JAZZ PHARMACEUTICALS ANNOUNCES FULL YEAR AND FOURTH QUARTER 2021 FINANCIAL RESULTS
"2021 was a transformative year for Jazz, delivering over $3 billion in revenue for the first time. Our talented team achieved our goal of five key launches through 2020 and 2021, delivering innovative medicines to patients in critical need. We also acquired and integrated
"In 2021, our R&D organization advanced key programs across our portfolio, further broadening our pipeline into disease areas with significant unmet patient need and market potential. In the fourth quarter, we made important progress with key programs, including Phase 2 trial initiations in essential tremor and PTSD. Jazz and its partners also initiated multiple clinical trials to evaluate Zepzelca® together with Tecentriq® in first-line extensive stage small cell lung cancer (SCLC), and in its current indication in second-line SCLC. We were also pleased to have submitted a Supplemental Biologics License Application (sBLA) for Rylaze™ for Monday/Wednesday/Friday intramuscular dosing at the end of January, which will be reviewed under the Real-Time Oncology Review (RTOR) program," said
Key Highlights
Commercial and R&D Excellence
- Positive early feedback underpins
November 2021 launch of Xywav® for idiopathic hypersomnia - Drove exceptional Xywav adoption in narcolepsy in 2021
- Epidiolex/Epidyolex® year-over-year revenue growth1 of 29% underscores blockbuster potential
- Rapidly established Zepzelca as the treatment of choice in second-line SCLC
- Rylaze launch progressing well with strong early demand
- Significant revenue diversification with 59% of net product sales in 4Q21 from products launched or acquired since 2019
- Advanced value-driving pipeline programs with 5 key trials initiated in 2H21
- Entering 2022 well-positioned to deliver on Vision 2025
Financial
- Growing and durable commercial franchises drove 2021 total revenues of
$3.1 billion ; 31% increase compared to 2020 - Significant deleveraging accomplished following GW acquisition:
- Net leverage ratio at 4.1x as of
December 31, 2021 2 - 0.8x improvement in 8 months following close of GW transaction
- On-track for target of less than 3.5x by the end of 2022
- Meaningful top- and bottom-line growth expected with 2022 total revenue guidance of
$3.46 to$3 .66 billion
________________________ |
|
1. |
On a proforma basis |
2. |
On a non-GAAP adjusted basis. Non-GAAP net leverage ratio is a non-GAAP financial measure. For further information, see " Non-GAAP Financial Measures." |
Business Updates
Key Commercial Products
Oxybate (Xywav and Xyrem®):
- Net product sales for the combined oxybate business increased 3% to
$1,801 .1 million in 2021 and increased 4% to$471 .4 million in 4Q21 compared to the same periods in 2020. - Average active oxybate patients on therapy was approximately 16,200 in 4Q21, an increase of approximately 6% compared to the same period in 2020.
Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
- Xywav net product sales were
$535.3 million in 2021 and$182.7 million in 4Q21. - There were approximately 6,900 active Xywav patients exiting 4Q21.
- Xywav has broad patent protection to 2033.
Xywav for Narcolepsy:
- In 2021, the Company drove market-leading adoption of Xywav in narcolepsy.
- There were approximately 6,650 active Xywav patients with narcolepsy exiting 4Q21.
- In
June 2021 , FDA recognized seven years of Orphan Drug Exclusivity (ODE), throughJuly 2027 , for Xywav and published its summary of clinical superiority findings 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." Further, FDA stated 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."
Xywav for Idiopathic Hypersomnia (IH):
- The Company launched Xywav for IH on
November 1, 2021 , with initial launch efforts focused on the approximately 37,000 currently diagnosed patients in theU.S. who are actively seeking healthcare. - Positive early launch momentum with approximately 250 active Xywav patients with IH exiting 4Q21. Healthcare providers are excited to have a treatment option with positive and compelling clinical trial results that address IH and not just its symptoms.
- FDA recognized ODE for IH in
January 2022 extending toAugust 2028 .
Xyrem (sodium oxybate) oral solution:
- Xyrem net product sales decreased 27% to
$1,265.8 million in 2021 and decreased 34% to$288 .8 million in 4Q21 compared to the same periods in 2020, reflecting the continued strong adoption of Xywav.
Epidiolex/Epidyolex (cannabidiol):
- Epidiolex/Epidyolex net product sales were
$463.6 million in 2021, or$658.3 million on a proforma basis, and$193.8 million in 4Q21. On a proforma basis, these net product sales represent growth of 29% and 35% compared to 2020 and 4Q20 respectively. - Net product sales in 4Q21 were favorably impacted by approximately
$18 million , compared to 3Q21, relating to a temporary increase in specialty pharmacy inventory levels. - Epidyolex is now commercially available and fully reimbursed in four of the five key European markets:
United Kingdom ,Germany ,Italy andSpain , with an anticipated launch inFrance in 2022. The Company has made significant progress on its European rollout with launches inSpain ,Italy andSwitzerland in 3Q21 andIreland in 1Q22. - The Company expects to initiate a Phase 3 pivotal trial of Epidiolex for Epilepsy with Myoclonic-Atonic Seizures (EMAS), the fourth target indication for Epidiolex, in 1H22.
- The Company continues to strengthen the IP durability of Epidiolex. The
U.S. FDA Orange Book Listed patent (US 11,207,292) was granted inDecember 2021 , and extends through 2039. This patent covers the composition of the botanically derived cannabidiol (CBD) preparation used in Epidiolex and the treatment of indicated disorders using that CBD preparation.
Zepzelca (lurbinectedin):
- Zepzelca net product sales were
$246.8 million in 2021, the first full calendar year on the market following launch inJuly 2020 , and increased 21% to$64.8 million in 4Q21 compared to 4Q20. - The Company is pleased to have established Zepzelca as the treatment of choice in the second-line SCLC setting after only eighteen months on the market.
- Zepzelca development program updates:
- The Company has initiated the Phase 2 basket trial evaluating Zepzelca as monotherapy in select relapsed/refractory solid tumors.
- Jazz and collaborator
F. Hoffmann-La Roche Ltd (Roche) have initiated a Phase 3 trial to evaluate first-line use of Zepzelca in combination with Tecentriq® (atezolizumab), compared to Tecentriq alone, as maintenance therapy, in patients with extensive-stage SCLC after induction chemotherapy. The first patient was enrolled inNovember 2021 . - The Company's partner, PharmaMar, initiated a confirmatory trial, LAGOON, in second-line SCLC in
December 2021 . 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.
Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn):
- Rylaze net product sales were
$85.6 million in 2021 and$65.0 million in 4Q21, following commercial launch onJuly 15, 2021 . 2021 revenues reflect the strong demand for Rylaze and include initial inventory build. - In
January 2022 , the Company completed the submission of an sBLA to FDA seeking approval for a Monday/Wednesday/Friday (M/W/F) intramuscular dosing schedule for Rylaze. The submission will be reviewed under the RTOR program. - The Company presented initial data, for the first time, from the Phase 2/3 study of Rylaze in patients with acute lymphoblastic leukemia and lymphoblastic lymphoma who developed hypersensitivity or silent inactivation to a long-acting E. coli–derived asparaginase, at the 63rd
American Society of Hematology Annual Meeting inDecember 2021 . This data showed that with the proposed M/W/F dosing schedule, patients maintain a clinically meaningful level of nadir serum asparaginase activity through the entire duration of treatment. - The Company anticipates that data from the current development program will support regulatory filings in
Europe in mid-2022, including intravenous (IV) administration, with potential for approval in 2023, as well as a further submission to FDA to support IV administration later this year. The Company is also working with a partner to advance the program for potential submission, approval and launch inJapan .
Key Pipeline Highlights
Nabiximols:
- The Company initiated the third Phase 3 nabiximols clinical trial, NCT04984278, in multiple sclerosis (MS)-related spasticity in 3Q21. This is a randomized, double-blind, placebo-controlled trial with a primary endpoint of muscle tone, expected to enroll approximately 190 patients.
- The Company anticipates data from its first Phase 3 trial, NCT04657666, in 1H22; positive findings may enable a New Drug Application submission to FDA in 2022. Data from the two additional Phase 3 trials will follow in late 2022 and early 2023.
Suvecaltamide (JZP385):
- Suvecaltamide, a highly selective modulator of T-type calcium channels, is in clinical development for the treatment of essential tremor.
- The Company initiated a Phase 2b trial in 4Q21 and announced that the first patient was enrolled in
December 2021 . Top-line data read-out is anticipated in 1H24.
JZP150:
- JZP150, a selective fatty acid amide hydrolase, or FAAH, inhibitor, is in clinical development for the potential treatment of post-traumatic stress disorder (PTSD).
- The Company initiated a Phase 2 trial in 4Q21 and announced that the first patient was enrolled in
December 2021 . Top-line data read-out is anticipated in late 2023. - The Company received Fast Track Designation for JZP150 development in PTSD from FDA in 4Q21, underscoring the significant unmet medical needs of patients.
Other Products
Sunosi® (solriamfetol):
- Sunosi net product sales increased by 104% to
$57.9 million in 2021 and increased 71% to$14.9 million in 4Q21 compared to the same periods in 2020. - In 4Q21,
U.S. prescriptions increased by 4% compared to 3Q21.
Vyxeos® (daunorubicin and cytarabine) liposome for injection:
- Vyxeos net product sales increased 11% to
$134.1 million in 2021 and increased 12% to$34 .8 million in 4Q21 compared to the same periods in 2020.
Defitelio® (defibrotide sodium) / defibrotide:
- Defitelio/defibrotide net product sales increased 1% to
$197.9 million in 2021 and decreased 23% to$42 .5 million in 4Q21 compared to the same periods in 2020 due to the timing of distributor orders.
Financial Highlights
Three Months Ended |
Year Ended |
||||||
(In thousands, except per share amounts) |
2021 |
2020 |
2021 |
2020 |
|||
Total revenues |
$ 896,731 |
$ 665,517 |
$ 3,094,238 |
$ 2,363,567 |
|||
GAAP net income (loss) |
$ (35,351) |
$ 133,414 |
$ (329,668) |
$ 238,616 |
|||
Adjusted net income1 |
$ 262,012 |
$ 228,718 |
$ 992,824 |
$ 703,976 |
|||
GAAP EPS |
$ (0.57) |
$ 2.33 |
$ (5.52) |
$ 4.22 |
|||
Adjusted EPS1 |
$ 4.21 |
$ 4.00 |
$ 16.23 |
$ 12.46 |
_______________________ |
|
1. |
Commencing in 2020, following consultation with the staff of the |
GAAP net income (loss) for 2021 was (
Non-GAAP adjusted net income for 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 |
Year Ended |
||||||
(In thousands) |
2021 |
2020 |
2021 |
2020 |
|||
Xyrem |
$ 288,765 |
$ 439,266 |
$ 1,265,830 |
$ 1,741,758 |
|||
Xywav |
182,654 |
15,264 |
535,297 |
15,264 |
|||
Total Oxybate |
471,419 |
454,530 |
1,801,127 |
1,757,022 |
|||
Epidiolex/Epidyolex1 |
193,786 |
— |
463,645 |
— |
|||
Sunosi |
14,933 |
8,715 |
57,914 |
28,333 |
|||
Sativex® (nabiximols)1 |
4,649 |
— |
12,707 |
— |
|||
Total Neuroscience |
684,787 |
463,245 |
2,335,393 |
1,785,355 |
|||
Zepzelca |
64,836 |
53,439 |
246,808 |
90,380 |
|||
Rylaze |
64,955 |
— |
85,629 |
— |
|||
Vyxeos |
34,764 |
30,992 |
134,060 |
121,105 |
|||
Defitelio/defibrotide |
42,511 |
55,455 |
197,931 |
195,842 |
|||
Erwinaze/Erwinase |
— |
56,576 |
69,382 |
147,136 |
|||
Total Oncology |
207,066 |
196,462 |
733,810 |
554,463 |
|||
Other |
1,030 |
1,596 |
9,798 |
6,842 |
|||
Product sales, net |
892,883 |
661,303 |
3,079,001 |
2,346,660 |
|||
Royalties and contract revenues |
3,848 |
4,214 |
15,237 |
16,907 |
|||
Total revenues |
$ 896,731 |
$ 665,517 |
$ 3,094,238 |
$ 2,363,567 |
__________________________ |
|
1. |
Net product sales for Epidiolex/Epidyolex and Sativex are included from the acquisition of |
Total revenues increased 31% in 2021 and 35% in 4Q21 compared to the same periods in 2020.
- Products launched or acquired since 2019 comprised 59% of total net product sales in 4Q21.
- Neuroscience net product sales in 2021 increased 31% to
$2,335.4 million compared to 2020 primarily driven by Epidiolex/Epidyolex net product sales in 2021 of$463 .6 million, following theGW Acquisition . In 2021, oxybate net product sales increased 3% to$1,801 .1 million led by strong Xywav net product sales of$535 .3 million partially offset by a decrease in Xyrem net product sales as a result of the strong adoption of Xywav by existing Xyrem patients. Neuroscience net product sales in 4Q21 increased 48% to$684 .8 million compared to the same period in 2020 primarily driven by Epidiolex/Epidyolex net product sales in 4Q21 of$193 .8 million. In 4Q21, oxybate net product sales increased 4% to$471 .4 million. - Oncology net product sales in 2021 increased 32% to
$733.8 million compared to 2020 primarily driven by an increase in Zepzelca net product sales of$156.4 million , following launch in theU.S. inJuly 2020 . Oncology net product sales in 4Q21 increased 5% to$207 .1 million compared to the same period in 2020 primarily driven by an increase in Zepzelca net product sales of$11 .4 million.
Operating Expenses and Effective Tax Rate
Three Months Ended |
Year Ended |
||||||
(In thousands, except percentages) |
2021 |
2020 |
2021 |
2020 |
|||
GAAP: |
|||||||
Cost of product sales |
$ 136,153 |
$ 50,157 |
$ 440,760 |
$ 148,917 |
|||
Gross margin |
84.8% |
92.4% |
85.7% |
93.7% |
|||
Selling, general and administrative |
$ 398,462 |
$ 247,172 |
$ 1,451,683 |
$ 854,233 |
|||
% of total revenues |
44.4% |
37.1% |
46.9% |
36.1% |
|||
Research and development |
$ 155,443 |
$ 91,699 |
$ 505,748 |
$ 335,375 |
|||
% of total revenues |
17.3% |
13.8% |
16.3% |
14.2% |
|||
Acquired in-process research and development |
$ — |
$ 36,000 |
$ — |
$ 251,250 |
|||
Impairment charge |
$ — |
$ — |
$ — |
$ 136,139 |
|||
Income tax expense (benefit) |
$ (12,467) |
$ 10,767 |
$ 216,116 |
$ 33,517 |
|||
Effective tax rate |
27.8% |
7.4% |
N/A (1) |
12.2% |
____________________ |
|
(1) |
Our effective tax rate for the year ended |
Three Months Ended |
Year Ended |
||||||
(In thousands, except percentages) |
2021 |
2020 |
2021 |
2020 |
|||
Non-GAAP adjusted: |
|||||||
Cost of product sales |
$ 58,110 |
$ 48,298 |
$ 205,401 |
$ 141,545 |
|||
Gross margin |
93.5% |
92.7% |
93.3% |
94.0% |
|||
Selling, general and administrative |
$ 328,656 |
$ 225,378 |
$ 1,105,048 |
$ 769,849 |
|||
% of total revenues |
36.7% |
33.9% |
35.7% |
32.6% |
|||
Research and development |
$ 140,101 |
$ 83,968 |
$ 451,026 |
$ 306,133 |
|||
% of total revenues |
15.6% |
12.6% |
14.6% |
13.0% |
|||
Acquired in-process research and development |
$ — |
$ 36,000 |
$ — |
$ 251,250 |
|||
Income tax expense |
$ 37,254 |
$ 29,968 |
$ 148,764 |
$ 146,008 |
|||
Effective tax rate |
12.3% |
11.6% |
13.0% |
17.1% |
Operating expenses changed over the prior year periods primarily due to the following:
- Cost of product sales increased in 2021 and in 4Q21 compared to the same periods in 2020, on a GAAP and on a non-GAAP adjusted basis, due to increased net product sales as a result of the
GW Acquisition . In addition, acquisition accounting inventory fair value step-up expense of$223.1 million in 2021 and$74.4 million in 4Q21 impacted GAAP cost of product sales. - Selling, general and administrative (SG&A) expenses increased in 2021 and in 4Q21 compared to the same periods 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 and increased investment to support the Company's recent product launches. SG&A expenses in 2021 and in 4Q21 on a GAAP basis also included transaction and integration related expenses of$229.0 million and$37.8 million related to theGW Acquisition . - Research and development (R&D) expenses increased in 2021 and in 4Q21 compared to the same periods in 2020, on a GAAP and on a non-GAAP adjusted basis, primarily due to the addition of costs related to clinical programs for nabiximols, Epidiolex and cannabinoids, an increase in costs related to suvecaltamide (JZP385) and JZP150, an increase in compensation-related expenses due to higher headcount primarily driven by the
GW Acquisition and milestone expense of$10.0 million in 4Q21 relating to our asset purchase and collaboration agreements with Redx Pharma. - Acquired in-process research and development (IPR&D) expense in 2020 on a GAAP and on a non-GAAP adjusted basis primarily related to a
$200.0 million upfront payment to PharmaMar for the exclusiveU.S. commercialization and development rights to Zepzelca and a$35.0 million upfront payment to SpringWorks Therapeutics, Inc., in the fourth quarter, for a FAAH inhibitor program. - In 2020, the Company recorded an impairment charge of
$136.1 million on a GAAP basis following the Company's decision to stop enrollment in its Phase 3 clinical study of defibrotide for the prevention of veno-occlusive disease due to an Independent Data Monitoring Committee determination that it was highly unlikely that the study would reach its primary endpoint.
Cash Flow and Balance Sheet
As of
2022 Financial Guidance
(In millions) |
Guidance |
|
Revenues |
|
|
–Neuroscience (includes potential Xyrem authorized generic royalties) |
|
|
–Oncology |
|
(In millions, except per share amounts and percentages) |
GAAP |
Non-GAAP |
|
Gross margin % |
83% |
92%1,6 |
|
SG&A expenses |
|
|
|
SG&A expenses as % of total revenues |
35% - 40% |
31% - 34% |
|
R&D expenses |
|
|
|
R&D expenses as % of total revenues |
17% - 19% |
15% - 17% |
|
Effective tax rate |
(116)% - (32)% |
10% - 12%4,6 |
|
Net income |
|
|
|
Net income per diluted share5 |
|
|
|
Weighted-average ordinary shares used in per share calculations5 |
72 |
72 |
____________________________ |
|
1. |
Excludes |
2. |
Excludes |
3. |
Excludes |
4. |
Excludes the income tax effect of adjustments between GAAP net income and non-GAAP adjusted net income. |
5. |
We adopted ASU No. 2020-06, "Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging— Contracts in Entity's Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity's Own Equity", or ASU 2020-06, on |
Following the adoption of ASU 2020-06, diluted EPS must be calculated using the if-converted method which assumes full conversion of our Exchangeable Senior Notes. Diluted EPS calculations for 2022 include 9 million shares related to the assumed conversion of the Exchangeable Senior Notes and the associated interest expense add-back to net income of
Non-GAAP adjusted EPS guidance for 2022 reflects dilution of approximately
As illustrated below, had ASU 2020-06 been adopted in 2021, the impact on adjusted EPS for the year ended
Year Ended |
|||||
(In thousands, except per share amounts) |
Current |
Impact of ASU |
Post ASU 2020-06 |
||
GAAP reported net loss per diluted share |
$ (5.52) |
$ — |
$ (5.52) |
||
Non-GAAP adjusted net income per diluted share |
$ 16.23 |
$ (1.73) |
$ 14.50 |
||
Weighted-average ordinary shares used in diluted per share calculations - GAAP |
59,694 |
— |
59,694 |
||
Weighted-average ordinary shares used in diluted per share calculations - non-GAAP |
61,164 |
9,044 |
70,208 |
*For illustrative purposes only to enable year over year comparison as ASU 2020-06 was adopted on |
|
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 2022 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 and 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, to identify operating trends in the Company's business and to understand the Company's ability to delever. In addition, these non-GAAP financial measures are regularly used by investors and analysts to model and track the Company's financial performance.
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 2022 financial guidance and the Company's expectations related thereto; the Company's expectation of sustainable growth and enhanced value as part of its Vision 2025; growing and diversifying the Company's revenue, investing in its pipeline of novel therapies, and delivering innovative therapies for patients; the Company's expectation of delivering at least five additional novel product approvals by the end of the decade; the Company's ability to realize the commercial potential of its products, including the blockbuster potential of Epidiolex; the Company's views and expectations relating to its patent portfolio, including with respect to expected patent protection; planned or anticipated clinical trial events, including with respect to initiations, enrollment and data read-outs, and the anticipated timing thereof; the Company's clinical trials confirming clinical benefit or enabling regulatory submissions; planned or anticipated regulatory submissions and filings, including for nabiximols and Rylaze, and the anticipated timing thereof; potential regulatory approvals, including for Rylaze; the anticipated launch of Epidyolex in
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, Zepzelca 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 sBLA seeking approval for a revised dosing label for Rylaze 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
|
|||||||
CONDENSED CONSOLIDATED STATEMENTS OF INCOME (LOSS) |
|||||||
(In thousands, except per share amounts) |
|||||||
(Unaudited) |
|||||||
Three Months Ended |
Year Ended |
||||||
2021 |
2020 |
2021 |
2020 |
||||
Revenues: |
|||||||
Product sales, net |
$ 892,883 |
$ 661,303 |
$ 3,079,001 |
$ 2,346,660 |
|||
Royalties and contract revenues |
3,848 |
4,214 |
15,237 |
16,907 |
|||
Total revenues |
896,731 |
665,517 |
3,094,238 |
2,363,567 |
|||
Operating expenses: |
|||||||
Cost of product sales (excluding amortization of |
136,153 |
50,157 |
440,760 |
148,917 |
|||
Selling, general and administrative |
398,462 |
247,172 |
1,451,683 |
854,233 |
|||
Research and development |
155,443 |
91,699 |
505,748 |
335,375 |
|||
Intangible asset amortization |
157,293 |
67,075 |
525,769 |
259,580 |
|||
Acquired in-process research and development |
— |
36,000 |
— |
251,250 |
|||
Impairment charge |
— |
— |
— |
136,139 |
|||
Total operating expenses |
847,351 |
492,103 |
2,923,960 |
1,985,494 |
|||
Income from operations |
49,380 |
173,414 |
170,278 |
378,073 |
|||
Interest expense, net |
(88,598) |
(27,573) |
(278,766) |
(99,707) |
|||
Foreign exchange loss |
(5,612) |
(1,036) |
(4,350) |
(3,271) |
|||
Income (loss) before income tax expense (benefit) and |
(44,830) |
144,805 |
(112,838) |
275,095 |
|||
Income tax expense (benefit) |
(12,467) |
10,767 |
216,116 |
33,517 |
|||
Equity in loss of investees |
2,988 |
624 |
714 |
2,962 |
|||
Net income (loss) |
$ (35,351) |
$ 133,414 |
$ (329,668) |
$ 238,616 |
|||
Net income (loss) per ordinary share: |
|||||||
Basic |
$ (0.57) |
$ 2.39 |
$ (5.52) |
$ 4.28 |
|||
Diluted |
$ (0.57) |
$ 2.33 |
$ (5.52) |
$ 4.22 |
|||
Weighted-average ordinary shares used in per share |
61,503 |
55,935 |
59,694 |
55,712 |
|||
Weighted-average ordinary shares used in per share |
61,503 |
57,174 |
59,694 |
56,517 |
|
|||||||
PRO FORMA NET PRODUCT SALES |
|||||||
(In thousands) |
|||||||
(Unaudited) |
|||||||
The following unaudited pro forma information represents the net product sales for the three and twelve months ended |
|||||||
Three Months Ended |
Year Ended |
||||||
2021 |
2020 |
2021 |
2020 |
||||
Xyrem |
$ 288,765 |
$ 439,266 |
$ 1,265,830 |
$ 1,741,758 |
|||
Xywav |
182,654 |
15,264 |
535,297 |
15,264 |
|||
Total Oxybate |
471,419 |
454,530 |
1,801,127 |
1,757,022 |
|||
Epidiolex/Epidyolex |
193,786 |
144,075 |
658,294 |
510,503 |
|||
Sunosi |
14,933 |
8,715 |
57,914 |
28,333 |
|||
Sativex® (nabiximols) |
4,649 |
4,146 |
18,474 |
16,328 |
|||
Total Neuroscience |
684,787 |
611,466 |
2,535,809 |
2,312,186 |
|||
Zepzelca |
64,836 |
53,439 |
246,808 |
90,380 |
|||
Rylaze |
64,955 |
— |
85,629 |
— |
|||
Vyxeos |
34,764 |
30,992 |
134,060 |
121,105 |
|||
Defitelio/defibrotide |
42,511 |
55,455 |
197,931 |
195,842 |
|||
Erwinaze/Erwinase |
— |
56,576 |
69,382 |
147,136 |
|||
Total Oncology |
207,066 |
196,462 |
733,810 |
554,463 |
|||
Other |
1,030 |
1,595 |
9,798 |
6,841 |
|||
Product sales, net |
$ 892,883 |
$ 809,523 |
$ 3,279,417 |
$ 2,873,490 |
|
|||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||
(In thousands) |
|||
(Unaudited) |
|||
|
|||
2021 |
2020 |
||
ASSETS |
|||
Current assets: |
|||
Cash and cash equivalents |
$ 591,448 |
$ 1,057,769 |
|
Investments |
— |
1,075,000 |
|
Accounts receivable, net of allowances |
563,360 |
396,490 |
|
Inventories |
1,072,721 |
95,396 |
|
Prepaid expenses |
131,413 |
62,422 |
|
Other current assets |
252,392 |
152,491 |
|
Total current assets |
2,611,334 |
2,839,568 |
|
Property, plant and equipment, net |
256,837 |
127,935 |
|
Operating lease assets |
86,586 |
129,169 |
|
Intangible assets, net |
7,152,328 |
2,195,051 |
|
|
1,827,609 |
958,303 |
|
Deferred tax assets, net |
311,103 |
254,916 |
|
Deferred financing costs |
12,029 |
5,238 |
|
Other non-current assets |
40,813 |
25,721 |
|
Total assets |
$ 12,298,639 |
$ 6,535,901 |
|
LIABILITIES AND SHAREHOLDERS' EQUITY |
|||
Current liabilities: |
|||
Accounts payable |
$ 100,298 |
$ 26,945 |
|
Accrued liabilities |
666,304 |
352,732 |
|
Current portion of long-term debt |
31,000 |
246,322 |
|
Income taxes payable |
9,608 |
25,200 |
|
Deferred revenue |
2,093 |
2,546 |
|
Total current liabilities |
809,303 |
653,745 |
|
Deferred revenue, non-current |
463 |
2,315 |
|
Long-term debt, less current portion |
6,018,943 |
1,848,516 |
|
Operating lease liabilities, less current portion |
87,200 |
140,035 |
|
Deferred tax liabilities, net |
1,300,541 |
130,397 |
|
Other non-current liabilities |
116,998 |
101,148 |
|
Total shareholders' equity |
3,965,191 |
3,659,745 |
|
Total liabilities and shareholders' equity |
$ 12,298,639 |
$ 6,535,901 |
|
|||
SUMMARY OF CASH FLOWS |
|||
(In thousands) |
|||
(Unaudited) |
|||
Year Ended |
|||
2021 |
2020 |
||
Net cash provided by operating activities |
$ 778,507 |
$ 899,648 |
|
Net cash used in investing activities |
(5,212,143) |
(1,007,670) |
|
Net cash provided by financing activities |
3,970,522 |
528,073 |
|
Effect of exchange rates on cash and cash equivalents |
(3,207) |
374 |
|
Net increase (decrease) in cash and cash equivalents |
$ (466,321) |
$ 420,425 |
|
|||||||
RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION |
|||||||
(In thousands, except per share amounts) |
|||||||
(Unaudited) |
|||||||
Three Months Ended |
Year Ended |
||||||
2021 |
2020 |
2021 |
2020 |
||||
GAAP reported net income (loss) |
$ (35,351) |
$ 133,414 |
$ (329,668) |
$ 238,616 |
|||
Intangible asset amortization |
157,293 |
67,075 |
525,769 |
259,580 |
|||
Share-based compensation expense |
46,490 |
31,384 |
169,921 |
120,998 |
|||
Transaction and integration related expenses1 |
42,253 |
— |
243,710 |
— |
|||
Non-cash interest expense2 |
26,600 |
16,046 |
92,655 |
61,134 |
|||
Acquisition accounting inventory fair value step-up |
74,448 |
— |
223,085 |
— |
|||
Impairment charge3 |
— |
— |
— |
136,139 |
|||
Income tax effect of above adjustments |
(58,214) |
(19,201) |
(192,521) |
(112,491) |
|||
Impact of |
8,493 |
— |
259,873 |
— |
|||
Non-GAAP adjusted net income |
$ 262,012 |
$ 228,718 |
$ 992,824 |
$ 703,976 |
|||
GAAP reported net income (loss) per diluted share |
$ (0.57) |
$ 2.33 |
$ (5.52) |
$ 4.22 |
|||
Non-GAAP adjusted net income per diluted share |
$ 4.21 |
$ 4.00 |
$ 16.23 |
$ 12.46 |
|||
Weighted-average ordinary shares used in diluted per |
61,503 |
57,174 |
59,694 |
56,517 |
|||
Weighted-average ordinary shares used in diluted per |
62,218 |
57,174 |
61,164 |
56,517 |
________________________________________________ |
|
Explanation of Adjustments and Certain Line Items: |
|
1. |
Transaction and integration 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 the Company's |
|
|||||||||||||||
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 |
Gross |
Selling, general |
Research and |
Intangible |
Interest |
Income tax |
Effective |
||||||||
GAAP Reported |
$ 136,153 |
84.8% |
$ 398,462 |
$ 155,443 |
$ 157,293 |
$ 88,598 |
$ (12,467) |
27.8% |
|||||||
Non-GAAP Adjustments: |
|||||||||||||||
Intangible asset amortization |
— |
— |
— |
— |
(157,293) |
— |
— |
— |
|||||||
Share-based compensation |
(3,260) |
0.4 |
(32,029) |
(11,201) |
— |
— |
— |
— |
|||||||
Transaction and integration |
(335) |
— |
(37,777) |
(4,141) |
— |
— |
— |
— |
|||||||
Non-cash interest expense |
— |
— |
— |
— |
— |
(26,600) |
— |
— |
|||||||
Acquisition accounting |
(74,448) |
8.3 |
— |
— |
— |
— |
— |
— |
|||||||
Income tax effect of above |
— |
— |
— |
— |
— |
— |
58,214 |
(18.0) |
|||||||
Impact of |
— |
— |
— |
— |
— |
— |
(8,493) |
2.5 |
|||||||
Total of non-GAAP |
(78,043) |
8.7 |
(69,806) |
(15,342) |
(157,293) |
(26,600) |
49,721 |
(15.5) |
|||||||
Non-GAAP Adjusted |
$ 58,110 |
93.5% |
$ 328,656 |
$ 140,101 |
$ — |
$ 61,998 |
$ 37,254 |
12.3% |
Three months ended |
|||||||||||||||
Cost of |
Gross |
Selling, general |
Research and |
Intangible asset |
Interest |
Income tax |
Effective |
||||||||
GAAP Reported |
$ 50,157 |
92.4% |
$ 247,172 |
$ 91,699 |
$ 67,075 |
$ 27,573 |
$ 10,767 |
7.4% |
|||||||
Non-GAAP Adjustments: |
|||||||||||||||
Intangible asset amortization |
— |
— |
— |
— |
(67,075) |
— |
— |
— |
|||||||
Share-based compensation |
(1,859) |
0.3 |
(21,794) |
(7,731) |
— |
— |
— |
— |
|||||||
Non-cash interest expense |
— |
— |
— |
— |
— |
(16,046) |
— |
— |
|||||||
Income tax effect of above |
— |
— |
— |
— |
— |
— |
19,201 |
4.2 |
|||||||
Total of non-GAAP |
(1,859) |
0.3 |
(21,794) |
(7,731) |
(67,075) |
(16,046) |
19,201 |
4.2 |
|||||||
Non-GAAP Adjusted |
$ 48,298 |
92.7% |
$ 225,378 |
$ 83,968 |
$ — |
$ 11,527 |
$ 29,968 |
11.6% |
|
|||||||||||||||
RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION |
|||||||||||||||
CERTAIN LINE ITEMS - FOR THE YEAR ENDED |
|||||||||||||||
(In thousands, except percentages) |
|||||||||||||||
(Unaudited) |
|||||||||||||||
Year ended |
|||||||||||||||
Cost of |
Gross |
Selling, general |
Research and |
Intangible |
Interest |
Income tax |
Effective tax |
||||||||
GAAP Reported |
$ 440,760 |
85.7% |
$ 1,451,683 |
$ 505,748 |
$ 525,769 |
|
|
N/A (1) |
|||||||
Non-GAAP Adjustments: |
|||||||||||||||
Intangible asset amortization |
— |
— |
— |
— |
(525,769) |
— |
— |
— |
|||||||
Share-based compensation |
(10,591) |
0.3 |
(117,673) |
(41,657) |
— |
— |
— |
— |
|||||||
Transaction and integration |
(1,683) |
0.1 |
(228,962) |
(13,065) |
— |
— |
— |
— |
|||||||
Non-cash interest expense |
— |
— |
— |
— |
— |
(92,655) |
— |
— |
|||||||
Acquisition accounting |
(223,085) |
7.2 |
— |
— |
— |
— |
— |
— |
|||||||
Income tax effect of above |
— |
— |
— |
— |
— |
— |
192,521 |
N/A (1) |
|||||||
Impact of |
— |
— |
— |
— |
— |
— |
(259,873) |
N/A (1) |
|||||||
Total of non-GAAP |
(235,359) |
7.6 |
(346,635) |
(54,722) |
(525,769) |
(92,655) |
(67,352) |
N/A (1) |
|||||||
Non-GAAP Adjusted |
$ 205,401 |
93.3% |
$ 1,105,048 |
$ 451,026 |
$ — |
|
|
13.0% |
__________________________ |
(1) Due to the impact of the |
Year ended |
|||||||||||||||||
Cost of |
Gross |
Selling, general |
Research |
Intangible |
Impairment |
Interest |
Income tax |
Effective |
|||||||||
GAAP Reported |
$ 148,917 |
93.7% |
$ 854,233 |
$ 335,375 |
$ 259,580 |
$ 136,139 |
|
$ 33,517 |
12.2% |
||||||||
Non-GAAP Adjustments: |
|||||||||||||||||
Intangible asset |
— |
— |
— |
— |
(259,580) |
— |
— |
— |
— |
||||||||
Share-based compensation |
(7,372) |
0.3 |
(84,384) |
(29,242) |
— |
— |
— |
— |
— |
||||||||
Impairment charge |
— |
— |
— |
— |
— |
(136,139) |
— |
— |
— |
||||||||
Non-cash interest expense |
— |
— |
— |
— |
— |
— |
(61,134) |
— |
— |
||||||||
Income tax effect of above |
— |
— |
— |
— |
— |
— |
— |
112,491 |
4.9 |
||||||||
Total of non-GAAP |
(7,372) |
0.3 |
(84,384) |
(29,242) |
(259,580) |
(136,139) |
(61,134) |
112,491 |
4.9 |
||||||||
Non-GAAP Adjusted |
$ 141,545 |
94.0% |
$ 769,849 |
$ 306,133 |
$ — |
$ — |
|
$ 146,008 |
17.1% |
|
|
RECONCILIATION OF PRO FORMA GAAP NET LOSS TO PRO FORMA NON-GAAP ADJUSTED EBITDA AND |
|
CALCULATION OF PRO FORMA NON-GAAP NET LEVERAGE RATIO |
|
(In thousands, except ratio) |
|
(Unaudited) |
|
The following table provides a reconciliation of the Company's pro forma GAAP net loss to pro forma non-GAAP Adjusted EBITDA (calculated in accordance with the Credit Agreement) for the last twelve months, or LTM, ended |
|
LTM Ended |
|
Pro forma GAAP net loss2 |
$ (518,254) |
Interest expense, net |
278,990 |
Income tax expense |
214,976 |
Depreciation and amortization |
557,644 |
Pro forma non-GAAP EBITDA |
533,356 |
Transaction and integration related expenses |
420,884 |
Share-based compensation expense |
189,632 |
Acquisition accounting inventory fair value step-up |
223,085 |
Expected cost synergies3 |
45,000 |
Upfront and milestone payments |
15,000 |
Other |
(2,657) |
Pro forma non-GAAP Adjusted EBITDA1 |
$ 1,424,300 |
At 2021 |
|
Calculation of Net Debt: |
|
Total GAAP debt |
$ 6,395,458 |
Impact of current hedging arrangements on Euro Term Loan B |
15,052 |
Total Adjusted Debt4 |
6,410,510 |
Cash and cash equivalents |
(591,448) |
Net Debt |
$ 5,819,062 |
Calculation of Pro Forma Non-GAAP Net Leverage Ratio: |
|
Pro forma non-GAAP Net Leverage Ratio |
4.1 |
____________________________________ |
|
1. |
Pro forma non-GAAP Adjusted EBITDA is calculated in accordance with the definition of Consolidated Adjusted EBITDA as set out in the Credit Agreement. |
2. |
Pro forma net loss is derived from the GAAP financial statements of the Company and |
3. |
The Company expects to implement initiatives to achieve at least |
4. |
Total Adjusted Debt, reflects the impact of the Company's current hedging arrangements on the Euro term loan B, in accordance with the Credit Agreement. |
|
|
RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED 2022 NET INCOME GUIDANCE |
|
(In millions, except per share amounts) |
|
(Unaudited) |
|
GAAP net income |
|
Intangible asset amortization |
620 - 660 |
Acquisition accounting inventory fair value step-up |
305 - 340 |
Share-based compensation expense |
220 - 250 |
Transaction and integration related expenses |
35 - 45 |
Non-cash interest expense |
45 - 55 |
Income tax effect of above adjustments |
(210) - (230) |
Non-GAAP adjusted net income |
|
GAAP net income per diluted share |
|
Non-GAAP adjusted net income per diluted share |
|
Weighted-average ordinary shares used in per share calculations - GAAP and Non-GAAP |
721 |
1 Non-GAAP adjusted EPS guidance for 2022 reflects dilution of approximately |
Contacts:
Investors:
Vice President, Head, Investor Relations
InvestorInfo@jazzpharma.com
Media:
Head of
CorporateAffairsMediaInfo@jazzpharma.com
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