Jazz Pharmaceuticals Announces Second Quarter 2021 Financial Results
"As we enter what we expect to be a period of sustained growth, I have never been more excited about the future for Jazz. The recent approval and launches of Xywav and Rylaze exemplify Jazz today. We are rapidly establishing ourselves as an innovative biopharmaceutical company with expanding R&D capabilities and substantial commercial prowess, underscored by our consistent execution across the business. The addition of the GW cannabinoid platform and related pipeline complement and enhance our own growing R&D capabilities, accelerating our ability to improve the lives of patients," said
Business Updates
Corporate Development
On
Neuroscience
Oxybate (Xyrem® and Xywav):
- Net product sales for the combined oxybate business increased 3% to
$458 .3 million in the second quarter of 2021 compared to the same period in 2020. - Average active oxybate patients on therapy were approximately 15,900 in the second quarter of 2021, an increase of approximately 5% compared to the same period in 2020.
Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
- Xywav net product sales were
$124 .2 million in the second quarter of 2021. - There were approximately 5,100 active patients on Xywav exiting the second quarter of 2021.
- In
June 2021 , FDA recognized seven years of Orphan Drug Exclusivity for Xywav. - FDA published its summary of clinical superiority findings for Xywav stating that Xywav is clinically superior to Xyrem by means of greater safety because Xywav provides a greatly reduced chronic sodium burden compared to Xyrem, and that the differences in the sodium content of the two products at the recommended doses will be clinically meaningful in reducing cardiovascular morbidity in a substantial proportion of patients for whom the drug is indicated.
- The Company has achieved its goal of obtaining broad payer coverage, having entered into agreements with all three of the largest pharmacy benefit managers.
Xyrem (sodium oxybate) oral solution:
- Xyrem net product sales decreased 25% to
$334 .2 million in the second quarter of 2021 compared to the same period in 2020.
Xywav in Idiopathic Hypersomnia
- FDA has granted Priority Review Designation and accepted the supplemental New Drug Application (sNDA) for Xywav in adult patients with idiopathic hypersomnia (IH). The Prescription Drug Fee User Act (PDUFA) target date for an FDA decision has been set for
August 12, 2021 , which is in line with the Company's objective of launching in the fourth quarter of 2021 following risk evaluation and mitigation strategy (REMS) implementation.
Epidiolex/Epidyolex® (cannabidiol):
- Epidiolex/Epidyolex net product sales were
$109.5 million in the second quarter of 2021. This includes sales fromMay 5, 2021 , the closing date of theGW Acquisition . - On an unaudited pro forma basis, net product sales in the second quarter of 2021 increased by 32% to
$155.9 million compared to the same period in 2020. - The Company expects to initiate a Phase 3 pivotal trial of Epidiolex for Epilepsy with Myoclonic-Atonic Seizures (EMAS), also known as Doose syndrome, in the first half of 2022. EMAS represents the fourth target indication for Epidiolex.
Sunosi® (solriamfetol):
- Sunosi net product sales increased by 41% to
$12 .1 million in the second quarter of 2021 compared to the same period of 2020. - In the second quarter of 2021,
U.S. prescriptions increased by 25% compared to the first quarter of 2021.
Nabiximols:
- The Company expects to initiate the third Phase 3 nabiximols clinical trial in multiple sclerosis (MS)-related spasticity this year.
- The two ongoing Phase 3 clinical trials in MS-related spasticity continue to progress.
JZP385:
- JZP385, a highly selective modulator of T-type calcium channels, is in clinical development for the potential treatment of essential tremor.
- The Company expects to initiate a Phase 2b trial in late 2021.
JZP150:
- JZP150, a fatty acid amide hydrolase (FAAH) inhibitor, is in clinical development for the potential treatment of post-traumatic stress disorder.
- The Company expects to initiate a Phase 2 trial in late 2021.
Oncology
Zepzelca™ (lurbinectedin):
- Zepzelca net product sales were
$55.9 million in the second quarter of 2021. - Sequential demand growth over the first two quarters of 2021 was 8% and 9% respectively, offset mainly by reduced inventory holding by distributors.
- Robust Zepzelca development program planned:
- The Company's partner, PharmaMar, plans to initiate a confirmatory trial in second-line small cell lung cancer (SCLC) later this year. If positive, this trial would confirm the benefit of Zepzelca in the treatment of SCLC when patients progress following first-line treatment with a platinum-based regimen.
- The Company is collaborating with Roche to initiate a Phase 3 pivotal clinical trial in first-line extensive stage SCLC in combination with immunotherapy this year.
- The Company expects to initiate a Phase 2 basket trial in early 2022 to explore lurbinectedin monotherapy in patients with select advanced or metastatic solid tumors. Cohorts will include advanced urothelial cancer, large cell neuroendocrine tumor of the lung, and homologous recombinant deficient positive (HRD+) cancers.
- The Company has initiated a Phase 4 observational study to collect real world safety and outcome data in adult Zepzelca monotherapy patients with extensive stage small cell lung cancer who progress on or after prior platinum-containing chemotherapy.
Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn):
- On
June 30, 2021 , FDA approved Rylaze under the Real-Time Oncology Review program for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in pediatric patients one month and older and adult patients who have developed hypersensitivity to E. coli-derived asparaginase. - Rylaze was launched and commercially available in the
U.S. onJuly 15, 2021 . - Rylaze is the only recombinant Erwinia asparaginase manufactured product that maintains a clinically meaningful level of asparaginase activity throughout the entire duration of treatment. It was developed by Jazz to address the needs of patients and healthcare providers for an innovative, high-quality Erwinia asparaginase with reliable supply.
- Rylaze was granted orphan drug designation for the treatment of ALL/LBL by FDA in
June 2021 . - The Company will continue to work with FDA and plans to submit additional data in support of a Monday/Wednesday/Friday dosing schedule. Part B of the study is evaluating intravenous administration and is ongoing. The company also plans to submit this data for presentation at a future medical meeting.
- The Company anticipates that data from the current development program will support regulatory filings in
Europe in 2022 and is currently working with an in-country partner to advance the program for filing, approval and launch inJapan .
Vyxeos® (daunorubicin and cytarabine) liposome for injection:
- Vyxeos net product sales increased 18% to
$31 .5 million in the second quarter of 2021 compared to the same period in 2020.
Defitelio® (defibrotide sodium) / defibrotide:
- Defitelio/defibrotide net product sales increased 13% to
$48 .1 million in the second quarter of 2021 compared to the same period in 2020.
Erwinaze® / Erwinase® (asparaginase Erwinia chrysanthemi):
- Erwinaze/Erwinase net product sales decreased 13% to
$28.3 million in the second quarter of 2021 compared to the same period in 2020. - The Company's agreement with
Porton Biopharma Limited terminated onDecember 31, 2020 . The Company had the right to sell certain Erwinaze inventory post-termination. Sale of this inventory was completed inJune 2021 .
Financial Highlights
Three Months Ended |
Six Months Ended |
||||||||||||||
(In thousands, except per share amounts) |
2021 |
2020 |
2021 |
2020 |
|||||||||||
Total revenues |
$ |
751,811 |
$ |
562,436 |
$ |
1,359,392 |
$ |
1,097,162 |
|||||||
GAAP net income (loss) |
$ |
(363,316) |
$ |
114,801 |
$ |
(241,484) |
$ |
(43,032) |
|||||||
Adjusted net income1 |
$ |
240,575 |
$ |
207,316 |
$ |
469,394 |
$ |
233,149 |
|||||||
GAAP EPS |
$ |
(6.11) |
$ |
2.06 |
$ |
(4.17) |
$ |
(0.77) |
|||||||
Adjusted EPS1 |
$ |
3.90 |
$ |
3.71 |
$ |
7.82 |
$ |
4.14 |
________________________
1. |
Commencing in 2020, following consultation with the staff of the |
GAAP net income (loss) for the second quarter of 2021 was (
Non-GAAP adjusted net income for the second quarter of 2021 was
Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.
Total Revenues
Three Months Ended |
Six Months Ended |
||||||||||||||
(In thousands) |
2021 |
2020 |
2021 |
2020 |
|||||||||||
Xyrem |
$ |
334,182 |
$ |
446,808 |
$ |
669,732 |
$ |
854,683 |
|||||||
Xywav |
124,164 |
— |
199,580 |
— |
|||||||||||
Total Oxybate |
458,346 |
446,808 |
869,312 |
854,683 |
|||||||||||
Epidiolex/Epidyolex1 |
109,481 |
— |
109,481 |
— |
|||||||||||
Sunosi |
12,124 |
8,578 |
23,730 |
10,502 |
|||||||||||
Sativex® (delta-9-tetrahydrocannabiol and cannabidiol)1 |
1,961 |
— |
1,961 |
— |
|||||||||||
Total Neuroscience |
581,912 |
455,386 |
1,004,484 |
865,185 |
|||||||||||
Zepzelca |
55,924 |
— |
110,258 |
— |
|||||||||||
Vyxeos |
31,453 |
26,568 |
64,608 |
59,288 |
|||||||||||
Defitelio/defibrotide |
48,096 |
42,714 |
97,715 |
90,146 |
|||||||||||
Erwinaze/Erwinase |
28,314 |
32,683 |
69,382 |
70,415 |
|||||||||||
Total Oncology |
163,787 |
101,965 |
341,963 |
219,849 |
|||||||||||
Other |
2,641 |
852 |
5,424 |
3,374 |
|||||||||||
Product sales, net |
748,340 |
558,203 |
1,351,871 |
1,088,408 |
|||||||||||
Royalties and contract revenues |
3,471 |
4,233 |
7,521 |
8,754 |
|||||||||||
Total revenues |
$ |
751,811 |
$ |
562,436 |
$ |
1,359,392 |
$ |
1,097,162 |
__________________________
1. |
Net product sales for Epidiolex and Sativex are included from the closing of the |
Total revenues increased 34% in the second quarter of 2021 compared to the same period in 2020.
- Products launched or acquired since 2019 accounted for 41% of total net product sales in the second quarter of 2021.
- Neuroscience net product sales in the second quarter of 2021 increased 28% to
$581 .9 million compared to the same period in 2020. Oxybate net product sales increased to$458.3 million led by strong Xywav net product sales of$124.2 million partially offset by a decrease in Xyrem net product sales as a result of the strong adoption of Xywav by existing Xyrem patients. Epidiolex/Epidyolex net product sales from the date of acquisition were$109.5 million . - Oncology net product sales in the second quarter of 2021 increased 61% to
$163 .8 million compared to the same period in 2020 primarily driven by robust Zepzelca net product sales of$55 .9 million. Zepzelca launched in theU.S. inJuly 2020 .
Operating Expenses and Effective Tax Rate
Three Months Ended |
Six Months Ended |
||||||||||||||
(In thousands, except percentages) |
2021 |
2020 |
2021 |
2020 |
|||||||||||
GAAP: |
|||||||||||||||
Cost of product sales |
$ |
119,194 |
$ |
28,008 |
$ |
159,383 |
$ |
56,665 |
|||||||
Gross margin |
84.1% |
95.0% |
88.2% |
94.8% |
|||||||||||
Selling, general and administrative |
$ |
429,031 |
$ |
191,406 |
$ |
689,539 |
$ |
399,806 |
|||||||
% of total revenues |
57.1% |
34.0% |
50.7% |
36.4% |
|||||||||||
Research and development |
$ |
132,696 |
$ |
78,922 |
$ |
209,269 |
$ |
165,029 |
|||||||
% of total revenues |
17.7% |
14.0% |
15.4% |
15.0% |
|||||||||||
Acquired in-process research and development |
$ |
— |
$ |
3,000 |
$ |
— |
$ |
205,250 |
|||||||
Impairment charge |
$ |
— |
$ |
— |
$ |
— |
$ |
136,139 |
|||||||
Income tax provision |
$ |
228,621 |
$ |
54,754 |
$ |
246,640 |
$ |
3,467 |
|||||||
Effective tax rate |
N/A(1) |
31.9% |
N/A(1) |
(9.2)% |
________________________
(1) |
Our effective tax rates for the three and six months ended |
Three Months Ended |
Six Months Ended |
||||||||||||||
(In thousands, except percentages) |
2021 |
2020 |
2021 |
2020 |
|||||||||||
Non-GAAP adjusted: |
|||||||||||||||
Cost of product sales |
$ |
50,226 |
$ |
26,087 |
$ |
88,419 |
$ |
53,071 |
|||||||
Gross margin |
93.3% |
95.3% |
93.5% |
95.1% |
|||||||||||
Selling, general and administrative |
$ |
269,440 |
$ |
170,386 |
$ |
497,840 |
$ |
358,190 |
|||||||
% of total revenues |
35.8% |
30.3% |
36.6% |
32.6% |
|||||||||||
Research and development |
$ |
118,525 |
$ |
71,259 |
$ |
186,455 |
$ |
150,981 |
|||||||
% of total revenues |
15.8% |
12.7% |
13.7% |
13.8% |
|||||||||||
Acquired in-process research and development |
$ |
— |
$ |
3,000 |
$ |
— |
$ |
205,250 |
|||||||
Income tax provision |
$ |
30,262 |
$ |
73,085 |
$ |
67,921 |
$ |
77,772 |
|||||||
Effective tax rate |
11.2% |
25.9% |
12.8% |
24.9% |
Operating expenses changed over the prior year periods primarily due to the following:
- Cost of product sales increased in the second quarter of 2021 compared to the same period in 2020, on a GAAP and non-GAAP adjusted basis, primarily due to increased net product sales as a result of the
GW Acquisition . In addition, an acquisition accounting inventory fair value step-up expense of$66.0 million impacted GAAP cost of product sales. - Selling, general and administrative (SG&A) expenses increased in the second quarter of 2021 compared to the same period in 2020, on a GAAP and on a non-GAAP adjusted basis, primarily due to an increase in compensation-related expenses driven by higher headcount as a result of the
GW Acquisition , increased investment in sales, marketing and launch activities primarily related to Sunosi, Xywav and Zepzelca in theU.S. and the addition of costs related to Epidiolex. SG&A expenses in the second quarter of 2021 on a GAAP basis also included transaction and integration related expenses of$129.5 million related to theGW Acquisition . - Research and development expenses increased in the second quarter of 2021 compared to the same period in 2020, on a GAAP and on a non-GAAP adjusted basis, primarily due to the addition of costs related to clinical programs for Epidiolex, nabiximols and cannabinoids, an increase in costs for JZP385 and an increase in compensation-related expenses due to higher headcount primarily driven by the
GW Acquisition . - On a GAAP basis, our income tax provision for the three months ended
June 30, 2021 , included an expense of$251.4 million arising on the remeasurement of ourU.K. net deferred tax liability, which arose primarily in relation to theGW Acquisition , due to a change in the statutory tax rate in theU.K. following enactment of theUK Finance Act 2021. Due to the impact of this expense, our effective tax rate for the three months endedJune 30, 2021 , on a GAAP basis is not a meaningful metric. - On a non-GAAP basis, the decrease in the effective tax rate in the second quarter of 2021 compared to the same period in 2020 was primarily due to the impact in 2020 of the disallowance of certain interest deductions, provision for the settlement reached with the French tax authorities, and the impact of the change in income mix.
Cash Flow and Balance Sheet
As of
For the six months ended
2021 Financial Guidance1
Guidance provided as of |
|||
(In millions) |
|
|
|
Revenues |
|
|
|
Total net product sales |
|
|
|
-Neuroscience |
|
|
|
-Oncology |
|
|
|
GAAP: |
|||
Guidance provided as of |
|||
(In millions, except per share amounts and percentages) |
|
|
|
Gross margin % |
86% |
85% |
|
SG&A expenses |
|
|
|
SG&A expenses as % of total revenues |
46% - 52% |
46% - 52% |
|
R&D Expenses |
|
|
|
R&D expenses as % of total revenues |
17% - 20% |
17% - 20% |
|
Effective tax rate |
18% - 21% |
(58%) - (102%) |
|
Net loss per diluted share |
( |
( |
|
Weighted-average ordinary shares used in per share calculations |
62 |
60 |
|
Non-GAAP: |
|||
Guidance provided as of |
|||
(In millions, except per share amounts and percentages) |
|
|
|
Gross margin % |
93% |
93%3,7 |
|
SG&A expenses |
|
|
|
SG&A expenses as % of total revenues |
35% - 39% |
35% - 39% |
|
R&D Expenses |
|
|
|
R&D expenses as % of total revenues |
16% - 18% |
16% - 18% |
|
Effective tax rate |
13% - 15% |
13% - 15%6,7 |
|
Net income per diluted share |
|
|
|
Weighted-average ordinary shares used in per share calculations |
62 |
62 |
____________________________
1. |
The Company's 2021 financial guidance includes the anticipated results of the acquired GW business from the date of acquisition ( |
2. |
The Company expects the transaction to be dilutive to both GAAP and non-GAAP adjusted net income per diluted share in 2021. On a GAAP basis, this is expected to be primarily due to an increase in the amortization of acquisition-related intangible assets and transaction and integration related expenses, the amortization of inventory fair value step-up, increased interest expense and an increase in number of outstanding shares relating to the GW Acquisition. On a non-GAAP adjusted basis, this is expected to be due to increased cash interest expense and an increase in the number of outstanding shares. |
3. |
Excludes |
4. |
Excludes |
5. |
Excludes |
6. |
Excludes the income tax effect of adjustments between GAAP net income and non-GAAP adjusted net income and an expense of $251 million arising on the remeasurement of our |
7. |
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 2021 Net Income Guidance" at the end of this press release. |
Conference Call Details
A replay of the conference call will be available through
About Jazz Pharmaceuticals
Non-GAAP Financial Measures
To supplement
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.
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 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. For example, 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 net income per diluted share. 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
Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the Company's growth prospects and future financial and operating results, including the Company's 2021 financial guidance and the Company's expectations related thereto; the potential launch of Xywav in IH and the timing thereof; the completion of integration in connection with the acquisition of GW Pharmaceuticals and the anticipated benefits of the addition of the GW Pharmaceuticals pipeline and cannabinoid platform to the Company's own pipeline; the anticipated supply and other benefits of Rylaze to patients and healthcare providers; the value of the Company's development platform; expected initiations of Epidiolex, nabiximols, JZP385, JZP150 and Zepzelca clinical trials and the timing thereof; the potential approval of nabiximols in MS Spasticity; the Company's plans to submit additional data for Rylaze; the therapeutic potential of the Company's product candidates; the value of the Company's diversified product portfolio; the Company's financing structure supporting its plans for rapid deleveraging to its stated targets; 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 the Company's oxybate products and other key marketed products; effectively launching and commercializing the Company's other products and product candidates; obtaining and maintaining adequate coverage and reimbursement for the Company's products; the time-consuming and uncertain regulatory approval process, including the risk that the Company's current and/or planned regulatory submissions may not be submitted, accepted or approved by applicable regulatory authorities in a timely manner or at all, including the risk that the Company's supplemental new drug application seeking approval for Xywav in IH may not be approved by FDA in a timely manner or at all; the costly and time-consuming pharmaceutical product development and the uncertainty of clinical success, including risks related to failure or delays in successfully initiating or completing clinical trials and assessing patients such as those being experienced, and expected to continue to be experienced, by the Company as a result of the effects of the COVID-19 pandemic; the Company's failure to realize the expected benefits of its acquisition of GW Pharmaceuticals, including the risk that the legacy GW Pharmaceuticals business will not be integrated successfully or that such integration may be more difficult, time-consuming or costly than expected; the ultimate duration and severity of the COVID-19 pandemic and resulting global economic, financial, and healthcare system disruptions and the current and potential future negative impacts to the Company's business operations and financial results; regulatory initiatives and changes in tax laws; market volatility; 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; complying with applicable
|
|||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF INCOME (LOSS) |
|||||||||||||||
(In thousands, except per share amounts) |
|||||||||||||||
(Unaudited) |
|||||||||||||||
Three Months Ended |
Six Months Ended |
||||||||||||||
2021 |
2020 |
2021 |
2020 |
||||||||||||
Revenues: |
|||||||||||||||
Product sales, net |
$ |
748,340 |
$ |
558,203 |
$ |
1,351,871 |
$ |
1,088,408 |
|||||||
Royalties and contract revenues |
3,471 |
4,233 |
7,521 |
8,754 |
|||||||||||
Total revenues |
751,811 |
562,436 |
1,359,392 |
1,097,162 |
|||||||||||
Operating expenses: |
|||||||||||||||
Cost of product sales (excluding amortization of acquired developed technologies) |
119,194 |
28,008 |
159,383 |
56,665 |
|||||||||||
Selling, general and administrative |
429,031 |
191,406 |
689,539 |
399,806 |
|||||||||||
Research and development |
132,696 |
78,922 |
209,269 |
165,029 |
|||||||||||
Intangible asset amortization |
140,480 |
62,974 |
208,672 |
125,821 |
|||||||||||
Acquired in-process research and development |
— |
3,000 |
— |
205,250 |
|||||||||||
Impairment charge |
— |
— |
— |
136,139 |
|||||||||||
Total operating expenses |
821,401 |
364,310 |
1,266,863 |
1,088,710 |
|||||||||||
Income (loss) from operations |
(69,590) |
198,126 |
92,529 |
8,452 |
|||||||||||
Interest expense, net |
(69,420) |
(26,210) |
(96,796) |
(44,706) |
|||||||||||
Foreign exchange gain (loss) |
2,950 |
(464) |
3,893 |
(1,596) |
|||||||||||
Income (loss) before income tax provision and equity in (gain) loss of investees |
(136,060) |
171,452 |
(374) |
(37,850) |
|||||||||||
Income tax provision |
228,621 |
54,754 |
246,640 |
3,467 |
|||||||||||
Equity in (gain) loss of investees |
(1,365) |
1,897 |
(5,530) |
1,715 |
|||||||||||
Net income (loss) |
$ |
(363,316) |
$ |
114,801 |
$ |
(241,484) |
$ |
(43,032) |
|||||||
Net income (loss) per ordinary share: |
|||||||||||||||
Basic |
$ |
(6.11) |
$ |
2.07 |
$ |
(4.17) |
$ |
(0.77) |
|||||||
Diluted |
$ |
(6.11) |
$ |
2.06 |
$ |
(4.17) |
$ |
(0.77) |
|||||||
Weighted-average ordinary shares used in per share calculations - basic |
59,448 |
55,413 |
57,966 |
55,684 |
|||||||||||
Weighted-average ordinary shares used in per share calculations - diluted |
59,448 |
55,864 |
57,966 |
55,684 |
|
|||||||||||||||
PRO FORMA NET PRODUCT SALES |
|||||||||||||||
(In thousands) |
|||||||||||||||
(Unaudited) |
|||||||||||||||
The following unaudited pro forma information represents the net product sales for the three and six months ended |
|||||||||||||||
Three Months Ended |
Six Months Ended |
||||||||||||||
2021 |
2020 |
2021 |
2020 |
||||||||||||
Xyrem |
$ |
334,182 |
$ |
446,808 |
$ |
669,732 |
$ |
854,683 |
|||||||
Xywav |
124,164 |
— |
199,580 |
— |
|||||||||||
Total Oxybate |
458,346 |
446,808 |
869,312 |
854,683 |
|||||||||||
Epidiolex/Epidyolex |
155,868 |
117,741 |
304,130 |
233,883 |
|||||||||||
Sunosi |
12,124 |
8,578 |
23,730 |
10,502 |
|||||||||||
Sativex® (delta-9-tetrahydrocannabiol and cannabidiol) |
3,548 |
3,488 |
7,728 |
7,873 |
|||||||||||
Total Neuroscience |
629,886 |
576,615 |
1,204,900 |
1,106,941 |
|||||||||||
Zepzelca |
55,924 |
— |
110,258 |
— |
|||||||||||
Defitelio |
48,096 |
42,714 |
97,715 |
90,146 |
|||||||||||
Vyxeos |
31,453 |
26,568 |
64,608 |
59,288 |
|||||||||||
Erwinaze/Erwinase |
28,314 |
32,683 |
69,382 |
70,415 |
|||||||||||
Total Oncology |
163,787 |
101,965 |
341,963 |
219,849 |
|||||||||||
Other |
2,641 |
852 |
5,424 |
3,374 |
|||||||||||
Product sales, net |
$ |
796,314 |
$ |
679,432 |
$ |
1,552,287 |
$ |
1,330,164 |
|
|||||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||||
(In thousands) |
|||||||
(Unaudited) |
|||||||
2021 |
2020 |
||||||
ASSETS |
|||||||
Current assets: |
|||||||
Cash and cash equivalents |
$ |
891,400 |
$ |
1,057,769 |
|||
Investments |
— |
1,075,000 |
|||||
Accounts receivable, net of allowances |
506,660 |
396,490 |
|||||
Inventories |
1,251,259 |
95,396 |
|||||
Prepaid expenses |
104,455 |
62,422 |
|||||
Other current assets |
200,190 |
152,491 |
|||||
Total current assets |
2,953,964 |
2,839,568 |
|||||
Property, plant and equipment, net |
277,066 |
127,935 |
|||||
Operating lease assets |
149,254 |
129,169 |
|||||
Intangible assets, net |
7,588,029 |
2,195,051 |
|||||
|
1,887,699 |
958,303 |
|||||
Deferred tax assets, net |
296,493 |
254,916 |
|||||
Deferred financing costs |
13,406 |
5,238 |
|||||
Other non-current assets |
47,082 |
25,721 |
|||||
Total assets |
$ |
13,212,993 |
$ |
6,535,901 |
|||
LIABILITIES AND SHAREHOLDERS' EQUITY |
|||||||
Current liabilities: |
|||||||
Accounts payable |
$ |
64,826 |
$ |
26,945 |
|||
Accrued liabilities |
561,091 |
352,732 |
|||||
Current portion of long-term debt |
248,585 |
246,322 |
|||||
Income taxes payable |
3,645 |
25,200 |
|||||
Deferred revenue |
2,441 |
2,546 |
|||||
Total current liabilities |
880,588 |
653,745 |
|||||
Deferred revenue, non-current |
1,510 |
2,315 |
|||||
Long-term debt, less current portion |
6,489,315 |
1,848,516 |
|||||
Operating lease liabilities, less current portion |
156,556 |
140,035 |
|||||
Deferred tax liabilities, net |
1,421,027 |
130,397 |
|||||
Other non-current liabilities |
132,507 |
101,148 |
|||||
Total shareholders' equity |
4,131,490 |
3,659,745 |
|||||
Total liabilities and shareholders' equity |
$ |
13,212,993 |
$ |
6,535,901 |
|
|||||||
SUMMARY OF CASH FLOWS |
|||||||
(In thousands) |
|||||||
(Unaudited) |
|||||||
Six Months Ended |
|||||||
2021 |
2020 |
||||||
Net cash provided by operating activities |
$ |
326,692 |
$ |
455,488 |
|||
Net cash used in investing activities |
(5,175,238) |
(801,245) |
|||||
Net cash provided by financing activities |
4,682,312 |
494,851 |
|||||
Effect of exchange rates on cash and cash equivalents |
(135) |
(356) |
|||||
Net increase (decrease) in cash and cash equivalents |
$ |
(166,369) |
$ |
148,738 |
|
|||||||||||||||
RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION |
|||||||||||||||
(In thousands, except per share amounts) |
|||||||||||||||
(Unaudited) |
|||||||||||||||
Three Months Ended |
Six Months Ended |
||||||||||||||
2021 |
2020 |
2021 |
2020 |
||||||||||||
GAAP reported net income (loss) |
$ |
(363,316) |
$ |
114,801 |
$ |
(241,484) |
$ |
(43,032) |
|||||||
Intangible asset amortization |
140,480 |
62,974 |
208,672 |
125,821 |
|||||||||||
Share-based compensation expense |
43,411 |
30,604 |
77,896 |
59,258 |
|||||||||||
Transaction and integration related expenses1 |
133,328 |
— |
141,590 |
— |
|||||||||||
Non-cash interest expense2 |
22,322 |
17,268 |
38,010 |
29,268 |
|||||||||||
Acquisition accounting inventory fair value step-up |
65,991 |
— |
65,991 |
— |
|||||||||||
Impairment charge3 |
— |
— |
— |
136,139 |
|||||||||||
Income tax effect of above adjustments |
(53,021) |
(18,331) |
(72,661) |
(74,305) |
|||||||||||
Impact of |
251,380 |
— |
251,380 |
— |
|||||||||||
Non-GAAP adjusted net income |
$ |
240,575 |
$ |
207,316 |
$ |
469,394 |
$ |
233,149 |
|||||||
GAAP reported net income (loss) per diluted share |
$ |
(6.11) |
$ |
2.06 |
$ |
(4.17) |
$ |
(0.77) |
|||||||
Non-GAAP adjusted net income per diluted share |
$ |
3.90 |
$ |
3.71 |
$ |
7.82 |
$ |
4.14 |
|||||||
Weighted-average ordinary shares used in diluted per share calculations - GAAP |
59,448 |
55,864 |
57,966 |
55,684 |
|||||||||||
Weighted-average ordinary shares used in diluted per share calculations - non-GAAP |
61,686 |
55,864 |
60,047 |
56,328 |
________________________________________________
Explanation of Adjustments and Certain Line Items:
1. |
Transaction and integration related expenses related to the |
2. |
Non-cash interest expense associated with debt discount and debt issuance costs. |
3. |
Impairment charge related to the Company's decision to stop enrollment in its Phase 3 clinical trial of defibrotide for the prevention of veno-occlusive disease. |
4. |
Expense arising on the remeasurement of our |
|
|||||||||||||||||||||||||||||
RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION |
|||||||||||||||||||||||||||||
CERTAIN LINE ITEMS - FOR THE THREE MONTHS ENDED |
|||||||||||||||||||||||||||||
(In thousands, except percentages) |
|||||||||||||||||||||||||||||
(Unaudited) |
|||||||||||||||||||||||||||||
Three months ended |
|||||||||||||||||||||||||||||
Cost of sales |
Gross |
Selling, general |
Research and |
Intangible |
Interest |
Income tax |
Effective tax |
||||||||||||||||||||||
GAAP Reported |
$ |
119,194 |
84.1% |
$ |
429,031 |
$ |
132,696 |
$ |
140,480 |
$ |
69,420 |
$ |
228,621 |
N/A(1) |
|||||||||||||||
Non-GAAP Adjustments: |
|||||||||||||||||||||||||||||
Intangible asset amortization |
— |
— |
— |
— |
(140,480) |
— |
— |
— |
|||||||||||||||||||||
Share-based compensation expense |
(2,572) |
0.4 |
(30,046) |
(10,793) |
— |
— |
— |
— |
|||||||||||||||||||||
Transaction and integration related expenses |
(405) |
— |
(129,545) |
(3,378) |
— |
— |
— |
— |
|||||||||||||||||||||
Non-cash interest expense |
— |
— |
— |
— |
— |
(22,322) |
— |
— |
|||||||||||||||||||||
Acquisition accounting inventory fair value step-up |
(65,991) |
8.8 |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||
Income tax effect of above adjustments |
— |
— |
— |
— |
— |
— |
53,021 |
N/A(1) |
|||||||||||||||||||||
Impact of |
— |
— |
— |
— |
— |
— |
(251,380) |
N/A(1) |
|||||||||||||||||||||
Total of Non-GAAP adjustments |
(68,968) |
9.2 |
(159,591) |
(14,171) |
(140,480) |
(22,322) |
(198,359) |
N/A(1) |
|||||||||||||||||||||
Non-GAAP Adjusted |
$ |
50,226 |
93.3% |
$ |
269,440 |
$ |
118,525 |
$ |
— |
$ |
47,098 |
$ |
30,262 |
11.2% |
__________________________
(1) |
Due to the impact of the |
Three months ended |
|||||||||||||||||||||||||||||
Cost of |
Gross |
Selling, general |
Research and |
Intangible |
Interest |
Income tax |
Effective tax |
||||||||||||||||||||||
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 |
— |
— |
— |
— |
— |
(17,268) |
— |
— |
|||||||||||||||||||||
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% |
|
|||||||||||||||||||||||||||||
RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION |
|||||||||||||||||||||||||||||
CERTAIN LINE ITEMS - FOR THE SIX MONTHS ENDED |
|||||||||||||||||||||||||||||
(In thousands, except percentages) |
|||||||||||||||||||||||||||||
(Unaudited) |
|||||||||||||||||||||||||||||
Six months ended |
|||||||||||||||||||||||||||||
Cost of |
Gross |
Selling, general |
Research and |
Intangible |
Interest |
Income tax |
Effective tax |
||||||||||||||||||||||
GAAP Reported |
$ |
159,383 |
88.2% |
$ |
689,539 |
$ |
209,269 |
$ |
208,672 |
$ |
96,796 |
$ |
246,640 |
N/A(1) |
|||||||||||||||
Non-GAAP Adjustments: |
|||||||||||||||||||||||||||||
Intangible asset amortization |
— |
— |
— |
— |
(208,672) |
— |
— |
— |
|||||||||||||||||||||
Share-based compensation expense |
(4,568) |
0.4 |
(53,892) |
(19,436) |
— |
— |
— |
— |
|||||||||||||||||||||
Transaction and integration related expenses |
(405) |
— |
(137,807) |
(3,378) |
— |
— |
— |
— |
|||||||||||||||||||||
Non-cash interest expense |
— |
— |
— |
— |
— |
(38,010) |
— |
— |
|||||||||||||||||||||
Acquisition accounting inventory fair value step-up |
(65,991) |
4.9 |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||
Income tax effect of above adjustments |
— |
— |
— |
— |
— |
— |
72,661 |
N/A(1) |
|||||||||||||||||||||
Impact of |
— |
— |
— |
— |
— |
— |
(251,380) |
N/A(1) |
|||||||||||||||||||||
Total of Non-GAAP adjustments |
(70,964) |
5.3 |
(191,699) |
(22,814) |
(208,672) |
(38,010) |
(178,719) |
N/A(1) |
|||||||||||||||||||||
Non-GAAP Adjusted |
$ |
88,419 |
93.5% |
$ |
497,840 |
$ |
186,455 |
$ |
— |
$ |
58,786 |
$ |
67,921 |
12.8% |
__________________________
(1) |
Due to the impact of the |
Six months ended |
|||||||||||||||||||||||||||||||||
Cost of |
Gross |
Selling, general |
Research |
Intangible |
Impairment |
Interest |
Income tax |
Effective |
|||||||||||||||||||||||||
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 charge |
— |
— |
— |
— |
— |
(136,139) |
— |
— |
— |
||||||||||||||||||||||||
Non-cash interest expense |
— |
— |
— |
— |
— |
— |
(29,268) |
— |
— |
||||||||||||||||||||||||
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% |
|
|
RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED 2021 NET INCOME GUIDANCE |
|
(In millions, except per share amounts) |
|
(Unaudited) |
|
GAAP net loss |
( |
Intangible asset amortization |
525 – 545 |
Acquisition accounting inventory fair value step-up |
220 – 260 |
Share-based compensation expense |
170 – 190 |
Transaction and integration related expenses |
230 – 260 |
Non-cash interest expense |
90 – 110 |
Income tax effect of above adjustments |
(195) - (205) |
Impact of |
251 |
Non-GAAP adjusted net income |
$830 – |
GAAP net loss per diluted share |
( |
Non-GAAP adjusted net income per diluted share |
|
Weighted-average ordinary shares used in per share calculations - GAAP |
60 |
Weighted-average ordinary shares used in per share calculations - Non-GAAP |
62 |
Contacts:
Investors:
Vice President, Head, Investor Relations
investorinfo@jazzpharma.com
Media:
Vice President, Corporate Affairs & Government Relations
CorporateAffairsMediaInfo@jazzpharma.com
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