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Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
(d) | Exhibits |
Exhibit Number | Description |
99.1 | |
104 | 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) |
JAZZ PHARMACEUTICALS PUBLIC LIMITED COMPANY | ||
By: | /s/ Renée Galá | |
Name: | Renée Galá | |
Title: | Executive Vice President and Chief Financial Officer |
• | European rolling launch of Sunosi (initiated May 2020); |
• | U.S. launch of Zepzelca (initiated July 2020); |
• | U.S. launch of Xywav in the fourth quarter of 2020 following the implementation of the risk evaluation and mitigation strategy (REMS); |
• | U.S. launch of JZP-458 (recombinant Erwinia asparaginase) targeted for mid-2021, following a Biologics License Application (BLA) submission and approval; and |
• | U.S. launch of a new indication for Xywav in idiopathic hypersomnia (IH) targeted for late 2021 following a supplemental New Drug Application (sNDA) submission and approval. |
• | In the second quarter of 2020, the company experienced an impact to its business due to reduced patient and healthcare provider interactions, declines in sales representative access to healthcare providers, global government imposed stay-at-home orders, closure of sleep laboratories and treatment centers and the shift to caring for COVID-19 patients. |
• | Throughout the pandemic, the company has leveraged technology and innovation to continue to engage healthcare professionals. The company’s field forces have resumed face-to-face engagement with healthcare providers where possible. |
• | The company's mid- and late-stage clinical trial activity has seen limited impact. The company has taken measures to implement remote and virtual approaches to its clinical trial activities, including remote data monitoring where possible, to maintain patient safety and trial continuity and preserve study integrity. |
• | The company currently expects to have adequate global supply of Xyrem, Sunosi, Defitelio, Vyxeos and Zepzelca for the remainder of 2020, as well as adequate commercial product availability for Xywav to support the planned U.S. launch later this year. |
• | Throughout the pandemic, the company has supported local communities and patient-focused organizations in COVID-19 relief efforts and remains focused on the safety and well-being of its employees. |
• | Xyrem net product sales increased 8% to $446.8 million in the second quarter of 2020 and 9% to $854.7 million in the first half of 2020, compared to the same periods in 2019. |
• | During the quarter, revenue bottle volume growth was 5% and average active patients on therapy grew 3% compared to the second quarter of 2019. |
• | New patient enrollment trended upwards beginning in the latter half of the second quarter following the COVID-19 related decline late in the first quarter of 2020. |
• | In July 2020, the U.S. Food and Drug Administration (FDA) approved the NDA for Xywav, a new differentiated standard of oxybate therapy for the treatment of cataplexy or excessive daytime sleepiness (EDS) in narcolepsy patients 7 years of age and older. |
• | The approval of Xywav is the culmination of nearly a decade of research and development reflecting the company’s ongoing efforts to address the needs of narcolepsy patients. |
• | The company believes Xywav will become the oxybate treatment of choice for patients. |
• | Xywav has 92 percent less sodium than Xyrem, which translates into a reduction of approximately 1,000 to 1,500 milligrams per day for a patient prescribed an oxybate product. |
◦ | The label for Xywav, unlike Xyrem, does not include a warning to prescribers to monitor patients sensitive to sodium intake, including patients with heart failure, hypertension or renal impairment. |
◦ | There is a well-accepted relationship between dietary sodium and blood pressure as well as published hypertension guidelines which underscore the independent association between excessive consumption of sodium and increased risk of stroke, cardiovascular disease and other adverse outcomes. |
• | Multiple and flexible Xywav dosing options are available for adult and pediatric patients and existing Xyrem patients can readily cross over to Xywav at the same dose level. |
• | The joint Xywav and Xyrem REMS implementation is on schedule to support the launch of Xywav in the fourth quarter of 2020. |
• | To ensure timely and broad patient access, Xywav will be priced at parity to Xyrem. |
• | The company expects top-line data in the Xywav Phase 3 pivotal study for the treatment of IH in the fourth quarter of 2020 and submission of a sNDA to FDA as early as the first quarter of 2021. The company is targeting a late 2021 launch. |
• | Sunosi net product sales were $8.6 million in the second quarter of 2020, compared to $1.9 million in the first quarter of 2020. The company launched Sunosi in the U.S. in July 2019. |
• | Net sales in the second quarter of 2020 benefited from lower gross-to-net deductions, and a 12% increase in U.S. prescriptions compared to the first quarter of 2020. Sunosi was approved by the European Medicines Agency (EMA) in January 2020 and launched in Germany in May 2020. |
• | At the end of the second quarter, approximately 85% of commercially insured U.S. patients had access to coverage for Sunosi. |
• | JZP-385, a highly selective modulator of T-type calcium channels, is in clinical development for the potential treatment of essential tremor. |
• | The company is initiating a new healthy volunteer study in August 2020 to evaluate a modified release formulation. |
• | Study start-up activities will begin later this year to enable initiation of a Phase 2b study in early 2021. |
• | In June 2020, Zepzelca received accelerated approval by FDA for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. |
• | In July 2020, the company launched Zepzelca in the U.S. and the National Comprehensive Cancer Network (NCCN) added Zepzelca to the Clinical Practice Guidelines in Oncology for SCLC as a preferred treatment in patients who relapse in six months or less after prior systemic therapy and as a recommended regimen in patients who relapse more than six months after prior systemic therapy. |
• | All contracts with distributors and GPOs were in place at launch. |
• | The company is experiencing strong initial physician reception and uptake of Zepzelca across academic and community accounts and the sales force is actively engaging with target prescribers through live and virtual interactions. |
• | Erwinaze/Erwinase net product sales increased by $5.1 million to $32.7 million in the second quarter of 2020 compared to the same period in 2019. |
• | Erwinaze availability continues to be impacted by ongoing supply and manufacturing issues at the owner and sole manufacturer of the product, Porton Biopharma Limited (PBL), and the company continues to expect inter-quarter variability in Erwinaze net product sales due to timing and availability of supply. |
• | The company’s current agreement with PBL will terminate on December 31, 2020. The company has the right to sell certain Erwinaze inventory post-termination and expects to distribute available Erwinaze supply through the first half of 2021. |
• | The company continues to progress development of JZP-458 to ensure that acute lymphoblastic leukemia patients have access to a reliable, high-quality recombinant product. |
• | The pivotal Phase 2/3 study is continuing, with nearly all planned clinical sites activated and patient enrollment progressing well. |
• | The company expects to submit a BLA as early as year-end, with an objective of launching in the U.S. in mid-2021. |
• | Defitelio/defibrotide net product sales decreased 7% to $42.7 million in the second quarter of 2020 compared to the same period in 2019. During the second quarter of 2020, demand was impacted by a reduction in the number of hematopoietic stem cell transplants performed due to COVID-19. The company observed a recovery in demand towards the end of the second quarter. |
• | The company expects top-line results from the Phase 2 proof-of-concept study for prevention of acute graft-versus-host disease in late 2020. |
• | Vyxeos net product sales decreased 15% to $26.6 million in the second quarter of 2020 compared to the same period in 2019. During the second quarter of 2020, Vyxeos sales were impacted by COVID-19 treatment recommendations to opt for oral or less intensive outpatient therapies for cancer patients. The company observed a recovery in demand late in the second quarter, particularly as hospitals adopted procedures to accommodate the care of non-COVID-19 patients. |
• | At the American Society of Clinical Oncology Annual Meeting in May, the 5-year overall survival data from the Phase 3 pivotal study demonstrated that improved survival with Vyxeos was maintained in the overall study population. These data support prior evidence that Vyxeos has the ability to contribute to durable remissions in older patients with newly diagnosed high-risk/secondary acute myeloid leukemia. |
• | In June 2020, following FDA approval of Zepzelca, the company made a milestone payment of $100.0 million to Pharma Mar, S.A. (PharmaMar) in accordance with its exclusive U.S. license agreement. The company capitalized the payment, resulting in an increase in intangible assets. |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
(In thousands, except per share amounts) | 2020 | 2019 | 2020 | 2019 | |||||||||||
Total revenues | $ | 562,436 | $ | 534,133 | $ | 1,097,162 | $ | 1,042,319 | |||||||
GAAP net income (loss) | $ | 114,801 | $ | 261,898 | $ | (43,032 | ) | $ | 347,099 | ||||||
Adjusted net income1 | $ | 207,316 | $ | 232,537 | $ | 233,149 | $ | 396,710 | |||||||
GAAP EPS | $ | 2.06 | $ | 4.56 | $ | (0.77 | ) | $ | 6.01 | ||||||
Adjusted EPS1 | $ | 3.71 | $ | 4.05 | $ | 4.14 | $ | 6.87 |
1. | Commencing in 2020, following consultation with the staff of the Division of Corporation Finance of the U.S. Securities and Exchange Commission, the company no longer excludes upfront and milestone payments from the company’s non-GAAP adjusted net income, its line item components and non-GAAP adjusted EPS. For purposes of comparability, non-GAAP adjusted financial measures for the six months ended June 30, 2019 have been updated to reflect this change. See “Non-GAAP Financial Measures” below. |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
(In thousands) | 2020 | 2019 | 2020 | 2019 | |||||||||||
Xyrem® (sodium oxybate) oral solution | $ | 446,808 | $ | 413,212 | $ | 854,683 | $ | 781,529 | |||||||
Defitelio® (defibrotide sodium) / defibrotide | 42,714 | 46,055 | 90,146 | 87,555 | |||||||||||
Erwinaze® / Erwinase® (asparaginase Erwinia chrysanthemi) | 32,683 | 27,622 | 70,415 | 88,521 | |||||||||||
Vyxeos® (daunorubicin and cytarabine) liposome for injection | 26,568 | 31,362 | 59,288 | 60,305 | |||||||||||
Sunosi® (solriamfetol) | 8,578 | — | 10,502 | — | |||||||||||
Other | 852 | 5,172 | 3,374 | 8,844 | |||||||||||
Product sales, net | 558,203 | 523,423 | 1,088,408 | 1,026,754 | |||||||||||
Royalties and contract revenues | 4,233 | 10,710 | 8,754 | 15,565 | |||||||||||
Total revenues | $ | 562,436 | $ | 534,133 | $ | 1,097,162 | $ | 1,042,319 |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
(In thousands, except percentages) | 2020 | 2019 | 2020 | 2019 | |||||||||||
GAAP: | |||||||||||||||
Cost of product sales | $ | 28,008 | $ | 27,676 | $ | 56,665 | $ | 61,182 | |||||||
Gross margin | 95.0 | % | 94.7 | % | 94.8 | % | 94.0 | % | |||||||
Selling, general and administrative | $ | 191,406 | $ | 176,014 | $ | 399,806 | $ | 343,961 | |||||||
% of total revenues | 34.0 | % | 33.0 | % | 36.4 | % | 33.0 | % | |||||||
Research and development | $ | 78,922 | $ | 62,384 | $ | 165,029 | $ | 122,489 | |||||||
% of total revenues | 14.0 | % | 11.7 | % | 15.0 | % | 11.8 | % | |||||||
Acquired in-process research and development | $ | 3,000 | $ | 2,200 | $ | 205,250 | $ | 58,200 | |||||||
Impairment charge | $ | — | $ | — | $ | 136,139 | $ | — | |||||||
Income tax provision (benefit) | $ | 54,754 | $ | (78,650 | ) | $ | 3,467 | $ | (49,534 | ) | |||||
Effective tax rate | 31.9 | % | (42.7 | )% | (9.2 | )% | (16.5 | )% |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
(In thousands, except percentages) | 2020 | 2019 | 2020 | 2019 | |||||||||||
Non-GAAP adjusted: | |||||||||||||||
Cost of product sales | $ | 26,087 | $ | 25,968 | $ | 53,071 | $ | 57,815 | |||||||
Gross margin | 95.3 | % | 95.0 | % | 95.1 | % | 94.4 | % | |||||||
Selling, general and administrative | $ | 170,386 | $ | 155,329 | $ | 358,190 | $ | 302,906 | |||||||
% of total revenues | 30.3 | % | 29.1 | % | 32.6 | % | 29.1 | % | |||||||
Research and development | $ | 71,259 | $ | 56,488 | $ | 150,981 | $ | 111,070 | |||||||
% of total revenues | 12.7 | % | 10.6 | % | 13.8 | % | 10.7 | % | |||||||
Acquired in-process research and development | $ | 3,000 | $ | 2,200 | $ | 205,250 | $ | 58,200 | |||||||
Income tax provision | $ | 73,085 | $ | 52,027 | $ | 77,772 | $ | 97,741 | |||||||
Effective tax rate | 25.9 | % | 18.2 | % | 24.9 | % | 19.7 | % |
• | Selling, general and administrative (SG&A) expenses increased in the second quarter of 2020 compared to the same period in 2019 on a GAAP and on a non-GAAP adjusted basis due to increased investment in sales, marketing and launch activities related to the company's priority products and product candidates, as well as an increase in other expenses related to the expansion of the company's business. |
• | Research and development (R&D) expenses increased in the second quarter of 2020 compared to the same period in 2019 on a GAAP and on a non-GAAP adjusted basis primarily due to the pivotal JZP-458 study, as well as expenses related to progress made on the company's other clinical and pre-clinical development programs. |
• | On a GAAP basis, in the second quarter of 2019, the company recorded a one-time tax benefit of $112.3 million, or $1.96 per diluted share, resulting from an intra-entity intellectual property asset transfer. The increase in the effective tax rate in the second quarter of 2020 compared to the same period in 2019 was primarily due to the impact of the intra-entity intellectual property asset transfer. Excluding this effect, the increase in the effective tax rate for the second quarter of 2020 compared to the same period in 2019 was primarily due to the impact of the disallowance of certain interest deductions, and provision for a proposed settlement reached with the French tax authorities in respect of an ongoing tax audit. |
• | On a non-GAAP basis, the increase in the effective tax rate in the second quarter of 2020 compared to the same period in 2019 was primarily due to the impact of the disallowance of certain interest deductions, and provision for a proposed settlement reached with the French tax authorities in respect of an ongoing tax audit. |
(in millions) | Guidance provided as of | |
May 5, 2020 | August 4, 2020 | |
Revenues | $2,120 - $2,260 | $2,225 - $2,325 |
Total net product sales | $2,105 - $2,240 | $2,210 - $2,310 |
-Neuroscience | $1,650 - $1,740 | $1,725 - $1,800 |
-Oncology | $420 - $510 | $445 - $525 |
(in millions, except per share amounts and percentages) | Guidance provided as of | |
May 5, 2020 | August 4, 2020 | |
Gross margin % | 94% | 94% |
SG&A expenses | $785 - $843 | $785 - $843 |
SG&A expenses as % of total revenues | 35% - 40% | 34% - 38% |
R&D Expenses | $277 - $313 | $302 - $338 |
R&D expenses as % of total revenues | 12% - 15% | 13% - 15% |
Acquired in-process research and development expenses | $202 | $205 |
Impairment charge | $136 | $136 |
Effective tax rate | 22% - 29% | 19% - 26% |
Net income per diluted share | $2.70 - $4.30 | $3.40 - $4.85 |
(in millions, except per share amounts and percentages) | Guidance provided as of | |
May 5, 2020 | August 4, 2020 | |
Gross margin % | 94%1,6 | 94%1,6 |
SG&A expenses | $700 - $7502,6 | $700 - $7502,6 |
SG&A expenses as % of total revenues | 31% - 35% | 30% - 34% |
R&D Expenses | $250 - $2803,6 | $275 - $3053,6 |
R&D expenses as % of total revenues | 11% - 13% | 12% - 14% |
Acquired in-process research and development expenses | $2024 | $2054 |
Effective tax rate | 20% - 23%5,6 | 19% - 22%5,6 |
Net income per diluted share | $11.25 - $12.504,6 | $11.90 - $13.004,6 |
1. | Excludes $8-$9 million of share-based compensation expense from estimated GAAP gross margin. |
2. | Excludes $85-$93 million of share-based compensation expense from estimated GAAP SG&A expenses. |
3. | Excludes $27-$33 million of share-based compensation expense from estimated GAAP R&D expenses. |
4. | Commencing in 2020, the company no longer excludes upfront and milestone payments from the company’s non-GAAP adjusted net income, its line item components and non-GAAP adjusted EPS. The impact of this change to the company’s 2020 non-GAAP adjusted net income and non-GAAP adjusted EPS guidance is approximately $175 million or $3.13 per diluted share, respectively, primarily related to the post-tax impact of the $200 million upfront payment made to PharmaMar in January 2020. |
5. | Excludes the income tax effect of adjustments between GAAP reported and non-GAAP adjusted net income. |
6. | 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 2020 Net Income Guidance" at the end of this press release. |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||||||
Revenues: | |||||||||||||||
Product sales, net | $ | 558,203 | $ | 523,423 | $ | 1,088,408 | $ | 1,026,754 | |||||||
Royalties and contract revenues | 4,233 | 10,710 | 8,754 | 15,565 | |||||||||||
Total revenues | 562,436 | 534,133 | 1,097,162 | 1,042,319 | |||||||||||
Operating expenses: | |||||||||||||||
Cost of product sales (excluding amortization of acquired developed technologies) | 28,008 | 27,676 | 56,665 | 61,182 | |||||||||||
Selling, general and administrative | 191,406 | 176,014 | 399,806 | 343,961 | |||||||||||
Research and development | 78,922 | 62,384 | 165,029 | 122,489 | |||||||||||
Intangible asset amortization | 62,974 | 61,576 | 125,821 | 118,461 | |||||||||||
Acquired in-process research and development | 3,000 | 2,200 | 205,250 | 58,200 | |||||||||||
Impairment charge | — | — | 136,139 | — | |||||||||||
Total operating expenses | 364,310 | 329,850 | 1,088,710 | 704,293 | |||||||||||
Income from operations | 198,126 | 204,283 | 8,452 | 338,026 | |||||||||||
Interest expense, net | (26,210 | ) | (18,234 | ) | (44,706 | ) | (36,156 | ) | |||||||
Foreign exchange loss | (464 | ) | (1,933 | ) | (1,596 | ) | (2,544 | ) | |||||||
Income (loss) before income tax provision (benefit) and equity in loss of investees | 171,452 | 184,116 | (37,850 | ) | 299,326 | ||||||||||
Income tax provision (benefit) | 54,754 | (78,650 | ) | 3,467 | (49,534 | ) | |||||||||
Equity in loss of investees | 1,897 | 868 | 1,715 | 1,761 | |||||||||||
Net income (loss) | $ | 114,801 | $ | 261,898 | $ | (43,032 | ) | $ | 347,099 | ||||||
Net income (loss) per ordinary share: | |||||||||||||||
Basic | $ | 2.07 | $ | 4.62 | $ | (0.77 | ) | $ | 6.09 | ||||||
Diluted | $ | 2.06 | $ | 4.56 | $ | (0.77 | ) | $ | 6.01 | ||||||
Weighted-average ordinary shares used in per share calculations - basic | 55,413 | 56,707 | 55,684 | 56,955 | |||||||||||
Weighted-average ordinary shares used in per share calculations - diluted | 55,864 | 57,427 | 55,684 | 57,753 |
June 30, 2020 | December 31, 2019 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 786,082 | $ | 637,344 | |||
Investments | 910,000 | 440,000 | |||||
Accounts receivable, net of allowances | 351,920 | 355,987 | |||||
Inventories | 92,534 | 78,608 | |||||
Prepaid expenses | 49,109 | 39,434 | |||||
Other current assets | 112,701 | 78,895 | |||||
Total current assets | 2,302,346 | 1,630,268 | |||||
Property, plant and equipment, net | 128,259 | 131,506 | |||||
Operating lease assets | 133,179 | 139,385 | |||||
Intangible assets, net | 2,286,126 | 2,440,977 | |||||
Goodwill | 918,021 | 920,018 | |||||
Deferred tax assets, net | 243,395 | 221,403 | |||||
Deferred financing costs | 6,347 | 7,426 | |||||
Other non-current assets | 48,828 | 47,914 | |||||
Total assets | $ | 6,066,501 | $ | 5,538,897 | |||
LIABILITIES AND SHAREHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 50,043 | $ | 45,732 | |||
Accrued liabilities | 266,918 | 269,686 | |||||
Current portion of long-term debt | 33,387 | 33,387 | |||||
Income taxes payable | 55,979 | 10,965 | |||||
Deferred revenue | 3,633 | 4,720 | |||||
Total current liabilities | 409,960 | 364,490 | |||||
Deferred revenue, non-current | 3,588 | 4,861 | |||||
Long-term debt, less current portion | 2,069,669 | 1,573,870 | |||||
Operating lease liabilities, less current portion | 144,264 | 151,226 | |||||
Deferred tax liabilities, net | 162,376 | 224,095 | |||||
Other non-current liabilities | 134,839 | 109,374 | |||||
Total shareholders’ equity | 3,141,805 | 3,110,981 | |||||
Total liabilities and shareholders’ equity | $ | 6,066,501 | $ | 5,538,897 |
Six Months Ended June 30, | |||||||
2020 | 2019 | ||||||
Net cash provided by operating activities | $ | 455,488 | $ | 351,100 | |||
Net cash provided by (used in) investing activities | (801,245 | ) | 163,414 | ||||
Net cash provided by (used in) financing activities | 494,851 | (186,502 | ) | ||||
Effect of exchange rates on cash and cash equivalents | (356 | ) | 105 | ||||
Net increase in cash and cash equivalents | $ | 148,738 | $ | 328,117 |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||||||
GAAP reported net income (loss) | $ | 114,801 | $ | 261,898 | $ | (43,032 | ) | $ | 347,099 | ||||||
Intangible asset amortization | 62,974 | 61,576 | 125,821 | 118,461 | |||||||||||
Share-based compensation expense | 30,604 | 28,289 | 59,258 | 55,841 | |||||||||||
Impairment charge (a) | — | — | 136,139 | — | |||||||||||
Non-cash interest expense (b) | 12,793 | 11,451 | 24,793 | 22,584 | |||||||||||
Loss on extinguishment of debt | 4,475 | — | 4,475 | — | |||||||||||
Income tax effect of above adjustments | (18,331 | ) | (18,403 | ) | (74,305 | ) | (35,001 | ) | |||||||
Income tax benefit related to intra-entity intellectual property asset transfer | — | (112,274 | ) | — | (112,274 | ) | |||||||||
Non-GAAP adjusted net income | $ | 207,316 | $ | 232,537 | $ | 233,149 | $ | 396,710 | |||||||
GAAP reported net income (loss) per diluted share | $ | 2.06 | $ | 4.56 | $ | (0.77 | ) | $ | 6.01 | ||||||
Non-GAAP adjusted net income per diluted share | $ | 3.71 | $ | 4.05 | $ | 4.14 | $ | 6.87 | |||||||
Weighted-average ordinary shares used in diluted per share calculations - GAAP | 55,864 | 57,427 | 55,684 | 57,753 | |||||||||||
Weighted-average ordinary shares used in diluted per share calculations - non-GAAP | 55,864 | 57,427 | 56,328 | 57,753 |
(a) | Impairment charge related to the company's decision to stop enrollment in its Phase 3 clinical study of defibrotide for the prevention of veno-occlusive disease due to a determination by an Independent Data Monitoring Committee that it is highly unlikely that the study will reach its primary endpoint. |
(b) | Non-cash interest expense associated with debt discount and debt issuance costs. |
Three months ended June 30, 2020 | |||||||||||||||||||||||||||||
Cost of product sales | Gross margin | Selling, general and administrative | Research and development | Intangible asset amortization | Interest expense, net | Income tax provision | Effective tax rate | ||||||||||||||||||||||
GAAP Reported | $ | 28,008 | 95.0 | % | $ | 191,406 | $ | 78,922 | $ | 62,974 | $ | 26,210 | $ | 54,754 | 31.9 | % | |||||||||||||
Non-GAAP Adjustments: | |||||||||||||||||||||||||||||
Intangible asset amortization | — | — | — | — | (62,974 | ) | — | — | — | ||||||||||||||||||||
Share-based compensation expense | (1,921 | ) | 0.3 | (21,020 | ) | (7,663 | ) | — | — | — | — | ||||||||||||||||||
Non-cash interest expense | — | — | — | — | — | (12,793 | ) | — | — | ||||||||||||||||||||
Loss on extinguishment of debt | — | — | — | — | — | (4,475 | ) | — | — | ||||||||||||||||||||
Income tax effect of above adjustments | — | — | — | — | — | — | 18,331 | (6.0 | ) | ||||||||||||||||||||
Total of Non-GAAP adjustments | (1,921 | ) | 0.3 | (21,020 | ) | (7,663 | ) | (62,974 | ) | (17,268 | ) | 18,331 | (6.0 | ) | |||||||||||||||
Non-GAAP Adjusted | $ | 26,087 | 95.3 | % | $ | 170,386 | $ | 71,259 | $ | — | $ | 8,942 | $ | 73,085 | 25.9 | % |
Three months ended June 30, 2019 | |||||||||||||||||||||||||||||
Cost of product sales | Gross margin | Selling, general and administrative | Research and development | Intangible asset amortization | Interest expense, net | Income tax provision (benefit) | Effective tax rate | ||||||||||||||||||||||
GAAP Reported | $ | 27,676 | 94.7 | % | $ | 176,014 | $ | 62,384 | $ | 61,576 | $ | 18,234 | $ | (78,650 | ) | (42.7 | )% | ||||||||||||
Non-GAAP Adjustments: | |||||||||||||||||||||||||||||
Intangible asset amortization | — | — | — | — | (61,576 | ) | — | — | — | ||||||||||||||||||||
Share-based compensation expense | (1,708 | ) | 0.3 | (20,685 | ) | (5,896 | ) | — | — | — | — | ||||||||||||||||||
Non-cash interest expense | — | — | — | — | — | (11,451 | ) | — | — | ||||||||||||||||||||
Income tax effect of above adjustments | — | — | — | — | — | — | 18,403 | (0.1 | ) | ||||||||||||||||||||
Income tax benefit related to intra-entity intellectual property asset transfer | — | — | — | — | — | — | 112,274 | 61.0 | |||||||||||||||||||||
Total of Non-GAAP adjustments | (1,708 | ) | 0.3 | (20,685 | ) | (5,896 | ) | (61,576 | ) | (11,451 | ) | 130,677 | 60.9 | ||||||||||||||||
Non-GAAP Adjusted | $ | 25,968 | 95.0 | % | $ | 155,329 | $ | 56,488 | $ | — | $ | 6,783 | $ | 52,027 | 18.2 | % |
Six months ended June 30, 2020 | |||||||||||||||||||||||||||||||||
Cost of product sales | Gross margin | Selling, general and administrative | Research and development | Intangible asset amortization | Impairment charge | Interest expense, net | Income tax provision | Effective tax rate | |||||||||||||||||||||||||
GAAP Reported | $ | 56,665 | 94.8 | % | $ | 399,806 | $ | 165,029 | $ | 125,821 | $ | 136,139 | $ | 44,706 | $ | 3,467 | (9.2 | )% | |||||||||||||||
Non-GAAP Adjustments: | |||||||||||||||||||||||||||||||||
Intangible asset amortization | — | — | — | — | (125,821 | ) | — | — | — | — | |||||||||||||||||||||||
Share-based compensation expense | (3,594 | ) | 0.3 | (41,616 | ) | (14,048 | ) | — | — | — | — | — | |||||||||||||||||||||
Impairment charges | — | — | — | — | — | (136,139 | ) | — | — | — | |||||||||||||||||||||||
Non-cash interest expense | — | — | — | — | — | — | (24,793 | ) | — | — | |||||||||||||||||||||||
Loss on extinguishment of debt | — | — | — | — | — | — | (4,475 | ) | — | — | |||||||||||||||||||||||
Income tax effect of above adjustments | — | — | — | — | — | — | — | 74,305 | 34.1 | ||||||||||||||||||||||||
Total of Non-GAAP adjustments | (3,594 | ) | 0.3 | (41,616 | ) | (14,048 | ) | (125,821 | ) | (136,139 | ) | (29,268 | ) | 74,305 | 34.1 | ||||||||||||||||||
Non-GAAP Adjusted | $ | 53,071 | 95.1 | % | $ | 358,190 | $ | 150,981 | $ | — | $ | — | $ | 15,438 | $ | 77,772 | 24.9 | % |
Six months ended June 30, 2019 | |||||||||||||||||||||||||||||
Cost of product sales | Gross margin | Selling, general and administrative | Research and development | Intangible asset amortization | Interest expense, net | Income tax provision (benefit) | Effective tax rate | ||||||||||||||||||||||
GAAP Reported | $ | 61,182 | 94.0 | % | $ | 343,961 | $ | 122,489 | $ | 118,461 | $ | 36,156 | $ | (49,534 | ) | (16.5 | )% | ||||||||||||
Non-GAAP Adjustments: | |||||||||||||||||||||||||||||
Intangible asset amortization | — | — | — | — | (118,461 | ) | — | — | — | ||||||||||||||||||||
Share-based compensation expense | (3,367 | ) | 0.4 | (41,055 | ) | (11,419 | ) | — | — | — | — | ||||||||||||||||||
Non-cash interest expense | — | — | — | — | — | (22,584 | ) | — | — | ||||||||||||||||||||
Income tax effect of above adjustments | — | — | — | — | — | — | 35,001 | (1.3 | ) | ||||||||||||||||||||
Income tax benefit related to intra-entity intellectual property asset transfer | — | — | — | — | — | — | 112,274 | 37.5 | |||||||||||||||||||||
Total of Non-GAAP adjustments | (3,367 | ) | 0.4 | (41,055 | ) | (11,419 | ) | (118,461 | ) | (22,584 | ) | 147,275 | 36.2 | ||||||||||||||||
Non-GAAP Adjusted | $ | 57,815 | 94.4 | % | $ | 302,906 | $ | 111,070 | $ | — | $ | 13,572 | $ | 97,741 | 19.7 | % |
GAAP net income | $190 - $270 |
Intangible asset amortization | 250 - 270 |
Share-based compensation expense | 120 -135 |
Impairment charge | 136 |
Loss on extinguishment of debt | 4 |
Non-cash interest expense | 50 - 60 |
Income tax effect of adjustments | (105) - (115) |
Non-GAAP adjusted net income | $670 - $730 |
GAAP net income per diluted share | $3.40 - $4.85 |
Non-GAAP adjusted net income per diluted share | $11.90 - $13.00 |
Weighted-average ordinary shares used in per share calculations | 56 |