Horizon Therapeutics plc (Nasdaq: HZNP) today announced record second-quarter 2020 financial results. The Company increased its full-year 2020 net sales and adjusted EBITDA guidance on continued strength of TEPEZZA. In addition to increasing TEPEZZA full-year 2020 net sales guidance, the Company also increased its peak U.S. annual net sales estimate for the medicine.
"Driving our record second-quarter performance was the continued tremendous patient and physician response to TEPEZZA, along with our outstanding commercial execution, making the TEPEZZA launch one of the most successful rare disease medicine launches ever, despite a challenging COVID-19 environment," said Tim Walbert, chairman, president and chief executive officer, Horizon. "With TEPEZZA results having once again dramatically exceeded expectations, we increased both our TEPEZZA and Company full-year net sales guidance, as well as increased our TEPEZZA peak U.S. annual net sales estimate. We also continued to advance our clinical programs and improve our capital structure during the quarter. With our strong track record of strategic execution and driving value for patients and shareholders alike, Horizon is well positioned for long-term growth and success."
Financial Highlights
|
|
|
|
% |
|
|
|
|
|
% |
|||||||||||
(in millions except for per share amounts and percentages) | Q2 20 |
|
Q2 19 |
|
Change |
|
YTD 20 |
|
YTD 19 |
|
Change |
||||||||||
Net sales | $ |
462.8 |
|
$ |
320.6 |
|
44 |
|
$ |
818.7 |
|
$ |
601.0 |
|
36 |
||||||
Net loss |
|
(80.0 |
) |
|
(5.1 |
) |
NM |
|
|
(93.6 |
) |
|
(38.0 |
) |
146 |
||||||
Non-GAAP net income |
|
83.8 |
|
|
95.6 |
|
(12 |
) |
|
167.0 |
|
|
149.6 |
|
12 |
||||||
Adjusted EBITDA |
|
190.7 |
|
|
124.1 |
|
54 |
|
|
297.9 |
|
|
212.5 |
|
40 |
||||||
Loss per share - diluted |
|
(0.42 |
) |
|
(0.03 |
) |
NM |
|
|
(0.49 |
) |
|
(0.21 |
) |
133 |
||||||
Non-GAAP earnings per share - diluted |
|
0.40 |
|
|
0.49 |
|
(18 |
) |
|
0.80 |
|
|
0.80 |
|
- |
Second-Quarter and Recent Company Highlights
Key Research and Development Programs
Second-Quarter Financial Results
Note: For additional detail and reconciliation of non-GAAP financial measures to the most directly comparable GAAP financial measures, please refer to the tables at the end of this release.
Second-Quarter Segment Results
Management uses net sales and segment operating income to evaluate the performance of the Company's two segments, the orphan segment and the inflammation segment. While segment operating income contains certain adjustments to the directly comparable GAAP figures in the Company's consolidated financial results, it is considered to be prepared in accordance with GAAP for purposes of presenting the Company's segment operating results.
Orphan Segment |
||||||||||||||||||
|
|
|
|
% |
|
|
|
|
|
% |
||||||||
(in millions except for percentages) | Q2 20 |
|
Q2 19 |
|
Change |
|
YTD 20 |
|
YTD 19 |
|
Change |
|||||||
TEPEZZA® |
|
165.9 |
|
- |
NM |
|
|
189.4 |
|
- |
NM |
|
||||||
KRYSTEXXA® |
|
75.2 |
|
79.8 |
(6 |
) |
|
168.5 |
|
132.1 |
28 |
|
||||||
RAVICTI® |
|
65.6 |
|
50.4 |
30 |
|
|
126.7 |
|
100.3 |
26 |
|
||||||
PROCYSBI® |
|
41.4 |
|
41.2 |
- |
|
|
79.7 |
|
80.7 |
(1 |
) |
||||||
ACTIMMUNE® |
|
28.3 |
|
29.3 |
(3 |
) |
|
54.8 |
|
51.0 |
7 |
|
||||||
BUPHENYL® |
|
2.8 |
|
2.3 |
20 |
|
|
5.2 |
|
5.2 |
- |
|
||||||
QUINSAIRTM |
|
0.1 |
|
0.2 |
(65 |
) |
|
0.3 |
|
0.4 |
(1 |
) |
||||||
Orphan Net Sales | $ |
379.3 |
$ |
203.2 |
87 |
|
$ |
624.6 |
$ |
369.7 |
69 |
|
||||||
Orphan Segment Operating Income | $ |
151.5 |
$ |
63.7 |
138 |
|
$ |
205.9 |
$ |
100.4 |
105 |
|
Inflammation Segment |
||||||||||||||||||
(in millions except for percentages) | Q2 20 | Q2 19 | % Change |
YTD 20 | YTD 19 | % Change |
||||||||||||
PENNSAID 2%® |
|
35.0 |
|
51.5 |
(32 |
) |
|
76.6 |
|
101.7 |
(25 |
) |
||||||
DUEXIS® |
|
27.8 |
|
30.0 |
(8 |
) |
|
59.1 |
|
59.5 |
(1 |
) |
||||||
RAYOS® |
|
14.5 |
|
20.3 |
(29 |
) |
|
32.7 |
|
39.7 |
(18 |
) |
||||||
VIMOVO®(1) |
|
6.2 |
|
14.6 |
(57 |
) |
|
25.7 |
|
28.6 |
(10 |
) |
||||||
MIGERGOT®(2) |
|
- |
|
1.0 |
NM |
|
|
- |
|
1.8 |
NM |
|
||||||
Inflammation Net Sales | $ |
83.5 |
$ |
117.4 |
(29 |
) |
$ |
194.1 |
$ |
231.3 |
(16 |
) |
||||||
Inflammation Segment Operating Income | $ |
38.1 |
$ |
60.5 |
(37 |
) |
$ |
90.0 |
$ |
111.9 |
(20 |
) |
(1) |
On Feb. 27, 2020, Dr. Reddy's Laboratory initiated an at-risk launch of generic VIMOVO in the United States. |
|
(2) |
In June 2019, the Company divested the rights to MIGERGOT. |
Cash Flow Statement and Balance Sheet Highlights
Revised 2020 Guidance
The Company now expects full-year 2020 net sales to range between $1.85 billion to $1.90 billion, an increase from the previous guidance range of $1.40 billion to $1.45 billion. The Company now expects TEPEZZA full-year 2020 net sales of greater than $650 million, compared to the previous guidance of greater than $200 million. Full-year 2020 adjusted EBITDA is now expected to range between $725 million and $775 million, an increase from the previous guidance range of $450 million to $500 million.
Webcast
At 8 a.m. EST / 1 p.m. IST today, the Company will host a live webcast to review its financial and operating results and provide a general business update. The live webcast and a replay may be accessed at http://ir.horizontherapeutics.com. Please connect to the Company's website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. A replay of the webcast will be available approximately two hours after the live webcast.
About Horizon
Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.
Note Regarding Use of Non-GAAP Financial Measures
EBITDA, or earnings before interest, taxes, depreciation and amortization, and adjusted EBITDA are used and provided by Horizon as non-GAAP financial measures. Horizon provides certain other financial measures such as non-GAAP net income, non-GAAP diluted earnings per share, non-GAAP gross profit and gross profit ratio, non-GAAP operating expenses, non-GAAP operating income, non-GAAP tax rate, non-GAAP operating cash flow, net leverage ratio and net debt, each of which include adjustments to GAAP figures. These non-GAAP measures are intended to provide additional information on Horizon's performance, operations, expenses, profitability and cash flows. Adjustments to Horizon's GAAP figures as well as EBITDA exclude acquisition and/or divestiture-related expenses, charges related to the discontinuation of ACTIMMUNE development for Friedreich's ataxia, gain or loss from divestiture, gain or loss from sale of assets, upfront, progress and milestone payments related to license and collaboration agreements, litigation settlements, loss on debt extinguishment, costs of debt refinancing, drug manufacturing harmonization costs, restructuring and realignment costs, the income tax effect on pre-tax non-GAAP adjustments and other non-GAAP income tax adjustments, as well as non-cash items such as share-based compensation, depreciation and amortization, non-cash interest expense, long-lived asset impairment charges and other non-cash adjustments. Certain other special items or substantive events may also be included in the non-GAAP adjustments periodically when their magnitude is significant within the periods incurred. Horizon maintains an established non-GAAP cost policy that guides the determination of what costs will be excluded in non-GAAP measures. Horizon believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Horizon's financial and operating performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of the Company's historical and expected 2020 financial results and trends and to facilitate comparisons between periods and with respect to projected information. In addition, these non-GAAP financial measures are among the indicators Horizon's management uses for planning and forecasting purposes and measuring the Company's performance. For example, adjusted EBITDA is used by Horizon as one measure of management performance under certain incentive compensation arrangements. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. Horizon has not provided a reconciliation of its full-year 2020 adjusted EBITDA outlook to an expected net income (loss) outlook because certain items such as acquisition/divestiture-related expenses and share-based compensation that are a component of net income (loss) cannot be reasonably projected due to the significant impact of changes in Horizon's stock price, the variability associated with the size or timing of acquisitions/divestitures and other factors. These components of net income (loss) could significantly impact Horizon's actual net income (loss).
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to Horizon's full-year 2020 net sales and adjusted EBITDA guidance; expected financial performance and operating results in future periods, including potential growth in net sales of certain of Horizon's medicines; development plans; expected timing of clinical trials, studies and regulatory submissions; potential market opportunity for and benefits of Horizon's medicines and medicine candidates; and business and other statements that are not historical facts. These forward-looking statements are based on Horizon's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks that Horizon's actual future financial and operating results may differ from its expectations or goals; Horizon's ability to grow net sales from existing medicines; impacts of the COVID-19 pandemic and actions taken to slow its spread, including impacts on net sales of Horizon's medicines and potential delays in clinical trials; the availability of coverage and adequate reimbursement and pricing from government and third-party payers; risks relating to Horizon's ability to successfully implement its business strategies; risks inherent in developing novel medicine candidates and existing medicines for new indications; risks associated with regulatory approvals; risks in the ability to recruit, train and retain qualified personnel; competition, including potential generic competition; the ability to protect intellectual property and defend patents; regulatory obligations and oversight, including any changes in the legal and regulatory environment in which Horizon operates and those risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in Horizon's filings and reports with the SEC. Horizon undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information.
Horizon Therapeutics plc |
||||||||||||||||
Condensed Consolidated Statements of Operations (Unaudited) |
||||||||||||||||
(in thousands, except share and per share data) |
||||||||||||||||
Three Months Ended June 30, |
|
Six Months Ended June 30, |
||||||||||||||
2020 |
|
2019 |
|
2020 |
|
2019 |
||||||||||
Net sales | $ |
462,779 |
|
$ |
320,647 |
|
$ |
818,688 |
|
$ |
601,018 |
|
||||
Cost of goods sold |
|
121,515 |
|
|
89,163 |
|
|
218,931 |
|
|
177,305 |
|
||||
Gross profit |
|
341,264 |
|
|
231,484 |
|
|
599,757 |
|
|
423,713 |
|
||||
OPERATING EXPENSES: | ||||||||||||||||
Research and development |
|
81,068 |
|
|
28,314 |
|
|
108,277 |
|
|
50,039 |
|
||||
Selling, general and administrative |
|
222,332 |
|
|
167,095 |
|
|
470,107 |
|
|
339,394 |
|
||||
Loss on sale of assets |
|
- |
|
|
10,963 |
|
|
- |
|
|
10,963 |
|
||||
Total operating expenses |
|
303,400 |
|
|
206,372 |
|
|
578,384 |
|
|
400,396 |
|
||||
Operating income |
|
37,864 |
|
|
25,112 |
|
|
21,373 |
|
|
23,317 |
|
||||
OTHER EXPENSE, NET: | ||||||||||||||||
Interest expense, net |
|
(18,571 |
) |
|
(22,033 |
) |
|
(35,915 |
) |
|
(49,563 |
) |
||||
Loss on debt extinguishment |
|
(17,254 |
) |
|
(11,878 |
) |
|
(17,254 |
) |
|
(17,464 |
) |
||||
Foreign exchange gain |
|
283 |
|
|
76 |
|
|
1,059 |
|
|
15 |
|
||||
Other income (expense), net |
|
632 |
|
|
(1,272 |
) |
|
1,074 |
|
|
(1,083 |
) |
||||
Total other expense, net |
|
(34,910 |
) |
|
(35,107 |
) |
|
(51,036 |
) |
|
(68,095 |
) |
||||
Income (Loss) before expense (benefit) for income taxes |
|
2,954 |
|
|
(9,995 |
) |
|
(29,663 |
) |
|
(44,778 |
) |
||||
Expense (benefit) for income taxes |
|
82,964 |
|
|
(4,875 |
) |
|
63,938 |
|
|
(6,795 |
) |
||||
Net loss | $ |
(80,010 |
) |
$ |
(5,120 |
) |
$ |
(93,601 |
) |
$ |
(37,983 |
) |
||||
Net loss per ordinary share - basic and diluted | $ |
(0.42 |
) |
$ |
(0.03 |
) |
$ |
(0.49 |
) |
$ |
(0.21 |
) |
||||
Weighted average ordinary shares outstanding - basic and diluted |
|
192,705,535 |
|
|
185,327,383 |
|
|
191,426,864 |
|
|
178,866,391 |
|
Horizon Therapeutics plc |
||||||||||||
Condensed Consolidated Balance Sheets (Unaudited) |
||||||||||||
(in thousands, except share data) |
||||||||||||
As of | ||||||||||||
June 30, 2020 |
December 31, 2019 |
|||||||||||
ASSETS | ||||||||||||
CURRENT ASSETS: | ||||||||||||
Cash and cash equivalents | $ |
718,062 |
|
$ |
1,076,287 |
|
||||||
Restricted cash |
|
3,625 |
|
|
3,752 |
|
||||||
Accounts receivable, net |
|
543,755 |
|
|
408,685 |
|
||||||
Inventories, net |
|
66,099 |
|
|
53,802 |
|
||||||
Prepaid expenses and other current assets |
|
157,548 |
|
|
143,577 |
|
||||||
Total current assets |
|
1,489,089 |
|
|
1,686,103 |
|
||||||
Property and equipment, net |
|
138,801 |
|
|
30,159 |
|
||||||
Developed technology and other intangible assets, net |
|
1,891,100 |
|
|
1,702,628 |
|
||||||
Goodwill |
|
413,669 |
|
|
413,669 |
|
||||||
Deferred tax assets, net |
|
564,643 |
|
|
555,165 |
|
||||||
Other assets |
|
40,889 |
|
|
48,310 |
|
||||||
Total assets | $ |
4,538,191 |
|
$ |
4,436,034 |
|
||||||
LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||||||
CURRENT LIABILITIES: | ||||||||||||
Exchangeable Senior Notes?current | $ |
174,504 |
|
$ |
- |
|
||||||
Accounts payable |
|
106,015 |
|
|
21,514 |
|
||||||
Accrued expenses |
|
415,545 |
|
|
235,234 |
|
||||||
Accrued trade discounts and rebates |
|
288,592 |
|
|
466,421 |
|
||||||
Total current liabilities |
|
984,656 |
|
|
723,169 |
|
||||||
LONG-TERM LIABILITIES: | ||||||||||||
Exchangeable Senior Notes, net |
|
- |
|
|
351,533 |
|
||||||
Long-term debt, net |
|
1,002,318 |
|
|
1,001,308 |
|
||||||
Deferred tax liabilities, net |
|
99,164 |
|
|
94,247 |
|
||||||
Other long-term liabilities |
|
90,201 |
|
|
80,328 |
|
||||||
Total long-term liabilities |
|
1,191,683 |
|
|
1,527,416 |
|
||||||
COMMITMENTS AND CONTINGENCIES | ||||||||||||
SHAREHOLDERS' EQUITY: | ||||||||||||
Ordinary shares, $0.0001 nominal value; 600,000,000 shares authorized at June 30, 2020 and December 31, 2019; 199,991,807 and 188,402,040 shares issued at June 30, 2020 and December 31, 2019, respectively, and 199,607,441 and 188,017,674 shares outstanding at June 30, 2020 and December 31, 2019, respectively |
|
20 |
|
|
19 |
|
||||||
Treasury stock, 384,366 ordinary shares at June 30, 2020 and December 31, 2019 |
|
(4,585 |
) |
|
(4,585 |
) |
||||||
Additional paid-in capital |
|
3,067,586 |
|
|
2,797,602 |
|
||||||
Accumulated other comprehensive loss |
|
(1,886 |
) |
|
(1,905 |
) |
||||||
Accumulated deficit |
|
(699,283 |
) |
|
(605,682 |
) |
||||||
Total shareholders' equity |
|
2,361,852 |
|
|
2,185,449 |
|
||||||
Total liabilities and shareholders' equity | $ |
4,538,191 |
|
$ |
4,436,034 |
|
Horizon Therapeutics plc |
|||||||||||||||||||
Condensed Consolidated Statements of Cash Flows (Unaudited) |
|||||||||||||||||||
(in thousands) |
|||||||||||||||||||
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|||||||||||||||||
2020 |
|
2019 |
|
2020 |
|
2019 |
|||||||||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | |||||||||||||||||||
Net loss | $ |
(80,010 |
) |
$ |
(5,120 |
) |
$ |
(93,601 |
) |
$ |
(37,983 |
) |
|||||||
Adjustments to reconcile net loss to net cash provided by operating activities: | |||||||||||||||||||
Depreciation and amortization expense |
|
73,655 |
|
|
59,126 |
|
|
139,396 |
|
|
118,017 |
|
|||||||
Equity-settled share-based compensation |
|
27,057 |
|
|
21,367 |
|
|
83,478 |
|
|
48,915 |
|
|||||||
Acquired in-process research and development expense |
|
47,517 |
|
|
- |
|
|
47,517 |
|
|
- |
|
|||||||
Loss on debt extinguishment |
|
17,254 |
|
|
11,878 |
|
|
17,254 |
|
|
17,464 |
|
|||||||
Amortization of debt discount and deferred financing costs |
|
5,248 |
|
|
5,771 |
|
|
10,817 |
|
|
11,622 |
|
|||||||
Loss on sale of assets |
|
- |
|
|
10,963 |
|
|
- |
|
|
10,963 |
|
|||||||
Deferred income taxes |
|
(2,479 |
) |
|
(2,759 |
) |
|
(4,561 |
) |
|
(1,257 |
) |
|||||||
Foreign exchange and other adjustments |
|
851 |
|
|
84 |
|
|
661 |
|
|
493 |
|
|||||||
Changes in operating assets and liabilities: | |||||||||||||||||||
Accounts receivable |
|
(118,256 |
) |
|
9,019 |
|
|
(135,125 |
) |
|
69,787 |
|
|||||||
Inventories |
|
2,101 |
|
|
343 |
|
|
(12,343 |
) |
|
(504 |
) |
|||||||
Prepaid expenses and other current assets |
|
4,543 |
|
|
(17,807 |
) |
|
(20,410 |
) |
|
(17,696 |
) |
|||||||
Accounts payable |
|
55,004 |
|
|
5,138 |
|
|
83,555 |
|
|
11,554 |
|
|||||||
Accrued trade discounts and rebates |
|
(47,781 |
) |
|
(8,247 |
) |
|
(177,721 |
) |
|
(59,151 |
) |
|||||||
Accrued expenses |
|
109,592 |
|
|
(6,736 |
) |
|
81,505 |
|
|
(28,071 |
) |
|||||||
Deferred revenues |
|
- |
|
|
2,477 |
|
|
- |
|
|
2,410 |
|
|||||||
Other non-current assets and liabilities |
|
5,305 |
|
|
5,770 |
|
|
16,586 |
|
|
873 |
|
|||||||
Net cash provided by operating activities |
|
99,601 |
|
|
91,267 |
|
|
37,008 |
|
|
147,436 |
|
|||||||
CASH FLOWS FROM INVESTING ACTIVITIES: | |||||||||||||||||||
Proceeds from sale of assets |
|
- |
|
|
6,000 |
|
|
- |
|
|
6,000 |
|
|||||||
Payments for acquisitions |
|
(157,105 |
) |
|
- |
|
|
(262,305 |
) |
|
- |
|
|||||||
Change in escrow deposit for property purchase |
|
- |
|
|
- |
|
|
6,000 |
|
|
- |
|
|||||||
Purchases of property and equipment |
|
(966 |
) |
|
(5,009 |
) |
|
(119,970 |
) |
|
(6,858 |
) |
|||||||
Net cash (used in) provided by investing activities |
|
(158,071 |
) |
|
991 |
|
|
(376,275 |
) |
|
(858 |
) |
|||||||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||||||||||||||||||
Repayment of senior notes |
|
- |
|
|
(258,282 |
) |
|
- |
|
|
(258,282 |
) |
|||||||
Net proceeds from the issuance of ordinary shares |
|
- |
|
|
(957 |
) |
|
- |
|
|
326,793 |
|
|||||||
Repayment of term loans |
|
- |
|
|
(518,026 |
) |
|
- |
|
|
(818,026 |
) |
|||||||
Net proceeds from term loans |
|
- |
|
|
517,378 |
|
|
- |
|
|
517,378 |
|
|||||||
Proceeds from the issuance of ordinary shares in conjunction with ESPP program |
|
7,979 |
|
|
5,465 |
|
|
7,979 |
|
|
5,465 |
|
|||||||
Proceeds from the issuance of ordinary shares in connection with stock option exercises |
|
18,837 |
|
|
1,987 |
|
|
25,887 |
|
|
12,029 |
|
|||||||
Payment of employee withholding taxes relating to share-based awards |
|
(6,345 |
) |
|
(7,203 |
) |
|
(53,009 |
) |
|
(24,374 |
) |
|||||||
Net cash provided by (used in) financing activities |
|
20,471 |
|
|
(259,638 |
) |
|
(19,143 |
) |
|
(239,017 |
) |
|||||||
Effect of foreign exchange rate changes on cash, cash equivalents and restricted cash |
|
1,424 |
|
|
576 |
|
|
58 |
|
|
58 |
|
|||||||
Net decrease in cash, cash equivalents and restricted cash |
|
(36,575 |
) |
|
(166,804 |
) |
|
(358,352 |
) |
|
(92,381 |
) |
|||||||
Cash, cash equivalents and restricted cash, beginning of the period(1) |
|
758,262 |
|
|
1,036,540 |
|
|
1,080,039 |
|
|
962,117 |
|
|||||||
Cash, cash equivalents and restricted cash, end of the period(1) | $ |
721,687 |
|
$ |
869,736 |
|
$ |
721,687 |
|
$ |
869,736 |
|
(1) |
Amounts include restricted cash balance in accordance with ASU No. 2016-18. Cash and cash equivalents excluding restricted cash are shown on the balance sheet. |
Horizon Therapeutics plc | ||||||||||||||||
GAAP to Non-GAAP Reconciliations | ||||||||||||||||
Net Income and Earnings Per Share (Unaudited) | ||||||||||||||||
(in thousands, except share and per share data) | ||||||||||||||||
Three Months Ended June 30, |
|
Six Months Ended June 30, |
||||||||||||||
2020 |
|
2019 |
|
2020 |
|
2019 |
||||||||||
GAAP net loss | $ |
(80,010 |
) |
$ |
(5,120 |
) |
$ |
(93,601 |
) |
$ |
(37,983 |
) |
||||
Non-GAAP adjustments: | ||||||||||||||||
Acquisition/divestiture-related costs |
|
47,103 |
|
|
1,200 |
|
|
47,097 |
|
|
2,546 |
|
||||
Restructuring and realignment costs |
|
- |
|
|
13 |
|
|
- |
|
|
33 |
|
||||
Amortization and step-up: | ||||||||||||||||
Intangible amortization expense |
|
66,749 |
|
|
57,683 |
|
|
125,324 |
|
|
115,100 |
|
||||
Inventory step-up expense |
|
- |
|
|
(25 |
) |
|
- |
|
|
90 |
|
||||
Amortization of debt discount and deferred financing costs |
|
5,248 |
|
|
5,710 |
|
|
10,817 |
|
|
11,622 |
|
||||
Impairment of long-lived assets |
|
1,072 |
|
|
- |
|
|
1,072 |
|
|
- |
|
||||
Loss on sale of assets |
|
- |
|
|
10,963 |
|
|
- |
|
|
10,963 |
|
||||
Share-based compensation |
|
27,057 |
|
|
21,367 |
|
|
83,478 |
|
|
48,915 |
|
||||
Depreciation |
|
6,907 |
|
|
1,443 |
|
|
14,072 |
|
|
2,916 |
|
||||
Litigation settlements |
|
- |
|
|
1,000 |
|
|
- |
|
|
1,000 |
|
||||
Upfront, progress and milestone payments related to license and collaboration agreements |
|
3,000 |
|
|
4,000 |
|
|
3,000 |
|
|
6,000 |
|
||||
Fees related to refinancing activities |
|
- |
|
|
1,033 |
|
|
54 |
|
|
1,175 |
|
||||
Loss on debt extinguishment |
|
17,254 |
|
|
11,878 |
|
|
17,254 |
|
|
17,464 |
|
||||
Drug substance harmonization costs |
|
- |
|
|
234 |
|
|
290 |
|
|
314 |
|
||||
Charges relating to discontinuation of Friedreich's ataxia program |
|
- |
|
|
1,300 |
|
|
- |
|
|
1,221 |
|
||||
Total of pre-tax non-GAAP adjustments |
|
174,390 |
|
|
117,799 |
|
|
302,458 |
|
|
219,359 |
|
||||
Income tax effect of pre-tax non-GAAP adjustments |
|
(25,797 |
) |
|
(15,621 |
) |
|
(57,059 |
) |
|
(30,372 |
) |
||||
Other non-GAAP income tax adjustments |
|
15,210 |
|
|
(1,452 |
) |
|
15,210 |
|
|
(1,452 |
) |
||||
Total of non-GAAP adjustments |
|
163,803 |
|
|
100,726 |
|
|
260,609 |
|
|
187,535 |
|
||||
Non-GAAP Net Income | $ |
83,793 |
|
$ |
95,606 |
|
$ |
167,008 |
|
$ |
149,552 |
|
||||
Non-GAAP Earnings Per Share: | ||||||||||||||||
Weighted average ordinary shares - Basic |
|
192,705,535 |
|
|
185,327,383 |
|
|
191,426,864 |
|
|
178,866,391 |
|
||||
Non-GAAP Earnings Per Share - Basic: | ||||||||||||||||
GAAP loss per share - Basic | $ |
(0.42 |
) |
$ |
(0.03 |
) |
$ |
(0.49 |
) |
$ |
(0.21 |
) |
||||
Non-GAAP adjustments |
|
0.85 |
|
|
0.55 |
|
|
1.36 |
|
|
1.05 |
|
||||
Non-GAAP earnings per share - Basic | $ |
0.43 |
|
$ |
0.52 |
|
$ |
0.87 |
|
$ |
0.84 |
|
||||
Non-GAAP Net Income | $ |
83,793 |
|
$ |
95,606 |
|
$ |
167,008 |
|
$ |
149,552 |
|
||||
Effect of assumed exchange of Exchangeable Senior Notes, net of tax |
|
1,692 |
|
|
- |
|
|
3,567 |
|
|
- |
|
||||
Numerator - non-GAAP Net Income | $ |
85,485 |
|
$ |
95,606 |
|
$ |
170,575 |
|
$ |
149,552 |
|
||||
Weighted average ordinary shares - Diluted | ||||||||||||||||
Weighted average ordinary shares - Basic |
|
192,705,535 |
|
|
185,327,383 |
|
|
191,426,864 |
|
|
178,866,391 |
|
||||
Ordinary share equivalents |
|
21,838,670 |
|
|
7,897,507 |
|
|
22,084,476 |
|
|
7,658,133 |
|
||||
Denominator - weighted average ordinary shares ? Diluted |
|
214,544,205 |
|
|
193,224,890 |
|
|
213,511,340 |
|
|
186,524,524 |
|
||||
Non-GAAP Earnings Per Share - Diluted | ||||||||||||||||
GAAP loss per share - Diluted |
|
(0.42 |
) |
|
(0.03 |
) |
|
(0.49 |
) |
|
(0.21 |
) |
||||
Non-GAAP adjustments |
|
0.85 |
|
|
0.55 |
|
|
1.36 |
|
|
1.05 |
|
||||
Diluted earnings per share effect of ordinary share equivalents |
|
(0.03 |
) |
|
(0.03 |
) |
|
(0.07 |
) |
|
(0.04 |
) |
||||
Non-GAAP earnings per share - Diluted | $ |
0.40 |
|
$ |
0.49 |
|
$ |
0.80 |
|
$ |
0.80 |
|
Horizon Therapeutics plc |
||||||||||||||||||
GAAP to Non-GAAP Reconciliations |
||||||||||||||||||
EBITDA (Unaudited) |
||||||||||||||||||
(in thousands) |
||||||||||||||||||
Three Months Ended June 30, |
|
Six Months Ended June 30, |
||||||||||||||||
2020 |
|
2019 |
|
2020 |
|
2019 |
||||||||||||
GAAP net loss | $ |
(80,010 |
) |
$ |
(5,120 |
) |
$ |
(93,601 |
) |
$ |
(37,983 |
) |
||||||
Depreciation |
|
6,907 |
|
|
1,443 |
|
|
14,072 |
|
|
2,916 |
|
||||||
Amortization and step-up: | ||||||||||||||||||
Intangible amortization expense |
|
66,749 |
|
|
57,683 |
|
|
125,324 |
|
|
115,100 |
|
||||||
Inventory step-up expense |
|
- |
|
|
(25 |
) |
|
- |
|
|
90 |
|
||||||
Interest expense, net (including amortization of debt discount and deferred financing costs) |
|
18,571 |
|
|
22,033 |
|
|
35,915 |
|
|
49,563 |
|
||||||
Expense (benefit) for income taxes |
|
82,964 |
|
|
(4,875 |
) |
|
63,938 |
|
|
(6,795 |
) |
||||||
EBITDA | $ |
95,181 |
|
$ |
71,139 |
|
$ |
145,648 |
|
$ |
122,891 |
|
||||||
Other non-GAAP adjustments: | ||||||||||||||||||
Acquisition/divestiture-related costs |
|
47,103 |
|
|
1,200 |
|
|
47,097 |
|
|
2,546 |
|
||||||
Restructuring and realignment costs |
|
- |
|
|
13 |
|
|
- |
|
|
33 |
|
||||||
Impairment of long-lived assets |
|
1,072 |
|
|
- |
|
|
1,072 |
|
|
- |
|
||||||
Loss on sale of assets |
|
- |
|
|
10,963 |
|
|
- |
|
|
10,963 |
|
||||||
Share-based compensation |
|
27,057 |
|
|
21,367 |
|
|
83,478 |
|
|
48,915 |
|
||||||
Litigation settlements |
|
- |
|
|
1,000 |
|
|
- |
|
|
1,000 |
|
||||||
Upfront, progress and milestone payments related to license and collaboration agreements |
|
3,000 |
|
|
4,000 |
|
|
3,000 |
|
|
6,000 |
|
||||||
Fees related to refinancing activities |
|
- |
|
|
1,033 |
|
|
54 |
|
|
1,175 |
|
||||||
Loss on debt extinguishment |
|
17,254 |
|
|
11,878 |
|
|
17,254 |
|
|
17,464 |
|
||||||
Drug substance harmonization costs |
|
- |
|
|
234 |
|
|
290 |
|
|
314 |
|
||||||
Charges relating to discontinuation of Friedreich's ataxia program |
|
- |
|
|
1,300 |
|
|
- |
|
|
1,221 |
|
||||||
Total of other non-GAAP adjustments |
|
95,486 |
|
|
52,988 |
|
|
152,245 |
|
|
89,631 |
|
||||||
Adjusted EBITDA | $ |
190,667 |
|
$ |
124,127 |
|
$ |
297,893 |
|
$ |
212,522 |
|
Horizon Therapeutics plc |
||||||||||||||
GAAP to Non-GAAP Reconciliations |
||||||||||||||
Operating Income (Unaudited) |
||||||||||||||
(in thousands) |
||||||||||||||
Three Months Ended June 30, |
|
Six Months Ended June 30, |
||||||||||||
2020 |
|
2019 |
|
2020 |
|
2019 |
||||||||
GAAP operating income | $ |
37,864 |
$ |
25,112 |
|
$ |
21,373 |
$ |
23,317 |
|||||
Non-GAAP adjustments: | ||||||||||||||
Acquisition/divestiture-related costs |
|
46,988 |
|
73 |
|
|
47,272 |
|
1,275 |
|||||
Restructuring and realignment costs |
|
- |
|
13 |
|
|
- |
|
33 |
|||||
Amortization and step-up: | ||||||||||||||
Intangible amortization expense |
|
66,749 |
|
57,683 |
|
|
125,324 |
|
115,100 |
|||||
Inventory step-up expense |
|
- |
|
(25 |
) |
|
- |
|
90 |
|||||
Impairment of long-lived assets |
|
1,072 |
|
- |
|
|
1,072 |
|
- |
|||||
Loss on sale of assets |
|
- |
|
10,963 |
|
|
- |
|
10,963 |
|||||
Share-based compensation |
|
27,057 |
|
21,367 |
|
|
83,478 |
|
48,915 |
|||||
Depreciation |
|
6,907 |
|
1,443 |
|
|
14,072 |
|
2,916 |
|||||
Litigation settlements |
|
- |
|
1,000 |
|
|
- |
|
1,000 |
|||||
Upfront, progress and milestone payments related to | ||||||||||||||
license and collaboration agreements |
|
3,000 |
|
4,000 |
|
|
3,000 |
|
6,000 |
|||||
Fees related to refinancing activities |
|
- |
|
1,033 |
|
|
54 |
|
1,175 |
|||||
Drug substance harmonization costs |
|
- |
|
234 |
|
|
290 |
|
314 |
|||||
Charges relating to discontinuation of Friedreich's ataxia program |
|
- |
|
1,300 |
|
|
- |
|
1,221 |
|||||
Total of non-GAAP adjustments |
|
151,773 |
|
99,084 |
|
|
274,562 |
|
189,002 |
|||||
Non-GAAP operating income | $ |
189,637 |
$ |
124,196 |
|
$ |
295,935 |
$ |
212,319 |
|||||
Orphan segment operating income |
|
151,541 |
|
63,696 |
|
|
205,897 |
|
100,400 |
|||||
Inflammation segment operating income |
|
38,096 |
|
60,500 |
|
|
90,038 |
|
111,919 |
|||||
Total segment operating income | $ |
189,637 |
$ |
124,196 |
|
$ |
295,935 |
$ |
212,319 |
|||||
Foreign exchange gain |
|
283 |
|
76 |
|
|
1,059 |
|
15 |
|||||
Other income (expense), net |
|
747 |
|
(145 |
) |
|
899 |
|
188 |
|||||
Adjusted EBITDA | $ |
190,667 |
$ |
124,127 |
|
$ |
297,893 |
$ |
212,522 |
Horizon Therapeutics plc |
|||||||||||||||||
GAAP to Non-GAAP Reconciliations |
|||||||||||||||||
Gross Profit and Operating Cash Flow (Unaudited) |
|||||||||||||||||
(in thousands, except percentages) |
|||||||||||||||||
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|||||||||||||||
2020 |
|
2019 |
|
2020 |
|
2019 |
|||||||||||
Non-GAAP Gross Profit: | |||||||||||||||||
GAAP gross profit | $ |
341,264 |
|
$ |
231,484 |
|
$ |
599,757 |
|
$ |
423,713 |
|
|||||
Non-GAAP gross profit adjustments: | |||||||||||||||||
Acquisition/divestiture-related costs |
|
- |
|
|
- |
|
|
- |
|
|
1,114 |
|
|||||
Intangible amortization expense |
|
66,547 |
|
|
57,481 |
|
|
124,921 |
|
|
114,699 |
|
|||||
Inventory step-up expense |
|
- |
|
|
(25 |
) |
|
- |
|
|
90 |
|
|||||
Share-based compensation |
|
1,288 |
|
|
951 |
|
|
3,977 |
|
|
1,990 |
|
|||||
Depreciation |
|
90 |
|
|
158 |
|
|
418 |
|
|
317 |
|
|||||
Drug substance harmonization costs |
|
- |
|
|
234 |
|
|
290 |
|
|
314 |
|
|||||
Charges relating to discontinuation of Friedreich's ataxia program |
|
- |
|
|
1,300 |
|
|
- |
|
|
1,221 |
|
|||||
Total of Non-GAAP adjustments |
|
67,925 |
|
|
60,099 |
|
|
129,606 |
|
|
119,745 |
|
|||||
Non-GAAP gross profit | $ |
409,189 |
|
$ |
291,583 |
|
$ |
729,363 |
|
$ |
543,458 |
|
|||||
GAAP gross profit % |
|
73.7 |
% |
|
72.2 |
% |
|
73.3 |
% |
|
70.5 |
% |
|||||
Non-GAAP gross profit % |
|
88.4 |
% |
|
90.9 |
% |
|
89.1 |
% |
|
90.4 |
% |
|||||
GAAP cash provided by operating activities | $ |
99,601 |
|
$ |
91,267 |
|
$ |
37,008 |
|
$ |
147,436 |
|
|||||
Cash payments for acquisition/divestiture-related costs |
|
- |
|
|
142 |
|
|
(17 |
) |
|
495 |
|
|||||
Cash payments for restructuring and realignment costs |
|
94 |
|
|
839 |
|
|
189 |
|
|
2,882 |
|
|||||
Cash payments for upfront, progress and milestone payments related to license and collaboration agreement |
|
- |
|
|
- |
|
|
- |
|
|
2,000 |
|
|||||
Cash payments drug substance harmonization costs |
|
290 |
|
|
25 |
|
|
290 |
|
|
672 |
|
|||||
Cash payments for discontinuation of Friedreich's ataxia program |
|
- |
|
|
1,659 |
|
|
- |
|
|
2,589 |
|
|||||
Cash payments relating to refinancing activities |
|
- |
|
|
1,797 |
|
|
73 |
|
|
1,806 |
|
|||||
Non-GAAP operating cash flow | $ |
99,985 |
|
$ |
95,729 |
|
$ |
37,543 |
|
$ |
157,880 |
|
Horizon Therapeutics plc |
|||||
GAAP to Non-GAAP Reconciliations |
|||||
EBITDA (Unaudited) - 2019 |
|||||
(in thousands) |
|||||
Twelve Months
|
|||||
2019 |
|||||
GAAP net income | $ |
573,020 |
|
||
Depreciation |
|
6,733 |
|
||
Amortization and step-up: | |||||
Intangible amortization expense |
|
230,424 |
|
||
Inventory step-up expense |
|
89 |
|
||
Interest expense, net (including amortization of debt discount and deferred financing costs) |
|
87,089 |
|
||
Benefit for income taxes |
|
(593,244 |
) |
||
EBITDA | $ |
304,111 |
|
||
Other non-GAAP adjustments: | |||||
Acquisition/divestiture-related costs |
|
3,556 |
|
||
Restructuring and realignment costs |
|
237 |
|
||
Share-based compensation |
|
91,215 |
|
||
Litigation settlements |
|
1,000 |
|
||
Upfront, progress and milestone payments related to license and collaboration agreements |
|
9,073 |
|
||
Fees related to refinancing activities |
|
2,292 |
|
||
Loss on debt extinguishment |
|
58,835 |
|
||
Drug substance harmonization costs |
|
457 |
|
||
Charges relating to discontinuation of Friedreich's ataxia program |
|
1,076 |
|
||
Gain on sale of assets |
|
10,963 |
|
||
Total of other non-GAAP adjustments |
|
178,704 |
|
||
Adjusted EBITDA | $ |
482,815 |
|
Horizon Therapeutics plc |
|||||||||||||||||
Net Debt Reconciliation (Unaudited) |
|||||||||||||||||
(in thousands) |
|||||||||||||||||
As of | |||||||||||||||||
June 30, 2020 |
December 31, 2019 |
June 30, 2019 |
|||||||||||||||
Long-term debt, net | $ |
1,002,318 |
$ |
1,001,308 |
$ |
1,025,096 |
|||||||||||
Exchangeable Senior Notes, current (1) |
|
174,504 |
|
- |
|
- |
|||||||||||
Exchangeable Senior Notes, net |
|
- |
|
351,533 |
|
341,682 |
|||||||||||
Total Debt |
|
1,176,822 |
|
1,352,841 |
|
1,366,778 |
|||||||||||
Debt discount |
|
29,226 |
|
59,922 |
|
70,754 |
|||||||||||
Deferred financing fees |
|
4,934 |
|
5,263 |
|
5,494 |
|||||||||||
Total Principal Amount of Debt |
|
1,210,982 |
|
1,418,026 |
|
1,443,026 |
|||||||||||
Less: cash and cash equivalents |
|
718,062 |
|
1,076,287 |
|
865,997 |
|||||||||||
Net Debt | $ |
492,920 |
$ |
341,739 |
$ |
577,029 |
(1) |
On June 3, 2020, the Company issued a notice of redemption for all of the outstanding Exchangeable Senior Notes. During the three months ended June 30, 2020, the Company issued an aggregate of 7,225,368 of its ordinary shares to noteholders as a result of exchanges of $207.0 million in aggregate principal amount of Exchangeable Senior Notes. As of June 30, 2020, an aggregate principal amount of $193.0 million of Exchangeable Senior Notes were outstanding, which was partially offset by $18.5 million of unamortized debt discount on the consolidated balance sheet. |
Horizon Therapeutics plc |
|||||||||||||||||||
GAAP to Non-GAAP Tax Rate Reconciliation (Unaudited) |
|||||||||||||||||||
(in millions, except percentages and per share amounts) |
|||||||||||||||||||
Q2 2020 | |||||||||||||||||||
Pre-tax Net
|
Income Tax (Benefit) Expense |
Tax Rate | Net Income (Loss) |
Diluted Earnings (Loss) Per Share |
|||||||||||||||
As reported - GAAP | $ |
3.0 |
|
$ |
83.0 |
|
NM |
|
$ |
(80.0 |
) |
$ |
(0.42 |
) |
|||||
Non-GAAP adjustments |
|
174.4 |
|
|
10.6 |
|
|
148.6 |
|
||||||||||
Non-GAAP | $ |
177.3 |
|
$ |
93.6 |
|
52.8 |
% |
$ |
83.8 |
|
$ |
0.40 |
|
|||||
Q2 2019 | |||||||||||||||||||
Pre-tax Net (Loss) Income |
Income Tax (Benefit) Expense |
Tax Rate | Net Income (Loss) |
Diluted Earnings (Loss) Per Share |
|||||||||||||||
As reported - GAAP | $ |
(10.0 |
) |
$ |
(4.9 |
) |
48.8 |
% |
$ |
(5.1 |
) |
$ |
(0.03 |
) |
|||||
Non-GAAP adjustments |
|
117.8 |
|
|
17.1 |
|
|
100.7 |
|
||||||||||
Non-GAAP | $ |
107.8 |
|
$ |
12.2 |
|
11.3 |
% |
$ |
95.6 |
|
$ |
0.49 |
|
|||||
YTD 2020 | |||||||||||||||||||
Pre-tax Net (Loss) Income |
Income Tax (Benefit) Expense |
Tax Rate | Net Income (Loss) |
Diluted Earnings (Loss) Per Share |
|||||||||||||||
As reported - GAAP | $ |
(29.7 |
) |
$ |
63.9 |
|
NM |
|
$ |
(93.6 |
) |
$ |
(0.49 |
) |
|||||
Non-GAAP adjustments |
|
302.5 |
|
|
41.8 |
|
|
245.4 |
|
||||||||||
Non-GAAP | $ |
272.8 |
|
$ |
105.8 |
|
39.0 |
% |
$ |
167.0 |
|
$ |
0.80 |
|
|||||
YTD 2019 | |||||||||||||||||||
Pre-tax Net (Loss) Income |
Income Tax (Benefit) Expense |
Tax Rate | Net Income (Loss) |
Diluted Earnings (Loss) Per Share |
|||||||||||||||
As reported - GAAP | $ |
(44.8 |
) |
$ |
(6.8 |
) |
15.2 |
% |
$ |
(38.0 |
) |
$ |
(0.21 |
) |
|||||
Non-GAAP adjustments |
|
219.4 |
|
|
31.8 |
|
|
187.5 |
|
||||||||||
Non-GAAP | $ |
174.6 |
|
$ |
25.0 |
|
14.3 |
% |
$ |
149.5 |
|
$ |
0.80 |
|
Horizon Therapeutics plc |
||||||||||||||||||||||||
Certain Income Statement Line Items - Non-GAAP Adjusted |
||||||||||||||||||||||||
For the Three Months Ended June 30, 2020 and June 30, 2019 (Unaudited) |
||||||||||||||||||||||||
(in thousands) |
||||||||||||||||||||||||
Horizon Therapeutics plc | ||||||||||||||||||||||||
Certain Income Statement Line Items - Non-GAAP Adjusted | ||||||||||||||||||||||||
For the Three Months Ended June 30, 2020 | ||||||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||||||
Income Tax | ||||||||||||||||||||||||
Research & | Selling, General | Loss on Debt | Interest | Other | Benefit | |||||||||||||||||||
COGS | Development | & Administrative | Extinguishment | Expense | Expense | (Expense) | ||||||||||||||||||
GAAP as reported | $ |
(121,515 |
) |
$ |
(81,068 |
) |
$ |
(222,332 |
) |
$ |
(17,254 |
) |
$ |
(18,571 |
) |
$ |
632 |
|
$ |
(82,964 |
) |
|||
Non-GAAP Adjustments (in thousands): | ||||||||||||||||||||||||
Acquisition/divestiture-related costs(1) |
|
- |
|
|
47,328 |
|
|
(340 |
) |
|
- |
|
|
- |
|
|
115 |
|
|
- |
|
|||
Amortization and step-up: | ||||||||||||||||||||||||
Intangible amortization expense(2) |
|
66,547 |
|
|
- |
|
|
202 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|||
Amortization of debt discount and deferred financing costs(3) |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
5,248 |
|
|
- |
|
|
- |
|
|||
Impairment of long lived assets(4) |
|
- |
|
|
- |
|
|
1,072 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|||
Share-based compensation(5) |
|
1,288 |
|
|
2,552 |
|
|
23,217 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|||
Depreciation(6) |
|
90 |
|
|
18 |
|
|
6,799 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|||
Upfront, progress and milestone payments related to license and collaboration agreements(7) |
|
- |
|
|
3,000 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|||
Loss on debt extinguishment(8) |
|
- |
|
|
- |
|
|
- |
|
|
17,254 |
|
|
- |
|
|
- |
|
|
- |
|
|||
Income tax effect on pre-tax non-GAAP adjustments(9) |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(25,797 |
) |
|||
Other non-GAAP income tax adjustments(10) |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
15,210 |
|
|||
Total of non-GAAP adjustments |
|
67,925 |
|
|
52,898 |
|
|
30,950 |
|
|
17,254 |
|
|
5,248 |
|
|
115 |
|
|
(10,587 |
) |
|||
Non-GAAP | $ |
(53,590 |
) |
$ |
(28,170 |
) |
$ |
(191,382 |
) |
$ |
- |
|
$ |
(13,323 |
) |
$ |
747 |
|
$ |
(93,551 |
) |
|||
Horizon Therapeutics plc | ||||||||||||||||||||||||
Certain Income Statement Line Items - Non-GAAP Adjusted | ||||||||||||||||||||||||
For the Three Months Ended June 30, 2019 | ||||||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||||||
Income Tax | ||||||||||||||||||||||||
Research & | Selling, General | Loss/(Gain) on | Loss on Debt | Interest | Other | Benefit | ||||||||||||||||||
COGS | Development | & Administrative | Sale of Assets | Extinguishment | Expense | Income, net | (Expense) | |||||||||||||||||
GAAP as reported | $ |
(89,163 |
) |
$ |
(28,314 |
) |
$ |
(167,095 |
) |
$ |
(10,963 |
) |
$ |
(11,878 |
) |
$ |
(22,033 |
) |
$ |
(1,272 |
) |
$ |
4,875 |
|
Non-GAAP Adjustments (in thousands): | ||||||||||||||||||||||||
Acquisition/divestiture-related costs(1) |
|
- |
|
|
- |
|
|
73 |
|
|
- |
|
|
- |
|
|
- |
|
|
1,127 |
|
|
- |
|
Restructuring and realignment costs(11) |
|
- |
|
|
- |
|
|
13 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Amortization and step-up: | ||||||||||||||||||||||||
Intangible amortization expense(2) |
|
57,481 |
|
|
- |
|
|
202 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Inventory step-up expense |
|
(25 |
) |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Amortization of debt discount and deferred financing costs(3) |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
5,710 |
|
|
- |
|
|
- |
|
Loss on sale of assets(12) |
|
- |
|
|
- |
|
|
- |
|
|
10,963 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Share-based compensation(5) |
|
951 |
|
|
2,343 |
|
|
18,073 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Depreciation(6) |
|
158 |
|
|
- |
|
|
1,285 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Litigation settlements(13) |
|
- |
|
|
- |
|
|
1,000 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Upfront, progress and milestone payments related to license and collaboration agreements(7) |
|
- |
|
|
4,000 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Loss on debt extinguishment(8) |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
11,878 |
|
|
- |
|
|
- |
|
|
- |
|
Fees related to refinancing activities (14) |
|
- |
|
|
- |
|
|
1,033 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Drug substance harmonization costs(15) |
|
234 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Charges relating to discontinuation of Friedreich's ataxia program(16) |
|
1,300 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Income tax effect on pre-tax non-GAAP adjustments(9) |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(15,621 |
) |
Other non-GAAP income tax adjustments(10) |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(1,452 |
) |
Total of non-GAAP adjustments |
|
60,099 |
|
|
6,343 |
|
|
21,679 |
|
|
10,963 |
|
|
11,878 |
|
|
5,710 |
|
|
1,127 |
|
|
(17,073 |
) |
Non-GAAP | $ |
(29,064 |
) |
$ |
(21,971 |
) |
$ |
(145,416 |
) |
$ |
- |
|
$ |
- |
|
$ |
(16,323 |
) |
$ |
(145 |
) |
$ |
(12,198 |
) |
|
- |
|
Horizon Therapeutics plc |
||||||||||||||||||||||||
Certain Income Statement Line Items - Non-GAAP Adjusted |
||||||||||||||||||||||||
For the Six Months Ended June 30, 2020 and June 30, 2019 (Unaudited) |
||||||||||||||||||||||||
(in thousands) |
||||||||||||||||||||||||
Horizon Therapeutics plc | ||||||||||||||||||||||||
Certain Income Statement Line Items - Non-GAAP Adjusted | ||||||||||||||||||||||||
For the Six Months Ended June 30, 2020 | ||||||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||||||
Income Tax | ||||||||||||||||||||||||
Research & | Selling, General | Interest | Other | Loss on Debt | Benefit | |||||||||||||||||||
COGS | Development | & Administrative | Expense | Expense | Extinguishment | (Expense) | ||||||||||||||||||
GAAP as reported | $ |
(218,931 |
) |
$ |
(108,277 |
) |
$ |
(470,107 |
) |
$ |
(35,915 |
) |
$ |
1,074 |
|
$ |
(17,254 |
) |
$ |
(63,938 |
) |
|||
Non-GAAP Adjustments (in thousands): | ||||||||||||||||||||||||
Acquisition/divestiture-related costs(1) |
|
- |
|
|
47,328 |
|
|
(56 |
) |
|
- |
|
|
(175 |
) |
|
- |
|
|
- |
|
|||
Amortization and step-up: | ||||||||||||||||||||||||
Intangible amortization expense(2) |
|
124,921 |
|
|
- |
|
|
403 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|||
Amortization of debt discount and deferred financing costs(3) |
|
- |
|
|
- |
|
|
- |
|
|
10,817 |
|
|
- |
|
|
- |
|
|
- |
|
|||
Impairment of long lived assets(4) |
|
- |
|
|
- |
|
|
1,072 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|||
Share-based compensation(5) |
|
3,977 |
|
|
8,928 |
|
|
70,573 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|||
Depreciation(6) |
|
418 |
|
|
43 |
|
|
13,611 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|||
Upfront, progress and milestone payments related to license and collaboration agreements(7) |
|
- |
|
|
3,000 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|||
Fees related to refinancing activities (14) |
|
- |
|
|
- |
|
|
54 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|||
Loss on debt extinguishment(8) |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
17,254 |
|
|
- |
|
|||
Drug substance harmonization costs(15) |
|
290 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|||
Income tax effect on pre-tax non-GAAP adjustments(9) |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(57,059 |
) |
|||
Other non-GAAP income tax adjustments(10) |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
15,210 |
|
|||
Total of non-GAAP adjustments |
|
129,606 |
|
|
59,299 |
|
|
85,657 |
|
|
10,817 |
|
|
(175 |
) |
|
17,254 |
|
|
(41,849 |
) |
|||
Non-GAAP | $ |
(89,325 |
) |
$ |
(48,978 |
) |
$ |
(384,450 |
) |
$ |
(25,098 |
) |
$ |
899 |
|
$ |
- |
|
$ |
(105,787 |
) |
|||
Horizon Therapeutics plc | ||||||||||||||||||||||||
Certain Income Statement Line Items - Non-GAAP Adjusted | ||||||||||||||||||||||||
For the Six Months Ended June 30, 2019 | ||||||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||||||
Income Tax | ||||||||||||||||||||||||
Research & | Selling, General | Loss on Debt | Loss/(Gain) on | Interest | Other | Benefit | ||||||||||||||||||
COGS | Development | & Administrative | Extinguishment | Sale of Assets | Expense | Income | (Expense) | |||||||||||||||||
GAAP as reported | $ |
(177,305 |
) |
$ |
(50,039 |
) |
$ |
(339,394 |
) |
$ |
(17,464 |
) |
$ |
(10,963 |
) |
$ |
(49,563 |
) |
|
(1,083 |
) |
$ |
6,795 |
|
Non-GAAP Adjustments (in thousands): | ||||||||||||||||||||||||
Acquisition/divestiture-related costs(1) |
|
1,114 |
|
|
- |
|
|
164 |
|
|
- |
|
|
- |
|
|
- |
|
|
1,268 |
|
|
- |
|
Restructuring and realignment costs(11) |
|
- |
|
|
- |
|
|
33 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Amortization and step-up: | ||||||||||||||||||||||||
Intangible amortization expense(2) |
|
114,699 |
|
|
- |
|
|
401 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Inventory step-up expense |
|
90 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Amortization of debt discount and deferred financing costs(3) |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
11,622 |
|
|
- |
|
|
- |
|
Impairment of long lived assets(4) |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Loss on sale of assets(12) |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
10,963 |
|
|
- |
|
|
- |
|
|
- |
|
Share-based compensation(5) |
|
1,990 |
|
|
4,979 |
|
|
41,946 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Depreciation(6) |
|
317 |
|
|
- |
|
|
2,599 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Litigation settlements(13) |
|
- |
|
|
- |
|
|
1,000 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Upfront, progress and milestone payments related to license and collaboration agreements(7) |
|
- |
|
|
6,000 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Fees related to refinancing activities(14) |
|
- |
|
|
- |
|
|
1,175 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Loss on debt extinguishment(8) |
|
- |
|
|
- |
|
|
- |
|
|
17,464 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Drug substance harmonization costs(15) |
|
314 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Charges relating to discontinuation of Friedreich's ataxia program(16) |
|
1,221 |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Income tax effect on pre-tax non-GAAP adjustments(9) |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(30,372 |
) |
Other non-GAAP income tax adjustments(10) |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(1,452 |
) |
Total of non-GAAP adjustments |
|
119,745 |
|
|
10,979 |
|
|
47,318 |
|
|
17,464 |
|
|
10,963 |
|
|
11,622 |
|
|
1,268 |
|
|
(31,824 |
) |
Non-GAAP | $ |
(57,560 |
) |
$ |
(39,060 |
) |
$ |
(292,076 |
) |
$ |
- |
|
$ |
- |
|
$ |
(37,941 |
) |
$ |
185 |
|
$ |
(25,029 |
) |
NOTES FOR CERTAIN INCOME STATEMENT LINE ITEMS - NON-GAAP
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