GAAP net income for the third quarter of 2017 was $63.5M, or $1.03 per diluted share, compared to $89.8M, or $1.45 per diluted share, for the third quarter of 2016.
Total Revenues Increased 10% to $412 Million
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[07-November-2017] |
DUBLIN, Nov. 7, 2017 /PRNewswire/ -- Jazz Pharmaceuticals (Nasdaq: JAZZ) today announced financial results for the third quarter of 2017 and updated financial guidance for 2017. “The third quarter of 2017 was highlighted by the approval and strong launch of Vyxeos in the U.S. for the treatment of adult patients with newly-diagnosed high-risk AML, leading to our increase in 2017 Vyxeos sales guidance,” said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. “While Xyrem has experienced lower than expected growth in 2017, and we are slightly decreasing our annual sales guidance accordingly, we remain confident in our ability to address the key drivers impacting Xyrem to position the product for solid future growth.” GAAP net income for the third quarter of 2017 was $63.5 million, or $1.03 per diluted share, compared to $89.8 million, or $1.45 per diluted share, for the third quarter of 2016. GAAP net income for the third quarter of 2017 included an upfront payment of $75.0 million to ImmunoGen, Inc. related to a collaboration and option agreement. Adjusted net income for the third quarter of 2017 was $197.6 million, or $3.22 per diluted share, compared to $161.2 million, or $2.61 per diluted share, for the third quarter of 2016. The tax provision and the effective tax rate for the third quarter of 2017 on both a GAAP and non-GAAP basis were favorably impacted by certain tax benefits. For further information, see “Operating Expenses and Income Tax Provision” below. Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release. Financial Highlights Three Months Ended Nine Months Ended September 30, September 30, ------------- ------------- (In thousands, except per share amounts and percentages) 2017 2016 Change 2017 2016 Change ---- ---- ------ ---- ---- ------ Total revenues $411,855 $374,181 10% $1,182,294 $1,091,352 8% GAAP net income $63,526 $89,828 (29)% $255,641 $280,142 (9)% Adjusted net income $197,649 $161,153 23% $496,225 $461,525 8% GAAP EPS $1.03 $1.45 (29)% $4.17 $4.51 (8)% Adjusted EPS $3.22 $2.61 23% $8.09 $7.43 9% Total Revenues Three Months Ended Nine Months Ended September 30, September 30, ------------- ------------- (In thousands) 2017 2016 2017 2016 ---- ---- Xyrem(R) (sodium oxybate) oral solution $303,870 $285,907 $874,222 $816,412 Erwinaze(R) /Erwinase(R) (asparaginase Erwinia chrysanthemi) 49,173 42,986 149,585 143,907 Defitelio(R) (defibrotide sodium) / defibrotide 31,213 28,137 97,351 79,280 VyxeosTM (daunorubicin and cytarabine) liposome for injection 9,719 - 9,719 - Prialt(R) (ziconotide) intrathecal infusion 7,930 8,783 21,303 23,065 Other 6,066 5,808 19,124 21,983 ----- ----- ------ ------ Product sales, net 407,971 371,621 1,171,304 1,084,647 Royalties and contract revenues 3,884 2,560 10,990 6,705 Total revenues $411,855 $374,181 $1,182,294 $1,091,352 ======== ======== ========== ========== Net product sales increased 10% in the third quarter of 2017 compared to the same period in 2016 primarily due to an increase in net product sales of our lead marketed products. Xyrem net product sales increased 6% in the third quarter of 2017 compared to the same period in 2016. Xyrem net product sales growth in the 2017 period was negatively impacted by payer mix, one fewer shipping day, and operational changes that delayed some prescription fulfillment. Erwinaze/Erwinase net product sales increased 14% in the third quarter of 2017 compared to the same period in 2016. The company experienced supply disruptions during both periods; however, net product sales were higher in the third quarter of 2017 compared to the same period in 2016 due to the timing of product availability. The company expects that additional supply disruptions may occur in 2017 and into 2018. Defitelio/defibrotide net product sales increased 11% in the third quarter of 2017 compared to the same period in 2016 primarily due to an increase in U.S. net product sales. The company expects continued inter-quarter variability in Defitelio net sales given that veno-occlusive disease is an ultra-rare disease. Vyxeos net product sales in the third quarter of 2017 were $9.7 million. Vyxeos launched in the U.S. on August 11, 2017. Operating Expenses and Income Tax Provision Three Months Ended Nine Months Ended September 30, September 30, ------------- ------------- (In thousands, except percentages) 2017 2016 2017 2016 ---- ---- ---- ---- GAAP: Cost of product sales $31,203 $24,311 $84,940 $71,730 Gross margin 92.4% 93.5% 92.7% 93.4% Selling, general and administrative $124,523 $124,368 $401,106 $375,751 % of total revenues 30.2% 33.2% 33.9% 34.4% Research and development $47,362 $47,796 $132,447 $118,139 % of total revenues 11.5% 12.8% 11.2% 10.8% Acquired in-process research and development $75,000 $15,000 $77,000 $23,750 Income tax provision $1,239 $26,437 $65,914 $100,888 Effective tax rate 1.9% 22.7% 20.5% 26.5% Three Months Ended Nine Months Ended September 30, September 30, ------------- ------------- (In thousands, except percentages) 2017 2016 2017 2016 ---- ---- ---- ---- Non-GAAP adjusted: Cost of product sales $29,630 $22,963 $80,594 $68,620 Gross margin 92.7% 93.8% 93.1% 93.7% Selling, general and administrative $103,620 $94,534 $333,524 $296,633 % of total revenues 25.2% 25.3% 28.2% 27.2% Research and development $42,712 $43,323 $118,796 $106,847 % of total revenues 10.4% 11.6% 10.0% 9.8% Income tax provision $24,410 $38,500 $104,307 $129,663 Effective tax rate 11.0% 19.3% 17.4% 21.9% Operating expenses changed over the prior year period primarily due to the following:
The tax provision and the effective tax rate for the third quarter of 2017 on both a GAAP and non-GAAP basis were favorably impacted by the release of a valuation allowance held against certain foreign net operating losses and the release of reserves related to uncertain tax positions upon the expiration of a statute of limitation. Cash Flow and Balance Sheet Recent Developments
2017 Financial Guidance Revenues $1,600-$1,650 Total net product sales $1,590-$1,630 -Xyrem net sales $1,180-$1,200 -Erwinaze/Erwinase net sales $200-$215 -Defitelio/defibrotide net sales $130-$150 -Vyxeos net sales $20-$30 GAAP gross margin % 93% Non-GAAP adjusted gross margin %1,4 93% GAAP SG&A expenses $521-$551 Non-GAAP adjusted SG&A expenses2,4 $440-$460 GAAP R&D expenses $180-$200 Non-GAAP adjusted R&D expenses3,4 $165-$180 GAAP net income per diluted share $5.30-$6.30 Non-GAAP adjusted net income per diluted share4 $10.70-$11.20 Excludes $5 million of share-based compensation expense from estimated GAAP 1. gross margin. 2. Excludes $75- $85 million of share-based compensation expense and $6 million of expenses related to certain legal proceedings and restructuring from estimated GAAP SG&A expenses. Excludes $15- $20 million of share-based compensation expense from estimated GAAP 3. R&D expenses. 4. See “Non-GAAP Financial Measures” below. Reconciliations of non-GAAP adjusted guidance measures are included above and in the table titled “Reconciliation of GAAP to Non-GAAP Adjusted 2017 Net Income Guidance” at the end of this press release. Conference Call Details A replay of the conference call will be available through November 14, 2017 by dialing +1 855 859 2056 in the U.S., or +1 404 537 3406 outside the U.S., and entering passcode 95499424. An archived version of the webcast will be available for at least one week in the Investors section of the company’s website at www.jazzpharmaceuticals.com. About Jazz Pharmaceuticals plc Non-GAAP Financial Measures The company believes that each of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors and analysts. In particular, the company believes that each of these non-GAAP financial measures, when considered together with the company’s financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare the company’s results from period to period and to its forward-looking guidance, and to identify operating trends in the company’s business. In addition, these non-GAAP financial measures are regularly used by investors and analysts to model and track the company’s financial performance. Jazz Pharmaceuticals’ management also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate the company’s business and to make operating decisions, and compensation of executives is based in part on certain of these non-GAAP financial measures. Because these non-GAAP financial measures are important internal measurements for Jazz Pharmaceuticals’ management, the company also believes that these non-GAAP financial measures are useful to investors and analysts since these measures allow for greater transparency with respect to key financial metrics the company uses in assessing its own operating performance and making operating decisions. These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with the company’s condensed consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. 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. Likewise, the company may determine to modify the nature of its adjustments to arrive at its non-GAAP financial measures. 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 have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. “Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995 JAZZ PHARMACEUTICALS PLC CONDENSED CONSOLIDATED STATEMENTS OF INCOME (In thousands, except per share amounts) (Unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 ---- ---- ---- ---- Revenues: Product sales, net $407,971 $371,621 $1,171,304 $1,084,647 Royalties and contract revenues 3,884 2,560 10,990 6,705 ----- ----- ------ ----- Total revenues 411,855 374,181 1,182,294 1,091,352 Operating expenses: Cost of product sales (excluding amortization of intangible assets) 31,203 24,311 84,940 71,730 Selling, general and administrative 124,523 124,368 401,106 375,751 Research and development 47,362 47,796 132,447 118,139 Acquired in-process research and development 75,000 15,000 77,000 23,750 Intangible asset amortization 47,313 26,453 99,164 75,832 Total operating expenses 325,401 237,928 794,657 665,202 ------- ------- ------- ------- Income from operations 86,454 136,253 387,637 426,150 Interest expense, net (19,192) (18,498) (56,330) (42,811) Foreign exchange loss (2,224) (749) (9,115) (1,568) Loss on extinguishment and modification of debt - (638) - (638) --- ---- --- ---- Income before income tax provision and equity in loss of investees 65,038 116,368 322,192 381,133 Income tax provision 1,239 26,437 65,914 100,888 Equity in loss of investees 273 103 637 103 --- --- --- --- Net income $63,526 $89,828 $255,641 $280,142 ======= ======= ======== ======== Net income per ordinary share: Basic $1.06 $1.49 $4.26 $4.62 ===== ===== ===== ===== Diluted $1.03 $1.45 $4.17 $4.51 ===== ===== ===== ===== Weighted-average ordinary shares used in per share calculations - basic 60,108 60,437 60,030 60,692 ====== ====== ====== ====== Weighted-average ordinary shares used in per share calculations - diluted 61,436 61,795 61,360 62,150 ====== ====== ====== ======
JAZZ PHARMACEUTICALS PLC CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) (Unaudited) September 30, December 31, 2017 2016 ---- ---- ASSETS Current assets: Cash and cash equivalents $252,615 $365,963 Investments 200,000 60,000 Accounts receivable, net of allowances 258,616 234,244 Inventories 41,344 34,051 Prepaid expenses 29,249 24,501 Other current assets 49,120 29,310 Total current assets 830,944 748,069 Property and equipment, net 159,386 107,490 Intangible assets, net 3,019,035 3,012,001 Goodwill 941,428 893,810 Deferred tax assets, net, non- current 23,662 15,060 Deferred financing costs 8,149 9,737 Other non-current assets 16,420 14,060 ------ ------ Total assets $4,999,024 $4,800,227 ========== ========== LIABILITIES AND SHAREHOLDERS’ EQUITY Current liabilities: Accounts payable $29,972 $22,415 Accrued liabilities 179,890 193,268 Current portion of long-term debt 36,094 36,094 Income taxes payable 13,603 4,506 Deferred revenue 8,618 1,123 ----- Total current liabilities 268,177 257,406 Deferred revenue, non-current 18,270 2,601 Long-term debt, less current portion 1,543,819 1,993,531 Deferred tax liability, net, non-current 540,964 556,733 Other non-current liabilities 158,497 112,617 Total shareholders’ equity 2,469,297 1,877,339 Total liabilities and shareholders’ equity $4,999,024 $4,800,227 ========== ==========
JAZZ PHARMACEUTICALS PLC SUMMARY OF CASH FLOWS (In thousands) (Unaudited) Nine Months Ended September 30, ------------- 2017 2016 ---- ---- Net cash provided by operating activities $488,528 $411,696 Net cash used in investing activities (237,072) (1,749,296) Net cash provided by (used in) financing activities (369,127) 713,032 Effect of exchange rates on cash and cash equivalents 4,323 2,350 ----- ----- Net decrease in cash and cash equivalents $(113,348) $(622,218) ========= =========
JAZZ PHARMACEUTICALS PLC RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION (In thousands, except per share amounts) (Unaudited) Three Months Ended Nine Months Ended September 30, September 30, ------------- ------------- 2017 2016 2017 2016 ---- ---- ---- ---- GAAP reported net income $63,526 $89,828 $255,641 $280,142 Intangible asset amortization 47,313 26,453 99,164 75,832 Share-based compensation expense 27,126 24,874 79,579 74,490 Upfront and milestone payments 75,000 15,000 75,000 23,750 Transaction and integration related costs - 10,781 - 12,970 Expenses related to certain legal proceedings and restructuring - - 6,000 6,060 Non-cash interest expense 7,855 5,642 19,234 16,418 Loss on extinguishment and modification of debt - 638 - 638 Income tax effect of adjustments (1) (23,171) (12,063) (38,393) (28,775) Non-GAAP adjusted net income $197,649 $161,153 $496,225 $461,525 ======== ======== ======== ======== GAAP reported net income per diluted share $1.03 $1.45 $4.17 $4.51 ===== ===== ===== ===== Non-GAAP adjusted net income per diluted share $3.22 $2.61 $8.09 $7.43 ===== ===== ===== ===== Weighted-average ordinary shares used in diluted per share calculations 61,436 61,795 61,360 62,150 ====== ====== ====== ====== (1) The income tax effect of the adjustments between GAAP reported and non- GAAP adjusted net income takes into account the tax treatment and related tax rate(s) that apply to each adjustment in the applicable tax jurisdiction(s).
JAZZ PHARMACEUTICALS PLC RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION CERTAIN LINE ITEMS AND OTHER INFORMATION (In thousands, except per share amounts and percentages) (Unaudited) Three Months Ended ------------------ September 30, 2017 September 30, 2016 GAAP Adjustments Non-GAAP GAAP Adjustments Non-GAAP Reported Adjusted Reported Adjusted -------- -------- -------- -------- Total revenues $411,855 $ - $411,855 $374,181 $ - $374,181 Cost of product sales (excluding amortization of intangible assets) 31,203 (1,573) (a) 29,630 24,311 (1,348) (a) 22,963 Selling, general and administrative 124,523 (20,903) (b) 103,620 124,368 (29,834) (b) 94,534 Research and development 47,362 (4,650) (c) 42,712 47,796 (4,473) (c) 43,323 Acquired in-process research and development 75,000 (75,000) - 15,000 (15,000) - Intangible asset amortization 47,313 (47,313) - 26,453 (26,453) - Interest expense, net 19,192 (7,855) (d) 11,337 18,498 (5,642) (d) 12,856 Foreign currency loss 2,224 - 2,224 749 - 749 Loss on extinguishment and modification of debt - - - 638 (638) - Income before income tax provision and equity in loss of investees 65,038 157,294 (e) 222,332 116,368 83,388 (e) 199,756 Income tax provision 1,239 23,171 (f) 24,410 26,437 12,063 (f) 38,500 Effective tax rate (g) 1.9% 11.0% 22.7% 19.3% Equity in loss of investees 273 - 273 103 - 103 Net income $63,526 $134,123 (h) $197,649 $89,828 $71,325 (h) $161,153 Net income per diluted share $1.03 $3.22 $1.45 $2.61
JAZZ PHARMACEUTICALS PLC RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION CERTAIN LINE ITEMS AND OTHER INFORMATION (In thousands, except per share amounts and percentages) (Unaudited) Nine Months Ended ----------------- September 30, 2017 September 30, 2016 GAAP Adjustments Non-GAAP GAAP Adjustments Non-GAAP Reported Adjusted Reported Adjusted -------- -------- -------- -------- Total revenues $1,182,294 $ - $1,182,294 $1,091,352 $ - $1,091,352 Cost of product sales (excluding amortization of intangible assets) 84,940 (4,346) (i) 80,594 71,730 (3,110) (i) 68,620 Selling, general and administrative 401,106 (67,582) (j) 333,524 375,751 (79,118) (j) 296,633 Research and development 132,447 (13,651) (k) 118,796 118,139 (11,292) (k) 106,847 Acquired in-process research and development 77,000 (75,000) 2,000 23,750 (23,750) - Intangible asset amortization 99,164 (99,164) - 75,832 (75,832) - Interest expense, net 56,330 (19,234) (d) 37,096 42,811 (16,418) (d) 26,393 Foreign currency loss 9,115 - 9,115 1,568 - 1,568 Loss on extinguishment and modification of debt - - - 638 (638) - Income before income tax provision and equity in loss of investees 322,192 278,977 (l) 601,169 381,133 210,158 (l) 591,291 Income tax provision 65,914 38,393 (f) 104,307 100,888 28,775 (f) 129,663 Effective tax rate (g) 20.5% 17.4% 26.5% 21.9% Equity in loss of investees 637 - 637 103 - 103 Net income $255,641 $240,584 (m) $496,225 $280,142 $181,383 (m) $461,525 Net income per diluted share $4.17 $8.09 $4.51 $7.43 Explanation of Adjustments and Certain Line Items (in thousands): (a) Share-based compensation expense of $1,573 and $1,307 and transaction and integration related costs of $0 and $41 for the three months ended September 30, 2017 and 2016, respectively. (b) Share-based compensation expense of $20,903 and $19,511 and transaction and integration related costs of $0 and $10,323 for the three months ended September 30, 2017 and 2016, respectively. (c) Share-based compensation expense of $4,650 and $4,056 and transaction and integration related costs of $0 and $417 for the three months ended September 30, 2017 and 2016, respectively. (d) Non-cash interest expense associated with debt discount and debt issuance costs for the respective three- and nine-month periods. (e) Sum of adjustments (a) through (d) plus the adjustments for acquired in-process research and development, intangible asset amortization and loss on extinguishment and modification of debt for the respective three-month period. (f) Income tax effect of the adjustments between GAAP reported and non-GAAP adjusted net income takes into account the tax treatment and related tax rate(s) that apply to each adjustment in the applicable tax jurisdiction(s) for the respective three- and nine-month periods. (g) Income tax provision divided by income before income tax provision and equity in loss of investees for the respective three- and nine- month periods. (h) Net of adjustments (e) and (f) for the respective three-month period. (i) Share-based compensation expense of $4,346 and $2,959, expenses related to certain legal proceedings and restructuring of $0 and $110 and transaction and integration related costs of $0 and $41 for the nine months ended September 30, 2017 and 2016, respectively. (j) Share-based compensation expense of $61,582 and $60,664, expenses related to certain legal proceedings and restructuring of $6,000 and $5,950 and transaction and integration related costs of $0 and $12,504 for the nine months ended September 30, 2017 and 2016, respectively. (k) Share-based compensation expense of $13,651 and $10,867 and transaction and integration related costs of $0 and $425 for the nine months ended September 30, 2017 and 2016, respectively. (l) Sum of adjustments (i), (j), (k) and (d) plus the adjustments for acquired in-process research and development, intangible asset amortization and loss on extinguishment and modification of debt, as applicable, for the respective nine-month period. (m) Net of adjustments (l) and (f) for the respective nine-month period.
JAZZ PHARMACEUTICALS PLC RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED 2017 NET INCOME GUIDANCE (In millions, except per share amounts) (Unaudited) GAAP net income $325 - $385 Intangible asset amortization 130 - 165 Share-based compensation expense 95 - 110 Upfront and milestone payments 75 Expenses related to certain legal proceedings and restructuring 6 Non-cash interest expense 30 - 35 Income tax effect of adjustments (50) - (60) Non-GAAP adjusted net income $655 - $685 =========== GAAP net income per diluted share $5.30-$6.30 =========== Non-GAAP adjusted net income per diluted share $10.70-$11.20 ============= Weighted-average ordinary shares used in per share calculations 61
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Company Codes: NASDAQ-NMS:JAZZ |