Full Press Release Details
DUBLIN , Aug. 7, 2012 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ ) today announced financial results for the second quarter ended June 30 , 2012. These results include the first complete quarter of financial results following the Azur Pharma plc merger, as well as a partial month of results following completion of the acquisition of EUSA Pharma Inc. on June 12, 2012 . Results for 2011 reflect only the financial results reported by Jazz Pharmaceuticals, Inc.
"The first six months of 2012 have been a time of tremendous progress for Jazz Pharmaceuticals as we've delivered strong organic sales growth led by Xyrem ® and completed two important transactions. The Azur and EUSA acquisitions added attractive new products to our portfolio, brought increased depth to our team and expanded our geographic footprint," said Bruce Cozadd , chairman and chief executive officer of Jazz Pharmaceuticals. "We are particularly pleased by our year-over-year and sequential growth in adjusted net income, and we remain committed to our strategy of increasing sales of our current products, growing our product portfolio through corporate development and investing in focused development programs."
Adjusted net income for the second quarter of 2012 was $66.2 million , or $1.09 per diluted share, reflecting both strong organic growth and the positive impact of the Azur Pharma and EUSA Pharma acquisitions. GAAP net income for the second quarter of 2012 was impacted by various non-recurring acquisition-related expenses and non-cash amortization expenses. For the quarter, GAAP net income was $27.1 million , or $0.45 per diluted share. A reconciliation of GAAP net income to adjusted net income and the related per diluted share amounts is included with this press release.
Revenues and Product Sales
Total revenues for the quarter ended June 30, 2012 were $129.5 million , including net sales, royalties and contract revenues.
Total net sales for the second quarter of 2012 increased to $128.3 million , driven by significant growth in Xyrem (sodium oxybate) oral solution net sales, as well as the addition of net sales from the expanded product portfolio resulting from the merger with Azur Pharma and a partial month of sales of Erwinaze ® (asparaginase Erwinia chrysanthemi ) and other products from the EUSA Pharma acquisition.
Net sales for the second quarter of 2012 included:
Other Financial Highlights
Additional financial information for the second quarter of 2012 includes:
2012 Financial Guidance
Jazz Pharmaceuticals is also providing the following updated financial guidance for 2012, which reflects the EUSA Pharma acquisition and expected results from and after June 12, 2012 :
| Total Revenues | $605-$615 million |
| Total Net Product Sales | $600-$610 million |
| -Xyrem Net Sales -Erwinaze/Erwinase Net Sales | $375-$380 million $65-$69 million |
| Total Gross Margin % 1 | 85%-88% |
| Combined SG&A and R&D expenses 2 | $260-$270 million |
| GAAP Net Income | $139-$154 million |
| GAAP Net Income Per Diluted Share | $2.34-$2.57 |
| Adjusted Net Income 3 | $282-$291 million |
| Adjusted Net Income Per Diluted Share 3 | $4.70-$4.85 |
| 1. | Includes $19 million of purchase accounting inventory fair value step-up. |
| 2. | Includes share-based compensation, transaction and integration costs and change in fair value of contingent consideration related to the Azur Pharma and EUSA Pharma transactions of $49-$52 million. |
| 3. | A reconciliation of GAAP net income to adjusted net income and the related per diluted share amounts is included with this press release. |
Conference Call Details
Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. EDT ( 9:30 p.m. IST ) to provide a business and financial update and discuss 2012 second quarter results and 2012 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 +1 866-804-6921 in the U.S., or +1 857-350-1667 outside the U.S., and entering passcode 13817577.
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
Jazz Pharmaceuticals plc is a specialty biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing products that address unmet medical needs. The company has a diverse portfolio of products in the areas of narcolepsy, oncology, pain, psychiatry and women's health. The company's U.S. marketed products in these areas include: Xyrem ® (sodium oxybate), Erwinaze ® (asparaginase Erwinia chrysanthemi ), Prialt ® (ziconotide) intrathecal infusion, FazaClo ® (clozapine, USP) HD and FazaClo LD, Luvox CR ® (fluvoxamine maleate) and Elestrin ® (estradiol gel). Outside of the U.S., Jazz Pharmaceuticals also has a number of products marketed by its international division, EUSA Pharma.
Non-GAAP Financial Measures
"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 results, strategy and growth potential, including 2012 financial guidance, and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals' 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 and uncertainties associated with maintaining and increasing sales of and revenue from Xyrem, such as the potential introduction of generic competition and changed or increased regulatory restrictions on Xyrem, as well as similar risks related to effectively commercializing the company's other marketed products, including Erwinaze and Prialt; successfully integrating and growing Jazz Pharmaceuticals' combined business operations after the Azur Pharma merger and EUSA Pharma acquisition, which may be more difficult, time-consuming or costly than expected, particularly in light of the company's expanded international footprint; obtaining appropriate pricing and reimbursement for the company's products in an increasingly challenging environment; ongoing regulation and oversight by U.S. and foreign regulatory agencies; dependence on key customers and sole source suppliers; the company's ability to protect intellectual property rights with respect to its products; the difficulty and uncertainty of pharmaceutical product development and the uncertainty of clinical success and regulatory approval; and potential restrictions on the company's ability and flexibility to pursue future opportunities as a result of its substantial outstanding debt obligations; as well as risks related to future opportunities and plans, including the uncertainty of expected future financial performance and results; and those risks detailed 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2012 , as updated by the Current Reports on Form 8-K filed on June 4, 2012 and July 9, 2012 , respectively, and future filings and reports by the company, including the Quarterly Report on Form 10-Q for the quarter ended June 30, 2012 . Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.
| JAZZ PHARMACEUTICALS PLC | |||||||
| CONDENSED CONSOLIDATED STATEMENTS OF INCOME | |||||||
| (In thousands, except per share amounts) | |||||||
| (Unaudited) | |||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||
| 2012 | 2011 | 2012 | 2011 | ||||
| Revenues: | |||||||
| Product sales, net | $ 128,310 | $ 63,464 | $ 235,646 | $ 113,367 | |||
| Royalties and contract revenues | 1,229 | 1,103 | 2,307 | 2,081 | |||
| Total revenues | 129,539 | 64,567 | 237,953 | 115,448 | |||
| Operating expenses: | |||||||
| Cost of product sales | 15,370 | 3,370 | 26,128 | 6,179 | |||
| Selling, general and administrative | 60,638 | 22,094 | 107,637 | 42,005 | |||
| Research and development | 2,321 | 3,382 | 6,280 | 7,077 | |||
| Intangible asset amortization | 15,751 | 1,862 | 29,264 | 3,724 | |||
| Total operating expenses | 94,080 | 30,708 | 169,309 | 58,985 | |||
| Income from operations | 35,459 | 33,859 | 68,644 | 56,463 | |||
| Interest expense, net | (1,481) | (657) | (1,450) | (1,434) | |||
| Other expense | (240) | - | (258) | - | |||
| Income before provision for income | |||||||
| tax expense | 33,738 | 33,202 | 66,936 | 55,029 | |||
| Provision for income tax expense | 6,593 | - | 12,110 | - | |||
| Net income | $ 27,145 | $ 33,202 | $ 54,826 | $ 55,029 | |||
| Net income per share: | |||||||
| Basic | $ 0.48 | $ 0.81 | $ 0.99 | $ 1.35 | |||
| Diluted | $ 0.45 | $ 0.71 | $ 0.92 | $ 1.19 | |||
| Weighted-average ordinary shares used | |||||||
| in computing net income per share: | |||||||
| Basic | 56,952 | 41,209 | 55,437 | 40,788 | |||
| Diluted | 60,554 | 46,601 | 59,319 | 46,238 | |||
| JAZZ PHARMACEUTICALS PLC | |||||||
| SUMMARY OF PRODUCT SALES, NET | |||||||
| (In thousands) | |||||||
| (Unaudited) | |||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||
| 2012 | 2011 | 2012 | 2011 | ||||
| Xyrem | $ 89,097 | $ 56,178 | $ 162,534 | $ 98,956 | |||
| Erwinaze/Erwinase (1) | 6,007 | - | 6,007 | - | |||
| Prialt (1) | 5,555 | - | 15,077 | - | |||
| Psychiatry: | |||||||
| Luvox CR | 10,471 | 7,286 | 20,029 | 14,411 | |||
| FazaClo LD (1) | 5,956 | - | 11,535 | - | |||
| FazaClo HD (1) | 3,362 | - | 5,922 | - | |||
| Other (1) | 7,862 | - | 14,542 | - | |||
| Total | $ 128,310 | $ 63,464 | $ 235,646 | $ 113,367 |
| (1) | Net sales for the three and six months ended June 30, 2012 reported by Jazz Pharmaceuticals plc include net sales from the historic Azur Pharma business for the period from April 1, 2012 through June 30, 2012 and from January 18, 2012 through June 30, 2012 and net product sales from the historic EUSA Pharma business for the period from June 12, 2012 through June 30, 2012. |
| The following unaudited pro forma information represents the combined net product sales for the three and six months ended June 30, 2012 and 2011, respectively, as if the merger with Azur Pharma and the acquisition of EUSA Pharma had each been completed on January 1, 2011: |
| SUMMARY OF PRODUCT SALES, NET (PRO FORMA) | |||||||
| (In thousands) | |||||||
| (Unaudited) | |||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||
| 2012 | 2011 | 2012 | 2011 | ||||
| Xyrem | $ 89,097 | $ 56,178 | $ 162,534 | $ 98,956 | |||
| Erwinaze/Erwinase | 32,888 | 8,882 | 65,795 | 16,048 | |||
| Prialt | 5,555 | 4,969 | 15,417 | 9,843 | |||
| Psychiatry: | |||||||
| Luvox CR | 10,471 | 7,286 | 20,029 | 14,411 | |||
| FazaClo LD | 5,956 | 7,557 | 11,768 | 14,302 | |||
| FazaClo HD | 3,362 | 1,901 | 6,052 | 3,216 | |||
| Other | 17,447 | 21,311 | 36,346 | 43,085 | |||
| Total pro forma net sales | $ 164,776 | $ 108,084 | $ 317,941 | $ 199,861 |
| JAZZ PHARMACEUTICALS PLC | |||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||
| (In thousands) | |||
| (Unaudited) | |||
| June 30, | December 31, | ||
| 2012 | 2011 | ||
| ASSETS | |||
| Current assets: | |||
| Cash and cash equivalents | $ 154,543 | $ 82,076 | |
| Marketable securities | - | 75,822 | |
| Accounts receivable, net | 78,130 | 34,374 | |
| Inventories | 48,355 | 3,909 | |
| Prepaid expenses | 5,906 | 1,690 | |
| Other current assets | 13,508 | 1,260 | |
| Total current assets | 300,442 | 199,131 | |
| Property and equipment, net | 4,631 | 1,557 | |
| Intangible assets, net | 927,409 | 14,585 | |
| Goodwill | 446,236 | 38,213 | |
| Other long-term assets | 19,226 | 87 | |
| Total assets | $ 1,697,944 | $ 253,573 | |
| LIABILITIES AND SHAREHOLDERS' EQUITY | |||
| Current liabilities: | |||
| Accounts payable | $ 34,505 | $ 5,129 | |
| Accrued liabilities | 125,080 | 34,783 | |
| Current portion of long-term debt | 23,750 | - | |
| Purchased product rights liability | 6,972 | 4,500 | |
| Liability under government settlement | - | 7,320 | |
| Deferred revenue | 2,011 | 1,138 | |
| Total current liabilities | 192,318 | 52,870 | |
| Deferred revenue, non-current | 7,356 | 7,915 | |
| Long-term debt, less current portion | 444,190 | - | |
| Contingent consideration | 35,300 | - | |
| Deferred tax liability | 185,706 | - | |
| Other non-current liabilities | 1,615 | - | |
| Total shareholders' equity | 831,459 | 192,788 | |
| Total liabilities and shareholders' equity | $ 1,697,944 | $ 253,573 |
| JAZZ PHARMACEUTICALS PLC | |||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF INCOME AND RECONCILIATION OF NON-GAAP ADJUSTMENTS | |||||||||||
| (In thousands, except per share amounts) | |||||||||||
| (Unaudited) | |||||||||||
| Three Months Ended | |||||||||||
| June 30, 2012 | June 30, 2011 | ||||||||||
| GAAP | Adjustments | Non-GAAP | GAAP | Adjustments | Non-GAAP | ||||||
| Revenues: | |||||||||||
| Product sales, net | $ 128,310 | $ - | $ 128,310 | $ 63,464 | $ - | $ 63,464 | |||||
| Royalties and contract revenues | 1,229 | - | 1,229 | 1,103 | (284) | (e) | 819 | ||||
| Total revenues | 129,539 | - | 129,539 | 64,567 | (284) | 64,283 | |||||
| Operating expenses: | |||||||||||
| Cost of product sales | 15,370 | (4,305) | (a)(b) | 11,065 | 3,370 | (149) | (b) | 3,221 | |||
| Selling, general and administrative | 60,638 | (15,283) | (b)(c) | 45,355 | 22,094 | (2,418) | (b) | 19,676 | |||
| Research and development | 2,321 | (522) | (b) | 1,799 | 3,382 | (848) | (b) | 2,534 | |||
| Intangible asset amortization | 15,751 | (15,751) | - | 1,862 | (1,862) | - | |||||
| Total operating expenses | 94,080 | (35,861) | 58,219 | 30,708 | (5,277) | 25,431 | |||||
| Income from operations | 35,459 | 35,861 | 71,320 | 33,859 | 4,993 | 38,852 | |||||
| Interest expense, net | (1,481) | 267 | (d) | (1,214) | (657) | 188 | (d) | (469) | |||
| Other expense | (240) | - | (240) | - | - | - | |||||
| Income before provision for income | |||||||||||
| tax expense | 33,738 | 36,128 | 69,866 | 33,202 | 5,181 | 38,383 | |||||
| Provision for income tax expense | 6,593 | (2,897) | 3,696 | - | - | - | |||||
| Net income | $ 27,145 | $ 39,025 | $ 66,170 | $ 33,202 | $ 5,181 | $ 38,383 | |||||
| Net income per share: | |||||||||||
| Basic | $ 0.48 | $ 1.16 | $ 0.81 | $ 0.93 | |||||||
| Diluted | $ 0.45 | $ 1.09 | $ 0.71 | $ 0.82 | |||||||
| Weighted-average ordinary shares used | |||||||||||
| in computing net income per share: | |||||||||||
| Basic | 56,952 | 56,952 | 41,209 | 41,209 | |||||||
| Diluted | 60,554 | 60,554 | 46,601 | 46,601 | |||||||
| (a) Purchase accounting inventory fair value step-up of $4,011. | |||||||||||
| (b) Share-based compensation expense. | |||||||||||
| (c) Transaction and integration costs of $10,641 plus change in fair value of contingent consideration of $200. | |||||||||||
| (d) Interest associated with debt discount and debt issuance costs and, to a small extent, liability under a 2007 government litigation settlement. | |||||||||||
| (e) Revenue related to upfront and milestone payments. | |||||||||||
| JAZZ PHARMACEUTICALS PLC | |||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF INCOME AND RECONCILIATION OF NON-GAAP ADJUSTMENTS | |||||||||||
| (In thousands, except per share amounts) | |||||||||||
| (Unaudited) | |||||||||||
| Six Months Ended | |||||||||||
| June 30, 2012 | June 30, 2011 | ||||||||||
| GAAP | Adjustments | Non-GAAP | GAAP | Adjustments | Non-GAAP | ||||||
| Revenues: | |||||||||||
| Product sales, net | $ 235,646 | $ - | $ 235,646 | $ 113,367 | $ - | $ 113,367 | |||||
| Royalties and contract revenues | 2,307 | - | 2,307 | 2,081 | (569) | (e) | 1,512 | ||||
| Total revenues | 237,953 | - | 237,953 | 115,448 | (569) | 114,879 | |||||
| Operating expenses: | |||||||||||
| Cost of product sales | 26,128 | (7,035) | (a)(b) | 19,093 | 6,179 | (229) | (b) | 5,950 | |||
| Selling, general and administrative | 107,637 | (23,783) | (b)(c) | 83,854 | 42,005 | (4,830) | (b) | 37,175 | |||
| Research and development | 6,280 | (1,037) | (b) | 5,243 | 7,077 | (1,504) | (b) | 5,573 | |||
| Intangible asset amortization | 29,264 | (29,264) | - | 3,724 | (3,724) | - | |||||
| Total operating expenses | 169,309 | (61,119) | 108,190 | 58,985 | (10,287) | 48,698 | |||||
| Income from operations | 68,644 | 61,119 | 129,763 | 56,463 | 9,718 | 66,181 | |||||
| Interest expense, net | (1,450) | 309 | (d) | (1,141) | (1,434) | 394 | (d) | (1,040) | |||
| Other expense | (258) | - | (258) | - | - | - | |||||
| Income before provision for income | |||||||||||
| tax expense | 66,936 | 61,428 | 128,364 | 55,029 | 10,112 | 65,141 | |||||
| Provision for income tax expense | 12,110 | (2,897) | 9,213 | - | - | - | |||||
| Net income | $ 54,826 | $ 64,325 | $ 119,151 | $ 55,029 | $ 10,112 | $ 65,141 | |||||
| Net income per share: | |||||||||||
| Basic | $ 0.99 | $ 2.15 | $ 1.35 | $ 1.60 | |||||||
| Diluted | $ 0.92 | $ 2.01 | $ 1.19 | $ 1.41 | |||||||
| Weighted-average ordinary shares used | |||||||||||
| in computing net income per share: | |||||||||||
| Basic | 55,437 | 55,437 | 40,788 | 40,788 | |||||||
| Diluted | 59,319 | 59,319 | 46,238 | 46,238 | |||||||
| (a) Purchase accounting inventory fair value step-up of $6,380. | |||||||||||
| (b) Share-based compensation expense. | |||||||||||
| (c) Transaction and integration costs of $16,736 plus change in fair value of contingent consideration of $200. | |||||||||||
| (d) Interest associated with debt discount and debt issuance costs and, to a small extent, liability under a 2007 government litigation settlement. | |||||||||||
| (e) Revenue related to upfront and milestone payments. |
| JAZZ PHARMACEUTICALS PLC | |||||||
| RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES | |||||||
| (In thousands, except per share amounts) | |||||||
| (Unaudited) | |||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||
| 2012 | 2011 | 2012 | 2011 | ||||
| GAAP net income | $ 27,145 | $ 33,202 | $ 54,826 | $ 55,029 | |||
| Intangible asset amortization | 15,751 | 1,862 | 29,264 | 3,724 | |||
| Share-based compensation expense | 5,258 | 3,415 | 8,539 | 6,563 | |||
| Purchase accounting inventory fair value step-up | 4,011 | - | 6,380 | - | |||
| Transaction and integration costs | 10,641 | - | 16,736 | - | |||
| Change in fair value of contingent consideration | 200 | - | 200 | - | |||
| Other non-cash expense (income) | 267 | (96) | 309 | (175) | |||
| Income tax adjustments | 2,897 | - | 2,897 | - | |||
| Adjusted net income | $ 66,170 | $ 38,383 | $ 119,151 | $ 65,141 | |||
| GAAP net income per diluted share | $ 0.45 | $ 0.71 | $ 0.92 | $ 1.19 | |||
| Adjusted net income per diluted share | $ 1.09 | $ 0.82 | $ 2.01 | $ 1.41 | |||
| Shares used in computing GAAP and adjusted | |||||||
| net income per diluted share amounts | 60,554 | 46,601 | 59,319 | 46,238 |
| JAZZ PHARMACEUTICALS PLC | |
| RECONCILIATION OF GAAP TO NON-GAAP 2012 FINANCIAL GUIDANCE | |
| (In millions, except per share amounts) | |
| GAAP net income | $139 - $154 |
| Intangible asset amortization | 70 |
| Share-based compensation expense | 25 - 26 |
| Purchase accounting inventory fair value step-up | 18 - 20 |
| Transaction and integration costs | 22 - 24 |
| Change in fair value of contingent consideration | 2 |
| Other non-cash expense | 3 |
| Income tax adjustments | (2 - 3) |
| Adjusted net income | $282 - $291 |
| GAAP net income per diluted share | $2.34 - $2.57 |
| Adjusted net income per diluted share | $4.70 - $4.85 |
| Shares used in computing GAAP and adjusted | |
| net income per diluted share amounts | 60 |
SOURCE Jazz Pharmaceuticals plc