DUBLIN, Feb. 23, 2016 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the full year and the fourth quarter of 2015 and provided financial guidance for 2016.
“In 2015, we delivered solid growth on the top- and bottom-line while increasing investment in new growth opportunities for our current products and our promising R&D pipeline,” said Bruce C. Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals plc. “We look forward to 2016 as we focus on delivering growth of our key commercial products, preparing for our planned launch of defibrotide in the U.S., reaching important clinical milestones, including completing enrollment and determining preliminary results of our JZP-110 Phase 3 safety and efficacy studies, and potentially expanding our commercial and development portfolio through corporate development activities.”
Adjusted net income attributable to Jazz Pharmaceuticals plc for 2015 was $600.1 million, or $9.52 per diluted share, compared to $520.5 million, or $8.31 per diluted share, for 2014. Adjusted net income attributable to Jazz Pharmaceuticals plc for the fourth quarter of 2015 was $163.5 million, or $2.60 per diluted share, compared to $151.1 million, or $2.40 per diluted share, for the fourth quarter of 2014.
GAAP net income attributable to Jazz Pharmaceuticals plc for 2015 was $329.5 million, or $5.23 per diluted share, compared to $58.4 million, or $0.93 per diluted share, for 2014. GAAP net income attributable to Jazz Pharmaceuticals plc for the fourth quarter of 2015 was $82.8 million, or $1.32 per diluted share, compared to $81.6 million, or $1.30 per diluted share, for the fourth quarter of 2014. Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included in this press release.
2015 Revenues and Product Sales
Total revenues for the year ended December 31, 2015 were $1,324.8 million, an increase of 13% over total revenues of $1,172.9 million for the year ended December 31, 2014. Total revenues for the fourth quarter of 2015 were $340.9 million, an increase of 4% over total revenues of $328.1 million for the fourth quarter of 2014. The increase in total revenues was driven by higher net product sales of Xyrem® (sodium oxybate) oral solution. Total revenues include net product sales, royalties and contract revenues.
Net product sales for 2015 and the fourth quarter of 2015 were as follows:
- Xyrem: 2015 Xyrem net sales increased by 23% to $955.2 million compared to $778.6 million during the prior year. Xyrem net sales increased by 13% to $251.8 million in the fourth quarter of 2015 compared to $222.5 million in the fourth quarter of 2014.
- Erwinaze®/Erwinase® (asparaginase Erwinia chrysanthemi): 2015 Erwinaze/Erwinase net sales were $203.3 million compared to $199.7 million during the prior year. Erwinaze/Erwinase net sales were $50.4 million in the fourth quarter of 2015 compared to $52.8 million in the fourth quarter of 2014. Product sales volume for the full year and fourth quarter of 2015 increased compared to the same periods in 2014; however, net sales were negatively impacted by higher chargebacks and rebates and unfavorable foreign currency exchange rates. In the fourth quarter of 2015, the company experienced supply challenges that disrupted the ability to fully supply certain markets.
- Defitelio® (defibrotide): 2015 Defitelio/defibrotide net sales were $70.7 million compared to 2014 full year pro forma Defitelio/defibrotide net sales of $73.4 million. Defitelio/defibrotide net sales from the period beginning from the closing of its acquisition of Gentium S.r.l. on January 23, 2014 to December 31, 2014 were $70.5 million. Defitelio/defibrotide net sales were $18.5 million in the fourth quarter of 2015 compared to $19.2 million in the fourth quarter of 2014. Product sales volume for the full year and fourth quarter of 2015 was consistent with the company’s expectations and higher than the same periods in 2014, but net sales were impacted by unfavorable foreign currency exchange rates.
- Prialt® (ziconotide) intrathecal infusion: Prialt net sales were $26.4 million in both 2015 and 2014. Prialt net sales were $6.5 million in the fourth quarter of 2015 compared to $10.0 million in the fourth quarter of 2014. Net sales in the fourth quarter of 2014 included shipments to Eisai Co., the European distributor of Prialt.
- Psychiatry products: 2015 net sales of the company’s psychiatry products were $37.1 million compared to $40.9 million in the prior year. Net sales of the company’s psychiatry products were $8.8 million in the fourth quarter of 2015 compared to $8.4 million in the fourth quarter of 2014.
- Other: 2015 net sales of other products were $24.1 million compared to 2014 full year pro forma net sales of other products of $47.0 million. Net sales of other products in the fourth quarter of 2015 were $3.0 million compared to $11.3 million in the fourth quarter of 2014. In March 2015, the company completed the sale of certain products and the related business that the company acquired as part of the acquisition of EUSA Pharma Inc. in 2012.
Tables showing actual net product sales for the three months and year ended December 31, 2015 and 2014 and pro forma net product sales for the year ended December 31, 2014 are included in this press release.
Operating Expenses and Other
Operating expenses for 2015 were $816.6 million compared to $977.3 million for 2014. Operating expenses for 2014 included acquired in-process research and development expenses of $202.6 million. Operating expenses for the fourth quarter of 2015 were $234.3 million compared to $198.2 million for the fourth quarter of 2014. Operating expenses changed over the prior year periods primarily due to the following:
- Cost of product sales for 2015 was $102.5 million compared to $117.4 million for 2014. Cost of product sales for the fourth quarter of 2015 was $24.0 million compared to $28.8 million for the same period in 2014. Gross margin for 2015 was 92.2% compared to 89.9% for 2014. Gross margin for the fourth quarter of 2015 was 92.9% compared to 91.1% for the same period in 2014.
- Selling, general and administrative (SG&A) expenses for 2015 on a GAAP basis were $449.1 million compared to $406.1 million for 2014. SG&A expenses for the fourth quarter of 2015 on a GAAP basis were $125.6 million compared to $105.7 million for the same period in 2014. Adjusted SG&A expenses for 2015 were $355.4 million, or 27% of total revenues, compared to $321.5 million, or 27% of total revenues, for 2014. Adjusted SG&A expenses for the fourth quarter of 2015 were $87.4 million, or 26% of total revenues, compared to $83.5 million, or 25% of total revenues, for the same period in 2014. The increases were primarily due to higher headcount and other expenses resulting from the expansion of the company’s business, except that the increase in GAAP SG&A expenses for the fourth quarter of 2015 compared to the same period in 2014 was primarily due to a one-time charge for settlement of a contract claim originally asserted against Azur Pharma Public Limited Company (Azur Pharma) prior to the 2012 merger between Azur Pharma and Jazz Pharmaceuticals, Inc.
- Research and development (R&D) expenses for 2015 on a GAAP basis were $135.3 million compared to $85.2 million for 2014. R&D expenses for the fourth quarter of 2015 on a GAAP basis were $29.5 million compared to $24.6 million for the same period in 2014. Adjusted R&D expenses for 2015 were $96.7 million, or 7% of total revenues, compared to $71.8 million, or 6% of total revenues, for 2014. Adjusted R&D expenses for the fourth quarter of 2015 were $26.0 million, or 8% of total revenues, compared to $21.2 million, or 6% of total revenues, for the same period in 2014. The increases were primarily due to higher costs for clinical studies and outside services for the development of JZP-110 and line extensions for the company’s existing products, except that the increase in GAAP R&D expenses for full year 2015 compared to the same period in 2014 was primarily due to a $25.0 million milestone payment that was triggered by the acceptance for filing by the U.S. Food and Drug Administration (FDA) of the first new drug application (NDA) for defibrotide.
- Acquired in-process research and development expenses of $202.6 million in 2014 primarily related to upfront and milestone payments of $127.0 million made in connection with the acquisition of rights to JZP-110 and an upfront payment of $75.0 million made in connection with the acquisition of rights to defibrotide in the Americas.
- Impairment charges of $31.5 million in 2015 resulted from the termination of the suspended JZP-416 study. Impairment charges of $39.4 million in 2014 related to certain products we sold in March 2015 that we acquired as part of the EUSA acquisition.
Net interest expense in 2015 was $56.9 million compared to $52.7 million for 2014. Net interest expense for the fourth quarter of 2015 was $12.2 million compared to $16.7 million for the fourth quarter of 2014. In June 2015, the company refinanced its existing term loans and revolving credit facility and obtained more favorable interest rates, which reduced interest expense in the second half of 2015.
As of December 31, 2015, cash and cash equivalents were $988.8 million, and the outstanding principal balance of the company’s long-term debt was $1.3 billion. Cash and cash equivalents increased during 2015 primarily due to cash generated by the business.
During 2015, the company repurchased 0.4 million ordinary shares for $61.6 million at an average cost of $150.24 per ordinary share.
2016 Financial Guidance
Jazz Pharmaceuticals’ full year 2016 financial guidance is as follows:
Revenues | $1,490-$1,550 million |
Total net product sales | $1,482-$1,542 million |
-Xyrem net sales | $1,095-$1,130 million |
-Erwinaze/Erwinase net sales | $200-$225 million |
-Defitelio/defibrotide net sales1 | $100-$125 million |
Adjusted gross margin %2,5 | 93% |
Adjusted SG&A expenses3,5 | $390-$410 million |
Adjusted R&D expenses4,5 | $115-$130 million |
GAAP net income per diluted share | $6.76-$7.41 |
Non-GAAP adjusted net income per diluted share5 | $10.90-$11.30 |
1. | Guidance assumes FDA approval of the defibrotide NDA is completed on the Prescription Drug User Fee Act date of March 31, 2016. | |||
2. | Excludes $6 million of share-based compensation expense from estimated GAAP gross margin of 93%. | |||
3. | Excludes $87-$95 million of share-based compensation expense from estimated GAAP SG&A expenses of $477-$505 million. | |||
4. | Excludes $17-$19 million of share-based compensation expense from estimated GAAP R&D expenses of $132-$149 million. | |||
5. | See “Non-GAAP Financial Measures” below. Reconciliations of non-GAAP adjusted guidance measures are included above and in the tables accompanying this press release. | |||
Conference Call Details
Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. EST (9:30 p.m. GMT) to provide a business and financial update and discuss its 2015 full year and fourth quarter results and provide 2016 financial guidance. The live webcast may be accessed from the Investors & Media section of the company’s website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary. Investors may participate in the conference call by dialing +1 855 306 9240 in the U.S., or +1 440 996 5718 outside the U.S., and entering passcode 33458357.
A replay of the conference call will be available through March 1, 2016 by dialing +1 855 859 2056 in the U.S., or +1 404 537 3406 outside the U.S., and entering passcode 33458357. An archived version of the webcast will be available for at least one week in the Investors & Media section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com.
About Jazz Pharmaceuticals plc
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. The company has a diverse portfolio of products and product candidates with a focus in the areas of sleep and hematology/oncology. In these areas, Jazz Pharmaceuticals markets Xyrem® (sodium oxybate) oral solution and Erwinaze® (asparaginase Erwinia chrysanthemi) in the U.S., and markets Erwinase® and Defitelio® (defibrotide) in countries outside the U.S. For more information, please visit www.jazzpharmaceuticals.com.
Non-GAAP Financial Measures
To supplement Jazz Pharmaceuticals’ financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the company uses certain non-GAAP (also referred to as adjusted or non-GAAP adjusted) financial measures in this press release and the accompanying tables. The company believes that each of these non-GAAP financial measures is helpful in understanding its past financial performance and potential future results, particularly in light of the effect of various acquisition and divestiture transactions effected by the company. They are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with the consolidated financial statements prepared in accordance with GAAP. Jazz Pharmaceuticals’ management regularly uses these supplemental non-GAAP financial measures internally to understand, manage and evaluate its business and make operating decisions. Compensation of executives is based in part on the performance of the company’s business based on certain of these non-GAAP financial measures. In addition, Jazz Pharmaceuticals believes that the presentation of these non-GAAP financial measures is useful to investors because it enhances the ability of investors to compare the company’s results from period to period and allows for greater transparency with respect to key financial metrics the company uses in making operating decisions, and also because the company’s investors and analysts regularly use them to model and track the company’s financial performance.
Investors should note that these non-GAAP financial measures are not prepared under any comprehensive set of accounting rules or principles and do not reflect all of the amounts associated with the company’s results of operations as determined in accordance with GAAP. Investors should also note that these non-GAAP financial measures have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. In addition, from time to time in the future there may be other items that the company may exclude for purposes of its non-GAAP financial measures; and the company has ceased, and may in the future cease, to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. In this regard, commencing with the company’s presentation of 2015 non-GAAP financial measures, the company no longer includes an adjustment for depreciation expense in its non-GAAP adjusted financial measures. Likewise, for purposes of comparability, non-GAAP adjusted financial measures for 2014 included in this press release and accompanying tables do not include an adjustment for depreciation expense. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by Jazz Pharmaceuticals in this press release and the accompanying tables may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by the company’s competitors and other companies.
“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to Jazz Pharmaceuticals’ future financial and operating results, including its 2016 financial guidance, growth of the company’s key commercial products, the anticipated commercial launch of defibrotide in the U.S., achievement of clinical milestones, potential expansion of the company’s commercial and development portfolio and other statements that are not historical facts. These forward-looking statements are based on the company’s current plans, objectives, estimates, expectations and intentions, 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 and uncertainties associated with maintaining or increasing sales of and revenue from Xyrem, such as the potential introduction of generic competition or other competitive sodium oxybate products; regulatory restrictions and requirements applicable to Xyrem and ongoing patent litigation and related proceedings; the company’s ability to effectively commercialize its other products; the company’s ability to effectively commercialize its product candidates, including defibrotide in the U.S.; protecting and enhancing the company’s intellectual property rights; delays or problems in the supply or manufacture of the company’s products and product candidates; obtaining and maintaining appropriate pricing and reimbursement for the company’s products; complying with the requirements of U.S. and non-U.S. regulatory agencies; the difficulty and uncertainty of pharmaceutical product development and the uncertainty of clinical success; the uncertainty associated with the regulatory approval process, including the risk that the company may be unable to obtain regulatory approval for defibrotide in the U.S. in a timely manner, or at all; the ability to identify and acquire, in-license or develop additional products or product candidates to grow the company’s business and the risks associated with identifying, financing and integrating these transactions; the uncertainty of expected future financial performance and results; and other risks and uncertainties affecting the company, including those described from time to time under the caption “Risk Factors” and elsewhere in Jazz Pharmaceuticals plc’s Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2015 and future filings and reports by the company, including the company’s Annual Report on Form 10-K for the year ended December 31, 2015. Other risks and uncertainties of which the company is not currently aware may also affect the company’s forward-looking statements and may cause actual results and timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by the company on its website or otherwise.
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