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"2020 was a demonstration of the resiliency of our organization, as we adapted our business to endure a pandemic that has proved to be one of the most disruptive events in our recent history. Despite the challenges posed by COVID-19, we achieved significant growth of net sales from our portfolio of proprietary commercial products, advanced our pipeline of neuroscience and oncology candidates, and announced a Value Enhancement Plan designed to drive growth and improve operational and financial performance," said
Quarter Ended
Year Ended
Revenues
Costs and Expenses
Net Loss/Net Income
Balance Sheet
"Our solid 2020 financial results demonstrate efficient management of our business from a financial and operational perspective in response to the significant disruptions caused by the pandemic. These efforts underscore our focus on execution and reflect our commitment to driving bottom line growth," commented
Financial Expectations for 2021
The following financial expectations for 2021 are based on recent trends and assume continuation of such trends into the first half of the year, and an anticipated improvement in patient access to treatment providers and to the company's commercial products in the second half of the year. If patient access does not improve as anticipated, or if new COVID-19-related disruptions emerge, the company's ability to meet these expectations could be negatively impacted. All line items are according to GAAP, except as otherwise noted.
In millions (except per share amounts) |
2021 Expectation (Provided 2/11/21) |
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Total Revenue |
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VIVITROL Net Sales |
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ARISTADA Net Sales |
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LYBALVI Net Sales |
< |
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Cost of Goods Sold |
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R&D Expenses |
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SG&A Expenses |
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Amortization of Intangible Assets |
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Income Tax Expense |
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GAAP Net Loss |
( |
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GAAP Net Loss per Share |
( |
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Non-GAAP Net Income |
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Non-GAAP Diluted EPS |
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Capital Expenditures |
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*R&D expense expectations for 2021 include a potential
Recent Events:
LYBALVI (formerly referred to as ALKS 3831)
Nemvaleukin alfa ("nemvaleukin", formerly referred to as ALKS 4230)
HDAC-inhibitor platform
Other
Corporate
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 GAAP, including non-GAAP net income (loss) and non-GAAP basic and diluted earnings (loss) per share. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies.
Non-GAAP net income (loss) adjusts for one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; certain other one-time or non-cash items; and the income tax effect of these reconciling items.
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 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 (loss) and non-GAAP basic and diluted earnings (loss) per share 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 (loss) and non-GAAP basic and diluted earnings (loss) per share should not be considered measures of our 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 future financial and operating performance, business plans or prospects, including the expected drivers of future value creation, expectations of revenue growth and diversification of the company's commercial portfolio and the anticipated improvement in patient access to healthcare providers and to the company's commercial products; the company's ability to execute on its strategic priorities and plans to manage for long-term profitability through execution of its Value Enhancement Plan, including through the achievement of multi-year profitability targets, review and optimization of its cost structure and potential monetization of non-core assets; the potential therapeutic and commercial value of the company's marketed and development products; the
VIVITROL® is a registered trademark of
(tables follow)
|
||||
Selected Financial Information (Unaudited) |
||||
Condensed Consolidated Statements of Operations - GAAP |
Three Months Ended |
Three Months Ended |
||
(In thousands, except per share data) |
|
|
||
Revenues: |
||||
Product sales, net |
$ 148,961 |
$ 149,609 |
||
Manufacturing and royalty revenues |
130,893 |
107,287 |
||
Research and development revenue |
141 |
11,084 |
||
License revenue |
— |
144,750 |
||
Total Revenues |
279,995 |
412,730 |
||
Expenses: |
||||
Cost of goods manufactured and sold |
42,922 |
46,482 |
||
Research and development |
112,107 |
198,157 |
||
Selling, general and administrative |
145,778 |
154,453 |
||
Amortization of acquired intangible assets |
9,917 |
10,171 |
||
Restructuring expense |
— |
13,401 |
||
Total Expenses |
310,724 |
422,664 |
||
Operating Loss |
(30,729) |
(9,934) |
||
Other (Expense) Income, net: |
||||
Interest income |
1,036 |
3,191 |
||
Interest expense |
(1,869) |
(3,196) |
||
Change in the fair value of contingent consideration |
(12,681) |
5,000 |
||
Other income, net |
2,597 |
2,382 |
||
Total Other (Expense) Income, net |
(10,917) |
7,377 |
||
Loss Before Income Taxes |
(41,646) |
(2,557) |
||
Provision for Income Taxes |
996 |
2,797 |
||
Net Loss — GAAP |
$ (42,642) |
$ (5,354) |
||
(Loss) Earnings Per Share: |
||||
GAAP loss per share — basic and diluted |
$ (0.27) |
$ (0.03) |
||
Non-GAAP earnings per share — basic and diluted |
$ 0.10 |
$ 0.83 |
||
Weighted Average Number of Ordinary Shares Outstanding: |
||||
Basic and diluted — GAAP |
159,153 |
157,662 |
||
Basic — Non-GAAP |
159,153 |
157,662 |
||
Diluted — Non-GAAP |
161,267 |
159,073 |
||
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income is as follows: |
||||
Net Loss — GAAP |
$ (42,642) |
$ (5,354) |
||
Adjustments: |
||||
Share-based compensation expense |
24,884 |
21,387 |
||
Depreciation expense |
10,411 |
10,340 |
||
Amortization expense |
9,917 |
10,171 |
||
Income tax effect related to reconciling items |
1,121 |
592 |
||
Non-cash net interest expense |
166 |
168 |
||
Change in the fair value of contingent consideration |
12,681 |
(5,000) |
||
Change in the fair value of warrants |
— |
(930) |
||
Acquisition of IPR&D |
— |
86,595 |
||
Restructuring expense |
— |
13,401 |
||
Non-GAAP Net Income |
$ 16,538 |
$ 131,370 |
||
Condensed Consolidated Statements of Operations - GAAP |
Year Ended |
Year Ended |
||
(In thousands, except per share data) |
|
|
||
Revenues: |
||||
Product sales, net |
$ 551,760 |
$ 524,499 |
||
Manufacturing and royalty revenues |
484,000 |
447,882 |
||
Research and development revenue |
1,946 |
52,816 |
||
License revenue |
1,050 |
145,750 |
||
Total Revenues |
1,038,756 |
1,170,947 |
||
Expenses: |
||||
Cost of goods manufactured and sold |
178,316 |
180,385 |
||
Research and development |
394,588 |
512,833 |
||
Selling, general and administrative |
538,827 |
599,449 |
||
Amortization of acquired intangible assets |
39,452 |
40,358 |
||
Restructuring expense |
— |
13,401 |
||
Total Expenses |
1,151,183 |
1,346,426 |
||
Operating Loss |
(112,427) |
(175,479) |
||
Other Income (Expense), net: |
||||
Interest income |
6,960 |
13,976 |
||
Interest expense |
(8,659) |
(13,601) |
||
Change in the fair value of contingent consideration |
3,945 |
(22,800) |
||
Other income, net |
13,644 |
848 |
||
Total Other Income (Expense), net |
15,890 |
(21,577) |
||
Loss Before Income Taxes |
(96,537) |
(197,056) |
||
Provision (Benefit) for Income Taxes |
14,324 |
(436) |
||
Net Loss — GAAP |
$ (110,861) |
$ (196,620) |
||
(Loss) Earnings Per Share: |
||||
GAAP loss per share — basic and diluted |
$ (0.70) |
$ (1.25) |
||
Non-GAAP earnings per share — basic and diluted |
$ 0.43 |
$ 0.71 |
||
Weighted Average Number of Ordinary Shares Outstanding: |
||||
Basic and diluted — GAAP |
158,803 |
157,051 |
||
Basic — Non-GAAP |
158,803 |
157,051 |
||
Diluted — Non-GAAP |
159,861 |
159,056 |
||
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income is as follows: |
||||
Net Loss — GAAP |
$ (110,861) |
$ (196,620) |
||
Adjustments: |
||||
Share-based compensation expense |
90,161 |
100,977 |
||
Depreciation expense |
42,402 |
40,055 |
||
Amortization expense |
39,452 |
40,358 |
||
Income tax effect related to reconciling items |
10,092 |
5,762 |
||
Non-cash net interest expense |
666 |
673 |
||
Change in the fair value of contingent consideration |
(3,945) |
22,800 |
||
Change in the fair value of warrants |
— |
(1,837) |
||
Acquisition of IPR&D |
674 |
86,595 |
||
Restructuring expense |
— |
13,401 |
||
Non-GAAP Net Income |
$ 68,641 |
$ 112,164 |
||
Condensed Consolidated Balance Sheets |
|
|
||
(In thousands) |
2020 |
2019 |
||
Cash, cash equivalents and total investments |
$ 659,807 |
$ 614,370 |
||
Receivables |
275,143 |
257,086 |
||
Contract assets |
14,401 |
8,386 |
||
Inventory |
125,738 |
101,803 |
||
Prepaid expenses and other current assets |
60,662 |
59,716 |
||
Property, plant and equipment, net |
350,003 |
362,168 |
||
Intangible assets, net and goodwill |
204,064 |
243,516 |
||
Other assets |
259,912 |
158,358 |
||
Total Assets |
$ 1,949,730 |
$ 1,805,403 |
||
Long-term debt — current portion |
$ 2,843 |
$ 2,843 |
||
Other current liabilities |
435,415 |
388,269 |
||
Long-term debt |
272,118 |
274,295 |
||
Contract liabilities — long-term |
16,397 |
22,068 |
||
Other long-term liabilities |
155,975 |
32,486 |
||
Total shareholders' equity |
1,066,982 |
1,085,442 |
||
Total Liabilities and Shareholders' Equity |
$ 1,949,730 |
$ 1,805,403 |
||
Ordinary shares outstanding (in thousands) |
159,161 |
157,779 |
||
This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in |
|
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Revenues for Calendar Year 2020 and 2019 |
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Three Months |
Three Months |
Three Months |
Three Months |
Year |
||||||
Ended |
Ended |
Ended |
Ended |
Ended |
||||||
|
|
|
|
|
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(In thousands) |
2020 |
2020 |
2020 |
2020 |
2020 |
|||||
Revenues: |
||||||||||
PARTNERED LONG-ACTING ANTIPSYCHOTICS (1) |
$ 82,243 |
$ 83,114 |
$ 87,876 |
$ 92,327 |
$ 345,560 |
|||||
VIVITROL |
78,769 |
71,646 |
80,258 |
80,049 |
310,722 |
|||||
ARISTADA |
50,957 |
58,769 |
62,400 |
68,912 |
241,038 |
|||||
Key Commercial Product Revenues |
211,969 |
213,529 |
230,534 |
241,288 |
897,320 |
|||||
Legacy Product Revenues |
34,008 |
33,391 |
32,475 |
38,566 |
138,440 |
|||||
License Revenue |
— |
` |
— |
1,050 |
— |
1,050 |
||||
Research and Development Revenues |
243 |
609 |
953 |
141 |
1,946 |
|||||
Total Revenues |
$ 246,220 |
$ 247,529 |
|
|
$ 1,038,756 |
|||||
Three Months |
Three Months |
Three Months |
Three Months |
Year |
||||||
Ended |
Ended |
Ended |
Ended |
Ended |
||||||
|
|
|
|
|
||||||
(In thousands) |
2019 |
2019 |
2019 |
2019 |
2019 |
|||||
Revenues: |
||||||||||
PARTNERED LONG-ACTING ANTIPSYCHOTICS (1) |
$ 75,605 |
$ 91,863 |
$ 76,716 |
$ 79,147 |
$ 323,331 |
|||||
VIVITROL |
69,183 |
88,199 |
85,164 |
92,818 |
335,364 |
|||||
ARISTADA |
30,298 |
48,436 |
53,610 |
56,791 |
189,135 |
|||||
Key Commercial Product Revenues |
175,086 |
228,498 |
215,490 |
228,756 |
847,830 |
|||||
Legacy Product Revenues |
33,310 |
36,034 |
27,067 |
28,140 |
124,551 |
|||||
License Revenue(2) |
— |
1,000 |
— |
144,750 |
145,750 |
|||||
Research and Development Revenues |
14,706 |
14,340 |
12,686 |
11,084 |
52,816 |
|||||
Total Revenues |
$ 223,102 |
$ 279,872 |
|
|
$ 1,170,947 |
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(1) - Includes RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA. |
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(2) - Includes a milestone payment received in the fourth quarter of 2019 which was allocated to the license sold to Biogen in connection with the VUMERITY collaboration. |
|
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2021 Guidance — GAAP to Non-GAAP Adjustments |
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An itemized reconciliation between projected loss per share on a GAAP basis and projected earnings per share on a non-GAAP basis is as follows: |
||||||
(In millions, except per share data) |
Amount |
Shares |
(Loss) |
|||
Projected Net Loss — GAAP |
$ (105.0) |
160 |
$ (0.66) |
|||
Adjustments: |
||||||
Share-based compensation expense |
93.0 |
|||||
Depreciation expense |
46.0 |
|||||
Amortization expense |
40.0 |
|||||
Income tax effect related to reconciling items |
5.0 |
|||||
Non-cash net interest expense |
1.0 |
|||||
Projected Net Income — Non-GAAP |
$ 80.0 |
161 |
$ 0.50 |
|||
Projected GAAP and non-GAAP measures reflect mid-points within ranges of estimated guidance. |
_________________________________________
i The term "ARISTADA" as used in this press release refers to ARISTADA and ARISTADA INITIO®, unless the context indicates otherwise.
ii CoREST: Co-repressor of repressor element-1 silencing transcription factor.
iii Trivedi MH, Walker R, Ling W, et al. Bupropion and Naltrexone in Methamphetamine Use Disorder.
Alkermes Contacts:
For Investors: Sandy Coombs +1 781 609 6377
For Media: Katie Joyce +1 781 249 8927
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