— Total Revenues of
— GAAP Net Income of
— Company Expects to Generate 30% EBITDA Margin in 2024 —
"We entered 2024 as a pure-play neuroscience company and are well positioned to deliver on our strategic priorities to drive growth of our proprietary commercial products, advance the clinical development of ALKS 2680 for the treatment of narcolepsy, and generate significant cash flow," said
Key Financial Highlights
Revenues |
|||||||||
(In millions) |
Three Months Ended |
Twelve Months Ended |
|||||||
2023 |
2022 |
2023 |
2022 |
||||||
Total Revenues |
$ |
377.5 |
$ |
304.7 |
$ |
1,663.4 |
$ |
1,111.8 |
|
Total Proprietary |
$ |
242.0 |
$ |
216.1 |
$ |
920.0 |
$ |
777.6 |
|
VIVITROL® |
$ |
102.4 |
$ |
102.0 |
$ |
400.4 |
$ |
379.5 |
|
ARISTADA®i |
$ |
83.4 |
$ |
79.2 |
$ |
327.7 |
$ |
302.1 |
|
LYBALVI® |
$ |
56.2 |
$ |
34.9 |
$ |
191.9 |
$ |
96.0 |
|
Profitability |
|||||||||
(In millions) |
Three Months Ended |
Twelve Months Ended |
|||||||
2023 |
2022 |
2023 |
2022 |
||||||
GAAP Net Income (Loss) |
$ |
112.8 |
$ |
(28.3) |
$ |
355.8 |
$ |
(158.3) |
|
GAAP Net Income (Loss) |
$ |
160.6 |
$ |
17.2 |
$ |
519.2 |
$ |
(33.2) |
|
Non-GAAP Net Income |
$ |
37.4 |
$ |
24.2 |
$ |
243.7 |
$ |
57.9 |
|
Non-GAAP Net Income From |
$ |
81.8 |
$ |
67.4 |
$ |
396.5 |
$ |
174.9 |
|
EBITDA |
$ |
32.3 |
$ |
(1.2) |
$ |
323.8 |
$ |
(84.0) |
|
EBITDA From Continuing |
$ |
72.8 |
$ |
34.6 |
$ |
486.3 |
$ |
50.6 |
Please refer to Note 2 below for details related to certain tax provisions recorded during the quarter ended
Revenue Highlights
LYBALVI
- Revenues for the fourth quarter and year ended
- Fourth quarter revenues and total prescriptions grew 61% and 65%, respectively, compared to the fourth quarter of 2022.
ARISTADAi
- Revenues for the fourth quarter and year ended
- Fourth quarter revenues and total prescriptions (on a months of therapy basis) grew 5% and 4%, respectively, compared to the fourth quarter of 2022.
VIVITROL
- Revenues for the fourth quarter and year ended
Manufacturing & Royalties
- Royalty revenues from INVEGA SUSTENNA®/XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI® for the fourth quarter and year ended Dec. 31, 2023 were
- VUMERITY® revenues for the fourth quarter and year ended Dec. 31, 2023 were
Key Operating Expenses
Please see Note 1 below for details regarding discontinued operations.
(In millions) |
Three Months Ended |
Twelve Months Ended |
||||||||
2023 |
2022 |
2023 |
2022 |
|||||||
R&D Expense – |
$ |
73.9 |
$ |
73.0 |
$ |
270.8 |
$ |
272.7 |
||
R&D Expense – |
$ |
21.5 |
$ |
31.6 |
$ |
116.2 |
$ |
121.1 |
||
SG&A Expense – |
$ |
169.8 |
$ |
152.9 |
$ |
689.8 |
$ |
590.8 |
||
SG&A Expense – |
$ |
19.4 |
$ |
4.7 |
$ |
48.6 |
$ |
15.0 |
Year-over-year increase in SG&A expense related to continuing operations was driven primarily by investment in the LYBALVI direct-to-consumer advertising campaign and certain one-time expenses related to the successful resolution of legal proceedings including the Janssen arbitration and VIVITROL patent litigation.
Balance Sheet
At
Share Repurchase Program
On
Financial Expectations for 2024
All line items are according to GAAP, except as otherwise noted.
In millions |
2024 |
|
Total Revenues a |
|
|
VIVITROL Net Sales |
|
|
ARISTADAi |
|
|
LYBALVI Net Sales |
|
|
Cost of Goods Sold |
|
|
R&D Expenses |
|
|
SG&A Expenses |
|
|
GAAP Net Income b |
|
|
Non-GAAP Net Income b |
|
|
EBITDA |
|
|
Effective Tax Rate |
~17% |
a Expected Total Revenues reflect expiration of the |
b Expected 2024 weighted average basic share count of approximately 169.0 million shares outstanding and a weighted average diluted share count of approximately 173.0 million shares outstanding. |
Recent Events
- In
- In
- In
- In
Notes and Explanations
1. The company determined that upon the separation of its oncology business, completed on
2. During the quarter ended
(i) an income tax expense related to a reduced foreign derived intangible income deduction following the publication of new guidance on the application of Section 174 of the
(ii) a one-time charge related to the transfer of certain intellectual property in connection with the separation of the company's oncology business.
The tax benefit related to the release of the valuation allowance was excluded from non-GAAP net income due to the one-time nature of the benefit.
3. Under the share repurchase program, the company may repurchase ordinary shares of the company from time to time in an aggregate amount of up to
Conference Call
Alkermes will host a conference call and webcast presentation with accompanying slides at
About
Non-GAAP Financial Measures
This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the
Non-GAAP net income adjusts for certain one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; change in the fair value of contingent consideration; certain other one-time or non-cash items; and the income tax effect of these reconciling items. EBITDA represents earnings before interest, tax, depreciation and amortization; earnings include share-based compensation expense.
The company's management and board of directors utilize these non-GAAP financial measures to evaluate the company's performance. The company provides these non-GAAP financial measures of the company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income and EBITDA are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income and EBITDA should not be considered measures of the company's liquidity.
A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release.
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company's expectations concerning its future financial and operating performance, business plans or prospects, including its ability to grow its proprietary commercial products, generate cash and sustain profitability; the company's expectations regarding advancement of its development pipeline, including plans and expected timelines for the ALKS 2680 clinical development program, including initiation of the phase 2 study; the company's expectations regarding its share repurchase program; and the company's expectations regarding the sale of its development and manufacturing facility in Athlone,
VIVITROL® is a registered trademark of
________________________________ |
i The term "ARISTADA" as used in this press release refers to ARISTADA and ARISTADA INITIO®, unless the context indicates otherwise. |
(tables follow)
|
||||
Condensed Consolidated Statements of Operations - GAAP |
Three Months Ended |
Three Months Ended |
||
(In thousands, except per share data) |
|
|
||
Revenues: |
||||
Product sales, net |
$ 241,972 |
$ 216,117 |
||
Manufacturing and royalty revenues |
135,500 |
88,546 |
||
Research and development revenue |
3 |
11 |
||
Total Revenues |
377,475 |
304,674 |
||
Expenses: |
||||
Cost of goods manufactured and sold |
70,126 |
53,954 |
||
Research and development |
73,933 |
73,011 |
||
Selling, general and administrative |
169,789 |
152,852 |
||
Amortization of acquired intangible assets |
8,996 |
9,165 |
||
Total Expenses |
322,844 |
288,982 |
||
Operating Income |
54,631 |
15,692 |
||
Other Income (Expense), net: |
||||
Interest income |
9,749 |
3,921 |
||
Interest expense |
(6,054) |
(4,769) |
||
Other expense, net |
(10) |
(258) |
||
Total Other Income (Expense), net |
3,685 |
(1,106) |
||
Income Before Income Taxes |
58,316 |
14,586 |
||
Income Tax Benefit |
(102,236) |
(2,589) |
||
Net Income From Continuing Operations |
160,552 |
17,175 |
||
Loss from Discontinued Operations — Net of Tax |
$ (47,773) |
$ (45,429) |
||
Net Income (Loss) — GAAP |
$ 112,779 |
$ (28,254) |
||
GAAP Earnings (Loss) Per Share - Basic: |
||||
From continuing operations |
$ 0.96 |
$ 0.10 |
||
From discontinued operations |
$ (0.29) |
$ (0.28) |
||
Earnings (loss) per share |
$ 0.68 |
$ (0.17) |
||
GAAP Earnings (Loss) Per Share - Diluted: |
||||
From continuing operations |
$ 0.94 |
$ 0.10 |
||
From discontinued operations |
$ (0.28) |
$ (0.27) |
||
Earnings (loss) per share |
$ 0.66 |
$ (0.17) |
||
Weighted Average Number of Ordinary Shares Outstanding: |
||||
Basic — GAAP and Non-GAAP |
166,898 |
164,336 |
||
Diluted — GAAP and Non-GAAP |
170,138 |
169,304 |
||
An itemized reconciliation between net income from continuing operations on a GAAP basis and EBITDA is as follows: |
||||
Net Income from Continuing Operations |
$ 160,552 |
$ 17,175 |
||
Adjustments: |
||||
Depreciation expense |
9,225 |
10,013 |
||
Amortization expense |
8,996 |
9,165 |
||
Interest income |
(9,749) |
(3,921) |
||
Interest expense |
6,054 |
4,769 |
||
Income tax (benefit) provision |
(102,236) |
(2,589) |
||
EBITDA from Continuing Operations |
72,842 |
34,612 |
||
EBITDA from Discontinued Operations |
(40,537) |
(35,777) |
||
EBITDA |
$ 32,305 |
$ (1,165) |
||
An itemized reconciliation between net income from continuing operations on a GAAP basis and non-GAAP net income is as follows: |
||||
Net Income from Continuing Operations |
$ 160,552 |
$ 17,175 |
||
Adjustments: |
||||
Share-based compensation expense |
22,776 |
24,692 |
||
Depreciation expense |
9,225 |
10,013 |
||
Amortization expense |
8,996 |
9,165 |
||
Separation expense |
19,084 |
1,355 |
||
Income tax effect related to reconciling items |
22,011 |
4,847 |
||
Deferred tax valuation release |
(160,953) |
— |
||
Non-cash net interest expense |
115 |
116 |
||
Non-GAAP Net Income from Continuing Operations |
81,806 |
67,363 |
||
Non-GAAP Net Loss from Discontinued Operations |
(44,383) |
(43,142) |
||
Non-GAAP Net Income |
$ 37,423 |
$ 24,221 |
||
Non-GAAP diluted earnings per share from continuing operations |
$ 0.48 |
$ 0.40 |
||
Non-GAAP diluted loss per share from discontinued operations |
$ (0.26) |
$ (0.25) |
||
Non-GAAP diluted earnings per share |
$ 0.22 |
$ 0.14 |
||
|
||||
Selected Financial Information (Unaudited) |
||||
Condensed Consolidated Statements of Operations - GAAP |
Year Ended |
Year Ended |
||
(In thousands, except per share data) |
|
|
||
Revenues: |
||||
Product sales, net |
$ 919,998 |
$ 777,552 |
||
Manufacturing and royalty revenues |
743,388 |
331,983 |
||
License revenue |
— |
2,000 |
||
Research and development revenue |
19 |
260 |
||
Total Revenues |
1,663,405 |
1,111,795 |
||
Expenses: |
||||
Cost of goods manufactured and sold |
253,037 |
218,068 |
||
Research and development |
270,806 |
272,702 |
||
Selling, general and administrative |
689,751 |
590,751 |
||
Amortization of acquired intangible assets |
35,689 |
36,363 |
||
Total Expenses |
1,249,283 |
1,117,884 |
||
Operating Income (Loss) |
414,122 |
(6,089) |
||
Other Income (Expense), net: |
||||
Interest income |
30,854 |
7,629 |
||
Interest expense |
(23,032) |
(13,040) |
||
Change in the fair value of contingent consideration |
— |
(21,750) |
||
Other (expense) income, net |
(425) |
2,122 |
||
Total Other Income (Expense), net |
7,397 |
(25,039) |
||
Income (Loss) Before Income Taxes |
421,519 |
(31,128) |
||
Income Tax (Benefit) Provision |
(97,638) |
2,024 |
||
Net Income (Loss) From Continuing Operations |
519,157 |
(33,152) |
||
Discontinued Operations — Net of Tax |
(163,400) |
(125,115) |
||
Net Income (Loss) — GAAP |
$ 355,757 |
$ (158,267) |
||
GAAP Earnings (Loss) Per Share - Basic: |
||||
From continuing operations |
$ 3.12 |
$ (0.20) |
||
From discontinued operations |
$ (0.98) |
$ (0.76) |
||
Earnings (loss) per share |
$ 2.14 |
$ (0.97) |
||
GAAP Earnings (Loss) Per Share - Diluted: |
||||
From continuing operations |
$ 3.06 |
$ (0.20) |
||
From discontinued operations |
$ (0.96) |
$ (0.76) |
||
Earnings (loss) per share |
$ 2.10 |
$ (0.97) |
||
Weighted Average Number of Ordinary Shares Outstanding: |
||||
Basic — GAAP and Non-GAAP |
166,223 |
163,742 |
||
Diluted — GAAP |
169,730 |
163,742 |
||
Diluted — Non-GAAP |
169,730 |
168,362 |
||
An itemized reconciliation between net income (loss) from continuing operations on a GAAP basis and EBITDA is as follows: |
||||
Net Income (Loss) from Continuing Operations |
$ 519,157 |
$ (33,152) |
||
Adjustments: |
||||
Depreciation expense |
36,921 |
39,959 |
||
Amortization expense |
35,689 |
36,363 |
||
Interest income |
(30,854) |
(7,629) |
||
Interest expense |
23,032 |
13,040 |
||
Income tax (benefit) provision |
(97,638) |
2,024 |
||
EBITDA from Continuing Operations |
486,307 |
50,605 |
||
EBITDA from Discontinued Operations |
(162,484) |
(134,637) |
||
EBITDA |
$ 323,823 |
$ (84,032) |
||
An itemized reconciliation between net income (loss) from continuing operations on a GAAP basis and non-GAAP net income is as follows: |
||||
Net Income (Loss) from Continuing Operations |
$ 519,157 |
$ (33,152) |
||
Adjustments: |
||||
Share-based compensation expense |
92,719 |
87,676 |
||
Depreciation expense |
36,921 |
39,959 |
||
Amortization expense |
35,689 |
36,363 |
||
Separation expense |
38,364 |
1,355 |
||
Income tax effect related to reconciling items |
25,343 |
2,254 |
||
Final award in the Janssen arbitration (2022 back royalties and interest) |
(197,092) |
— |
||
Deferred tax valuation release |
(160,953) |
— |
||
Restructuring |
5,938 |
— |
||
Non-cash net interest expense |
461 |
466 |
||
Reduction in the fair value of contingent consideration and other related assets |
— |
24,032 |
||
Legal settlement |
— |
15,905 |
||
Non-GAAP Net Income from Continuing Operations |
396,547 |
174,858 |
||
Non-GAAP Net Loss from Discontinued Operations |
(152,894) |
(116,999) |
||
Non-GAAP Net Income |
$ 243,653 |
$ 57,859 |
||
Non-GAAP diluted earnings per share from continuing operations |
$ 2.34 |
$ 1.04 |
||
Non-GAAP diluted loss per share from discontinued operations |
$ (0.90) |
$ (0.69) |
||
Non-GAAP diluted earnings per share |
$ 1.44 |
$ 0.34 |
|
||||
Selected Financial Information (Unaudited) |
||||
Condensed Consolidated Balance Sheets |
|
|
||
(In thousands) |
2023 |
2022 |
||
Cash, cash equivalents and total investments |
$ 813,378 |
$ 740,075 |
||
Receivables |
332,477 |
287,967 |
||
Inventory |
186,406 |
181,418 |
||
Contract assets |
706 |
8,929 |
||
Prepaid expenses and other current assets |
98,166 |
41,203 |
||
Property, plant and equipment, net |
226,943 |
222,919 |
||
Intangible assets, net and goodwill |
85,018 |
120,707 |
||
Assets held for sale |
94,260 |
93,871 |
||
Assets from discontinued operations |
— |
40,087 |
||
Other assets |
298,869 |
226,802 |
||
Total Assets |
$ 2,136,223 |
$ 1,963,978 |
||
Long-term debt — current portion |
$ 3,000 |
$ 3,000 |
||
Other current liabilities |
512,678 |
488,898 |
||
Long-term debt |
287,730 |
290,270 |
||
Liabilities from discontinued operations |
4,542 |
19,386 |
||
Other long-term liabilities |
125,587 |
118,671 |
||
Total shareholders' equity |
1,202,686 |
1,043,753 |
||
Total Liabilities and Shareholders' Equity |
$ 2,136,223 |
$ 1,959,436 |
||
Ordinary shares outstanding (in thousands) |
166,980 |
164,377 |
||
This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in |
|
||||||||||
Amounts included in Discontinued Operations |
||||||||||
Three Months |
Three Months |
Three Months |
Three Months |
Year |
||||||
Ended |
Ended |
Ended |
Ended |
Ended |
||||||
|
|
|
|
|
||||||
(In thousands) |
2023 |
2023 |
2023 |
2023 |
2023 |
|||||
Cost of goods manufactured and sold |
$ 11 |
$ 11 |
$ 11 |
$ 6 |
$ 39 |
|||||
Research and development |
29,867 |
32,563 |
32,262 |
21,485 |
116,177 |
|||||
Selling, general and administrative |
6,644 |
9,502 |
13,073 |
19,368 |
48,587 |
|||||
Income tax (benefit) provision |
(6,727) |
(40) |
(1,550) |
6,914 |
(1,403) |
|||||
Loss from discontinued operations, net of tax |
$ 29,795 |
$ 42,036 |
$ 43,796 |
$ 47,773 |
$ 163,400 |
|||||
Three Months |
Three Months |
Three Months |
Three Months |
Year |
||||||
Ended |
Ended |
Ended |
Ended |
Ended |
||||||
|
|
|
|
|
||||||
(In thousands) |
2022 |
2022 |
2022 |
2022 |
2022 |
|||||
Cost of goods manufactured and sold |
$ 10 |
$ 10 |
$ 10 |
$ 10 |
$ 40 |
|||||
Research and development |
29,161 |
27,475 |
32,929 |
31,575 |
121,140 |
|||||
Selling, general and administrative |
3,201 |
3,488 |
3,618 |
4,689 |
14,996 |
|||||
Income tax (benefit) provision |
(22,883) |
1,374 |
1,293 |
9,155 |
(11,061) |
|||||
Loss from discontinued operations, net of tax |
$ 9,489 |
$ 32,347 |
$ 37,850 |
$ 45,429 |
$ 125,115 |
|
||||||||||
Revenues for Calendar Year 2023 and 2022 |
||||||||||
Three Months |
Three Months |
Three Months |
Three Months |
Year |
||||||
Ended |
Ended |
Ended |
Ended |
Ended |
||||||
|
|
|
|
|
||||||
(In thousands) |
2023 |
2023 |
2023 |
2023 |
2023 |
|||||
Revenues: |
||||||||||
VIVITROL |
$ 96,659 |
$ 102,070 |
$ 99,305 |
$ 102,385 |
$ 400,419 |
|||||
ARISTADA |
80,077 |
82,410 |
81,834 |
83,369 |
327,690 |
|||||
LYBALVI |
37,991 |
46,997 |
50,683 |
56,218 |
191,889 |
|||||
Total Proprietary Sales |
214,727 |
231,477 |
231,822 |
241,972 |
919,998 |
|||||
PARTNERED LONG-ACTING ANTIPSYCHOTICS (1) |
24,543 |
326,380 |
90,993 |
81,461 |
523,377 |
|||||
VUMERITY |
28,874 |
32,295 |
34,561 |
33,596 |
129,326 |
|||||
Key Commercial Product Revenues |
268,144 |
590,152 |
357,376 |
357,029 |
1,572,701 |
|||||
Legacy Product Revenues |
19,445 |
27,238 |
23,559 |
20,443 |
90,685 |
|||||
Research and Development Revenues |
6 |
7 |
3 |
3 |
19 |
|||||
Total Revenues |
$ 287,595 |
$ 617,397 |
$ 380,938 |
$ 377,475 |
$ 1,663,405 |
|||||
Three Months |
Three Months |
Three Months |
Three Months |
Year |
||||||
Ended |
Ended |
Ended |
Ended |
Ended |
||||||
|
|
|
|
|
||||||
(In thousands) |
2022 |
2022 |
2022 |
2022 |
2022 |
|||||
Revenues: |
||||||||||
VIVITROL |
$ 84,854 |
$ 96,105 |
$ 96,534 |
$ 101,985 |
$ 379,478 |
|||||
ARISTADA |
72,485 |
74,622 |
75,719 |
79,226 |
302,052 |
|||||
LYBALVI |
13,929 |
20,060 |
27,127 |
34,906 |
96,022 |
|||||
Total Proprietary Sales |
171,268 |
190,787 |
199,380 |
216,117 |
777,552 |
|||||
PARTNERED LONG-ACTING ANTIPSYCHOTICS (1) |
54,480 |
37,039 |
36,965 |
37,085 |
165,569 |
|||||
VUMERITY |
30,595 |
26,170 |
26,250 |
32,481 |
115,496 |
|||||
Key Commercial Product Revenues |
256,343 |
253,996 |
262,595 |
285,683 |
1,058,617 |
|||||
Legacy Product Revenues |
20,095 |
22,117 |
(10,274) |
18,980 |
50,918 |
|||||
License Revenue |
2,000 |
` |
— |
— |
— |
2,000 |
||||
Research and Development Revenues |
107 |
106 |
36 |
11 |
260 |
|||||
Total Revenues |
$ 278,545 |
$ 276,219 |
$ 252,357 |
$ 304,674 |
$ 1,111,795 |
(1) - Includes RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI. |
|
||
2024 Guidance — GAAP to EBITDA |
||
An itemized reconciliation between projected net income on a GAAP basis and EBITDA is as |
||
(In millions, except per share data) |
Amount |
|
Projected Net Income — GAAP |
$ 370.0 |
|
Adjustments: |
||
Net interest income |
(16.0) |
|
Depreciation expense |
35.0 |
|
Amortization expense |
1.0 |
|
Provision for income taxes |
75.0 |
|
Projected EBITDA |
$ 465.0 |
|
Projected Net Income on a GAAP basis and Projected EBITDA reflect mid-points within ranges |
|
||||||
2024 Guidance — GAAP to Non-GAAP Adjustments |
||||||
An itemized reconciliation between projected earnings per share on a GAAP basis and projected earnings per share on a non- |
||||||
(In millions, except per share data) |
Amount |
Shares |
Earnings Per |
|||
Projected Net Income — GAAP |
$ 370.0 |
173.0 |
$ 2.14 |
|||
Adjustments: |
||||||
Share-based compensation expense |
86.0 |
|||||
Depreciation expense |
35.0 |
|||||
Amortization expense |
1.0 |
|||||
Non-cash net interest expense |
0.5 |
|||||
Income tax effect related to reconciling items |
(7.5) |
|||||
Projected Net Income — Non-GAAP |
$ 485.0 |
173.0 |
$ 2.80 |
|||
Projected GAAP and non-GAAP measures reflect mid-points within ranges of estimated guidance. |
Alkermes Contacts:
For Investors:
For Media: Katie Joyce +1 781 249 8927
View original content to download multimedia:https://www.prnewswire.com/news-releases/alkermes-plc-reports-financial-results-for-the-fourth-quarter-and-year-ended-dec-31-2023-and-provides-financial-expectations-for-2024-302062983.html
SOURCE