign exchange gain was primarily due to an increase in non-Euro denominated transactions for the Company's subsidiary, Horizon Pharma AG, in addition to a strengthening of the Euro during the three months ended March 31, 2012.
Net loss for the first quarter of 2012 was $23.7 million, or $0.98 per share, compared to a net loss of $7.7 million, or $5.13 per share, in the first quarter of 2011. On a non-GAAP basis, after excluding certain non-cash expenses, net loss for the first quarter of 2012 was $20.5 million, or $0.85 per share, compared to a net loss of $6.0 million, or $4.04 per share, for the first quarter of 2011.
Horizon provides non-GAAP net income (loss) and net income (loss) per share financial measures that include adjustments to GAAP figures. These adjustments to GAAP exclude non-cash items such as stock-based compensation and depreciation and amortization, and other non-cash charges. 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 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 for a reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures.
At 8:00am Eastern Time today, Horizon's management will host a live conference call and webcast to review the Company's 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 74783564. Telephone replay will be available approximately two hours after the call. To access the replay, please call 1-800-585-8367 (U.S.) or 404-537-3406 (international). The conference ID number for the replay is 74783564.
Horizon Pharma, Inc. is a biopharmaceutical company that is developing and commercializing innovative medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases. For more information, please visit .
This press release contains forward-looking statements, including statements regarding the on-going commercial launch of DUEXIS, the planned expansion of the Company's field sales force, the pursuit of regulatory approval for RAYOS in the U.S. and DUEXIS in Europe, the expected timelines for regulatory approvals and potential commercial launches. 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, whether initial commercial data regarding DUEXIS in the United States are indicative of future results, Horizon's ability to successfully recruit and retain additional sales and marketing personnel or to successfully manage contract sales and marketing personnel, whether RAYOS and/or DUEXIS will be approved for marketing in the U.S. and Europe, respectively, the potential for delays in regulatory review of Horizon's applications for marketing approval, and Horizon's ability to comply with any post-approval regulatory requirements. 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 J. De Vaere
Executive Vice President and Chief Financial Officer
Investors
Kathy Galante
Burns McClellan, Inc.
212-213-0006
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Datum: 10.05.2012 - 05:00 Uhr
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