Significant Accounting Policies (Tables)
|
9 Months Ended |
Sep. 30, 2026 |
|---|
| Significant Accounting Policies [Line Items] |
|
| Summary of Impact of Accounts Receivable Reserves on Gross Trade Accounts Receivable Balances |
The following table summarizes the impact of accounts receivable reserves on the gross trade accounts receivable balances as of September 30, 2026 and December 31, 2025:
|
|
|
|
|
|
|
|
|
In thousands |
|
September 30, 2026 |
|
|
December 31, 2025 |
|
Gross trade accounts receivable |
|
$ |
127,529 |
|
|
$ |
144,983 |
|
Trade allowances |
|
|
(15,520 |
) |
|
|
(17,189 |
) |
Chargebacks |
|
|
(436 |
) |
|
|
(962 |
) |
Accounts receivable, net |
|
$ |
111,573 |
|
|
$ |
126,832 |
|
|
| Calculation of Net Income (Loss) and Number of Ordinary Shares and ADSs Used to Compute Basic and Diluted Net Earnings (Loss) per Ordinary Share and ADS |
The calculation of net income (loss) and the number of Ordinary Shares and ADSs used to compute basic and diluted net earnings (loss) per Ordinary Share and ADS for the three and nine months ended September 30, 2026 and 2025 are as follows:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
|
For the Nine Months Ended September 30, |
|
In thousands |
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
Net income (loss)—basic and diluted |
|
$ |
245 |
|
|
$ |
(7,738 |
) |
|
$ |
(17,917 |
) |
|
$ |
(37,574 |
) |
Weighted average Ordinary Shares outstanding—basic |
|
|
417,766 |
|
|
|
415,531 |
|
|
|
420,178 |
|
|
|
414,607 |
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
Restricted stock units |
|
|
7,203 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Stock options |
|
|
2,887 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Weighted average shares outstanding—diluted |
|
|
427,856 |
|
|
|
415,531 |
|
|
|
420,178 |
|
|
|
414,607 |
|
Earnings (loss) per Ordinary Share—basic |
|
$ |
0.00 |
|
|
$ |
(0.02 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.09 |
) |
Earnings (loss) per Ordinary Share— diluted |
|
$ |
0.00 |
|
|
$ |
(0.02 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.09 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average ADS outstanding—basic |
|
|
20,888 |
|
|
|
20,776 |
|
|
|
21,008 |
|
|
|
20,730 |
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
Restricted stock units |
|
|
360 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Stock options |
|
|
144 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Weighted average ADS outstanding—diluted |
|
|
21,392 |
|
|
|
20,776 |
|
|
|
21,008 |
|
|
|
20,730 |
|
Earnings (loss) per ADS—basic |
|
$ |
0.01 |
|
|
$ |
(0.37 |
) |
|
$ |
(0.85 |
) |
|
$ |
(1.81 |
) |
Earnings (loss) per ADS— diluted |
|
$ |
0.01 |
|
|
$ |
(0.37 |
) |
|
$ |
(0.85 |
) |
|
$ |
(1.81 |
) |
|
| Anti-Dilutive Securities Not Included in the Computation of Net Earnings (Loss) per Share |
For the three and nine months ended September 30, 2026 and 2025, the following potentially dilutive securities were not included in the computation of net earnings (loss) per share because the effect would be anti-dilutive or because performance criteria were not yet met for awards contingent upon such measures:
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
|
For the Nine Months Ended September 30, |
|
In thousands |
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
Stock options |
|
|
26,104 |
|
|
|
30,769 |
|
|
|
28,991 |
|
|
|
30,769 |
|
Restricted stock and restricted stock units |
|
|
132 |
|
|
|
14,726 |
|
|
|
7,335 |
|
|
|
14,726 |
|
|
| Estimated Fair Value of Assets and Liability |
The following tables present information about the estimated fair value of the Company’s assets and liabilities as of September 30, 2026 and December 31, 2025, and indicate the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2026 |
|
In thousands |
|
Total |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
Asset: |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury Securities |
|
$ |
178,486 |
|
|
$ |
178,486 |
|
|
$ |
— |
|
|
$ |
— |
|
Money Market Fund |
|
|
40,404 |
|
|
|
40,404 |
|
|
|
— |
|
|
|
— |
|
Repo Securities |
|
|
5,000 |
|
|
|
— |
|
|
|
5,000 |
|
|
|
— |
|
Total |
|
$ |
223,890 |
|
|
$ |
218,890 |
|
|
$ |
5,000 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2025 |
|
In thousands |
|
Total |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
Asset: |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury Securities |
|
$ |
168,095 |
|
|
$ |
168,095 |
|
|
$ |
— |
|
|
$ |
— |
|
Money Market Fund |
|
|
45,377 |
|
|
|
45,377 |
|
|
|
— |
|
|
|
— |
|
Repo Securities |
|
|
5,000 |
|
|
|
— |
|
|
|
5,000 |
|
|
|
— |
|
Total |
|
$ |
218,472 |
|
|
$ |
213,472 |
|
|
$ |
5,000 |
|
|
$ |
— |
|
|
| Summary of Restructuring Charges |
The following table sets forth the components of the Company's restructuring charges for the three and nine months ended September 30, 2026 and 2025:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
|
For the Nine Months Ended September 30, |
|
In thousands |
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
Employee restructuring separation charges |
|
$ |
— |
|
|
$ |
10,714 |
|
|
$ |
3,094 |
|
|
$ |
23,428 |
|
Vendor contract charges |
|
|
— |
|
|
|
(1,308 |
) |
|
|
269 |
|
|
|
8,737 |
|
Total restructuring expense |
|
|
— |
|
|
|
9,406 |
|
|
|
3,363 |
|
|
|
32,165 |
|
Stock acceleration |
|
|
— |
|
|
|
399 |
|
|
|
(35 |
) |
|
|
(2,176 |
) |
Total restructuring costs incurred |
|
$ |
— |
|
|
$ |
9,805 |
|
|
$ |
3,328 |
|
|
$ |
29,989 |
|
|
| Change in Restructuring Liability |
The following table shows the change in restructuring liability, which is included within accrued expenses and other current liabilities:
|
|
|
|
|
In thousands |
|
Restructuring Liability |
|
Balance at December 31, 2025 |
|
$ |
7,427 |
|
Restructuring cash obligations incurred |
|
|
3,328 |
|
Payments |
|
|
(9,833 |
) |
Balance at September 30, 2026 |
|
$ |
922 |
|
|
| Single Reportable Segment [Member] |
|
| Significant Accounting Policies [Line Items] |
|
| Summary of Reportable Segment Profit or Loss Including Significant Reportable Segment Expenses |
The table below is a summary of the reportable segment profit or loss, including significant reportable segment expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
|
For the Nine Months Ended September 30, |
|
In thousands |
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
US product revenue, net |
$ |
28,525 |
|
|
$ |
40,866 |
|
|
$ |
96,386 |
|
|
$ |
113,028 |
|
Europe product revenue, net |
|
3,713 |
|
|
|
4,095 |
|
|
|
14,072 |
|
|
|
16,060 |
|
RoW product revenue, net |
|
4,652 |
|
|
|
3,597 |
|
|
|
8,835 |
|
|
|
7,122 |
|
Total product revenue, net |
|
36,890 |
|
|
|
48,558 |
|
|
|
119,293 |
|
|
|
136,210 |
|
Licensing and royalty revenue |
|
2,660 |
|
|
|
1,112 |
|
|
|
7,600 |
|
|
|
28,217 |
|
Total revenue, net |
|
39,550 |
|
|
|
49,670 |
|
|
|
126,893 |
|
|
|
164,427 |
|
Less: Cost of goods sold |
|
23,369 |
|
|
|
27,462 |
|
|
|
77,954 |
|
|
|
66,728 |
|
Gross margin |
|
16,181 |
|
|
|
22,208 |
|
|
|
48,939 |
|
|
|
97,699 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Selling |
|
1,882 |
|
|
|
2,722 |
|
|
|
6,223 |
|
|
|
18,582 |
|
General and administrative (1) |
|
7,264 |
|
|
|
9,012 |
|
|
|
32,525 |
|
|
|
32,185 |
|
Research and development |
|
1,535 |
|
|
|
1,289 |
|
|
|
4,708 |
|
|
|
5,216 |
|
Payroll and payroll related expense |
|
6,484 |
|
|
|
8,528 |
|
|
|
22,051 |
|
|
|
43,250 |
|
Non-cash stock-based compensation expense |
|
1,376 |
|
|
|
2,354 |
|
|
|
5,773 |
|
|
|
10,146 |
|
Restructuring |
|
— |
|
|
|
9,406 |
|
|
|
3,363 |
|
|
|
32,165 |
|
Total operating expenses |
|
18,541 |
|
|
|
33,311 |
|
|
|
74,643 |
|
|
|
141,544 |
|
Operating loss |
|
(2,360 |
) |
|
|
(11,103 |
) |
|
|
(25,704 |
) |
|
|
(43,845 |
) |
Interest income, net |
|
2,371 |
|
|
|
2,783 |
|
|
|
7,845 |
|
|
|
8,277 |
|
Other income, net |
|
304 |
|
|
|
205 |
|
|
|
1,583 |
|
|
|
372 |
|
Income (loss) from operations before taxes |
|
315 |
|
|
|
(8,115 |
) |
|
|
(16,276 |
) |
|
|
(35,196 |
) |
(Provision for) benefit from income taxes |
|
(70 |
) |
|
|
377 |
|
|
|
(1,641 |
) |
|
|
(2,378 |
) |
Segment & consolidated net income (loss) |
$ |
245 |
|
|
$ |
(7,738 |
) |
|
$ |
(17,917 |
) |
|
$ |
(37,574 |
) |
(1) During the nine months ended September 30, 2026 the Company recorded litigation-related charges of $9.4 million within general and administrative expense.
|