Alkermes Plc Reports Financial Results for the Year Ended Dec. 31, 2018 and Provides Financial Expectations for 2019
DUBLIN, Feb. 14, 2019 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today reported financial results for the year ended Dec. 31, 2018 and provided financial expectations for 2019.
"Our strong financial results in 2018 were driven by the growth of our proprietary commercial products and the continued strength and diversity of our royalty and manufacturing business," commented James Frates, Chief Financial Officer of Alkermes. "As we enter 2019, our financial expectations reflect the continued growth of our proprietary products, VIVITROL(®) and ARISTADA(®), as well as important investments in the future growth drivers of the company including our advancing development pipeline and commercial capabilities to support our expanding presence in schizophrenia."
Quarter Ended Dec. 31, 2018 Financial Highlights
-- Total revenues for the quarter were $315.8 million. This compared to
$275.4 million for the same period in the prior year, representing an
increase of 15%. Proprietary product net sales for VIVITROL and
ARISTADA(i) were $132.7 million for the quarter, reflecting a 28%
increase compared to the same period in the prior year.
-- Net loss according to generally accepted accounting principles in the
U.S. (GAAP) was $9.7 million for the quarter, or a basic and diluted
GAAP net loss per share of $0.06. This compared to GAAP net loss of $9.8
million, or a basic and diluted GAAP net loss per share of $0.06, for
the same period in the prior year.
-- Non-GAAP net income was $54.8 million for the quarter, or a non-GAAP
basic earnings per share of $0.35 and non-GAAP diluted earnings per
share of $0.34. This compared to non-GAAP net income of $50.3 million,
or a non-GAAP basic earnings per share of $0.33 and non-GAAP diluted
earnings per share of $0.31, for the same period in the prior year.
"The launch of ARISTADA INITIO(®ii )continues to gain traction as payers and providers recognize the value proposition of this important new offering, particularly in combination with the ARISTADA two-month dose which provides the unique ability to fully dose a patient on day one for up to two months(iii). With this offering, we are supporting continuity of care which is critically important for this patient population. We also continue to build the customized commercial capabilities necessary to navigate this complex treatment environment, including recent expansions of our field- and hospital-based teams," stated Jim Robinson, President and Chief Operating Officer of Alkermes. "VIVITROL results for 2018 were in-line with our expectations and we are encouraged by solid growth trends across many states. As we enter 2019, we remain committed to increasing access to VIVITROL and driving increased adoption in order to meet the needs of patients with opioid and alcohol dependence."
Quarter Ended Dec. 31, 2018 Financial Results
Revenues
-- Net sales of VIVITROL were $83.8 million, compared to $75.6 million for
the same period in the prior year, representing an increase of
approximately 11%.
-- Net sales of ARISTADA were $48.8 million, compared to $28.3 million for
the same period in the prior year, representing an increase of
approximately 72%.
-- Manufacturing and royalty revenues from RISPERDAL CONSTA(®), INVEGA
SUSTENNA(®)/XEPLION(®) and INVEGA TRINZA(®)/TREVICTA(®) were $81.4
million, compared to $78.2 million for the same period in the prior
year.
-- Manufacturing and royalty revenues from AMPYRA/FAMPYRA(®iv) were $38.8
million, compared to $38.1 million for the same period in the prior
year, which was above our expectations given generic entry into the
market in 2018.
-- Manufacturing and royalty revenues included $26.7 million from Alkermes'
share of proceeds from the sale of certain royalty streams by Zealand
Pharma A/S, related to products using Alkermes' technology, to Royalty
Pharma.
-- Research and development revenues were $15.6 million, of which $14.4
million related to R&D reimbursement from the company's collaboration
with Biogen for diroximel fumarate, or BIIB098.
Costs and Expenses
-- Operating expenses were $315.7 million, compared to $269.5 million for
the same period in the prior year, primarily reflecting increased
investment in the commercialization of ARISTADA and VIVITROL.
Calendar Year 2018 Financial Highlights
-- Total revenues increased 21% to $1.09 billion in 2018, which included
VIVITROL net sales of $302.6 million and ARISTADA net sales of $147.7
million. This compared to total revenues of $903.4 million for 2017,
which included VIVITROL net sales of $269.3 million and ARISTADA net
sales of $93.5 million. Please see the tables at the end of this press
release for a detailed breakdown of the revenues from our key commercial
products.
-- GAAP net loss was $139.3 million, or a basic and diluted GAAP loss per
share of $0.90, for 2018. This compared to a GAAP net loss of $157.9
million, or a basic and diluted GAAP loss per share of $1.03, for 2017.
-- Non-GAAP net income was $97.8 million, or a non-GAAP basic earnings per
share of $0.63 and non-GAAP diluted earnings per share of $0.61, for
2018. This compared to non-GAAP net income of $27.8 million, or a
non-GAAP basic earnings per share of $0.18 and non-GAAP diluted earnings
per share of $0.17, for 2017.
-- At Dec. 31, 2018, Alkermes recorded cash, cash equivalents and total
investments of $620.0 million, compared to $590.7 million at Dec. 31,
2017. At Dec. 31, 2018, the company's total debt outstanding was $279.3
million, compared to $281.4 million at Dec. 31, 2017.
"Alkermes is defined by our commitment to making medicines that help address critical public health challenges, using our scientific insights to develop medicines that are designed with the real-world needs of patients in mind. Following the positive results of the ALKS 3831 ENLIGHTEN-2 pivotal study and the increasing traction of ARISTADA in the market, we continue to establish our emerging leadership position in the treatment of schizophrenia," said Richard Pops, Chief Executive Officer of Alkermes. "2019 will be an important year for our late-stage pipeline highlighted by the planned submission of the ALKS 3831 New Drug Application and the regulatory review of the recently submitted New Drug Application for diroximel fumarate for multiple sclerosis, with expected action in the fourth quarter. As development activities surrounding our ALKS 4230 immuno-oncology program gain momentum, we expect to have our first indications of ALKS 4230's anti-tumor response activity this year, and we look forward to updating you on our progress."
Recent Events:
-- ALKS 3831
-- In November 2018, Alkermes announced positive topline results from
ENLIGHTEN-2, a pivotal phase 3 study of ALKS 3831 compared to
olanzapine in patients with stable schizophrenia. In the study, ALKS
3831 met the pre-specified co-primary endpoints, demonstrating both
a lower mean percent weight gain from baseline at six months
compared to the olanzapine group and a lower proportion of patients
who gained 10% or more of their baseline body weight at six months
compared to the olanzapine group.
-- Diroximel fumarate (BIIB098)
-- In December 2018, Alkermes and Biogen announced the submission of a
New Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) for diroximel fumarate, a novel oral fumarate in development
for the treatment of relapsing forms of multiple sclerosis. If
approved, Biogen intends to market diroximel fumarate under the
brand name VUMERITY((TM)). This name has been conditionally accepted
by the FDA and will be confirmed upon approval.
-- ALKS 4230
-- In November 2018, Alkermes presented initial clinical data from the
ongoing dose-escalation stage of the phase 1 study for ALKS 4230 at
the 2018 Society for Immunotherapy of Cancer (SITC) Annual Meeting.
-- ALKS 5461
-- In January 2019, Alkermes received a Complete Response Letter from
the FDA regarding the NDA for ALKS 5461 for the adjunctive treatment
of major depressive disorder.
Upcoming Milestones:
The following outlines the company's expected upcoming milestones.
-- ARISTADA
-- Topline results from six-month phase 3b study evaluating ARISTADA
INITIO plus the ARISTADA two-month dose alongside INVEGA SUSTENNA in
patients experiencing an acute exacerbation of schizophrenia in H1
2019.
-- ALKS 3831
-- Presentation of data at medical meetings on the results from
ENLIGHTEN-2, a six-month weight study of ALKS 3831 compared to
olanzapine in patients with stable schizophrenia.
-- Planned submission of an NDA for ALKS 3831 for the treatment of
schizophrenia in mid-2019.
-- Diroximel fumarate
-- NDA acceptance and assignment of Prescription Drug User Fee Act
(PDUFA) target action date.
-- Topline results for EVOLVE-MS-2 head-to-head study of diroximel
fumarate compared to TECFIDERA(®) in mid-2019.
-- ALKS 4230
-- Initiation of subcutaneous dosing phase 1 study in Q1 2019.
-- Presentation of data at medical meetings from ongoing phase 1 study,
including monotherapy dose escalation and clinical evaluation of
ALKS 4230 in combination with PD-1 inhibitor pembrolizumab.
-- Completion of monotherapy dose-escalation stage and initiation of
monotherapy dose-expansion stage of phase 1 study.
Financial Expectations for 2019
The following outlines the company's financial expectations for 2019, which include planned investments in the company's pipeline of development candidates and commercial infrastructure to support the company's expanding presence in schizophrenia.
-- Revenues: The company expects total revenues to range from $1.14 billion
to $1.19 billion, driven by expected growth of our proprietary products
and an expected $150 million milestone payment from Biogen in the fourth
quarter related to the potential FDA approval of diroximel fumarate.
Included in this total revenue expectation, Alkermes expects VIVITROL
net sales to range from $330 million to $350 million, and ARISTADA net
sales to range from $210 million to $230 million.
-- Cost of Goods Manufactured and Sold: The company expects cost of goods
manufactured and sold to range from $180 million to $190 million.
-- Research and Development (R&D) Expenses: The company expects R&D
expenses to range from $450 million to $480 million.
-- Selling, General and Administrative (SG&A) Expenses: The company expects
SG&A expenses to range from $590 million to $620 million.
-- Amortization of Intangible Assets: The company expects amortization of
intangibles to be approximately $40 million.
-- Net Interest Expense: The company expects net interest expense to range
from $5 million to $10 million.
-- Income Tax Expense: The company expects income tax expense to range from
$10 million to $15 million.
-- GAAP Net Loss: The company expects GAAP net loss to range from $135
million to $165 million, or a basic and diluted loss per share of $0.87
to $1.06, based on a weighted average basic and diluted share count of
approximately 156 million shares outstanding.
-- Non-GAAP Net Income: The company expects non-GAAP net income to range
from $40 million to $70 million, or a non-GAAP basic earnings per share
of $0.26 to $0.45, based on a weighted average basic share count of
approximately 156 million shares outstanding and a non-GAAP diluted
earnings per share of $0.25 to $0.43, based on a weighted average
diluted share count of approximately 161 million shares outstanding.
-- Share-Based Compensation: The company expects share-based compensation
of approximately $120 million.
-- Capital Expenditures: The company expects capital expenditures to range
from $90 million to $100 million.
Conference Call
Alkermes will host a conference call and webcast presentation with accompanying slides at 8:30 a.m. ET (1:30 p.m. BST) on Thursday, Feb. 14, 2019, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes' website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Thursday, Feb. 14, 2019, through Thursday, Feb. 21, 2019, and may be accessed by visiting Alkermes' website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay conference ID is 13687392.
About Alkermes plc
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction, multiple sclerosis and oncology. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.
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 U.S. (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 future financial and operating performance, business plans or prospects; expectations concerning continued revenue growth from the company's commercial products, including the growth of VIVITROL, ARISTADA and ARISTADA INITIO and the company's expanding presence in the field of treatment of schizophrenia; expectations concerning the company's continued investment in its commercial capabilities and the value that can be derived therefrom; the potential therapeutic and commercial value of the company's marketed and development products, and patient access to and adoption of such products; expectations concerning the timing and results of clinical development and regulatory activities, including the anticipated presentation of data from the ENLIGHTEN-2 phase 3 clinical trial for ALKS 3831, the planned submission of an NDA for ALKS 3831, topline results from the EVOLVE-MS-2 head-to-head study of diroximel fumarate (BIIB098) compared to TECFIDERA, the FDA's anticipated acceptance of, and action with respect to, the NDA for diroximel fumarate, topline results from the phase 3b clinical trial evaluating ARISTADA INITIO plus ARISTADA two-month dose alongside INVEGA SUSTENNA, the progress of, and presentation of initial data from, the ALKS 4230 phase 1 study, and the initiation of a subcutaneous dosing phase 1 study for ALKS 4230. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so-called "Paragraph IV" litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real-world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading "Risk Factors" in the company's most recent Annual Report on Form 10-K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission ("SEC"), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.
VIVITROL(®) is a registered trademark of Alkermes, Inc.; ARISTADA(®) and ARISTADA INITIO(®) are registered trademarks of Alkermes Pharma Ireland Limited; RISPERDAL CONSTA(®), INVEGA SUSTENNA(®), XEPLION(®), INVEGA TRINZA(® )and TREVICTA(®) are registered trademarks of Johnson & Johnson; TECFIDERA(® )is a registered trademark of Biogen Inc.; and AMPYRA(®) and FAMPYRA(®) are registered trademarks of Acorda Therapeutics, Inc. ("Acorda")
(i) The term "ARISTADA" as used in this press release refers to ARISTADA and ARISTADA INITIO, unless the context indicates otherwise.
(ii) ARISTADA INITIO was approved by the FDA for the initiation of ARISTADA, a long-acting injectable atypical antipsychotic for the treatment of schizophrenia in adults. ARISTADA INITIO is to be administered with a single 30 mg dose of oral aripiprazole.
(iii) ARISTADA INITIO + single 30 mg oral dose of aripiprazole replaces need for concomitant three weeks of oral aripiprazole for initiation of ARISTADA, with relevant levels of aripiprazole concentration reached within four days.
(iv) AMPYRA(®) (dalfampridine) Extended Release Tablets, 10 mg is developed and marketed in the U.S. by Acorda and outside the U.S. by Biogen Inc., under a licensing agreement with Acorda, as FAMPYRA(®) (prolonged-release fampridine tablets).
(tables follow)
Alkermes plc and Subsidiaries
Selected Financial Information (Unaudited)
Three Months Ended
Three Months Ended
Condensed Consolidated Statements of Operations - GAAP
December 31,
December 31,
(In thousands, except per share data) 2018 2017
Revenues:
Manufacturing and royalty revenues $167,422 $138,700
Product sales, net 132,650 103,941
Research and development revenue 15,570 4,729
License revenues 120 28,000
Total Revenues 315,762 275,370
Expenses:
Cost of goods manufactured and sold 49,117 38,507
Research and development 108,972 104,490
Selling, general and administrative 141,227 110,896
Amortization of acquired intangible assets 16,426 15,642
Total Expenses 315,742 269,535
Operating Income 20 5,835
Other (Expense) Income, net:
Interest income 3,292 1,362
Interest expense (3,478) (3,192)
Change in the fair value of contingent consideration (2,300) 5,700
Other expense, net 775 1,081
Total Other (Expense) Income, net (1,711) 4,951
(Loss) Income Before Income Taxes (1,691) 10,786
Provision for income taxes 8,022 20,575
Net Loss - GAAP $(9,713) $(9,789)
Net (Loss) Earnings Per Share:
GAAP net loss per share - basic and diluted $(0.06) $(0.06)
Non-GAAP earnings per share - basic $0.35 $0.33
Non-GAAP earnings per share - diluted $0.34 $0.31
Weighted Average Number of Ordinary Shares Outstanding:
Basic and diluted - GAAP 155,506 153,865
Basic - Non-GAAP 155,506 153,865
Diluted - Non-GAAP 159,518 160,036
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income is as follows:
Net Loss - GAAP $(9,713) $(9,789)
Adjustments:
Share-based compensation expense 29,314 20,581
Amortization expense 16,426 15,642
Depreciation expense 9,476 9,575
Fixed asset impairment 5,746
Change in the fair value of contingent consideration 2,300 (5,700)
Income tax effect related to reconciling items 1,533 (1,726)
Non-cash net interest expense 169 192
Change in the fair value of warrants and equity method investments (410) 64
Income tax charge related to 2017 income tax reform (1) 21,453
Non-GAAP Net Income $54,841 $50,292
Year Ended
Year Ended
Condensed Consolidated Statements of Operations - GAAP
December 31,
December 31,
(In thousands, except per share data) 2018 2017
Revenues:
Manufacturing and royalty revenues $526,675 $505,308
Product sales, net 450,334 362,834
Research and development revenues 68,895 7,232
License revenues 48,370 28,000
Total Revenues 1,094,274 903,374
Expenses:
Cost of goods manufactured and sold 176,420 154,748
Research and development 425,406 412,889
Selling, general and administrative 526,408 421,578
Amortization of acquired intangible assets 65,168 62,059
Total Expenses 1,193,402 1,051,274
Operating Loss (99,128) (147,900)
Other (Expense) Income, net:
Interest income 9,238 4,649
Interest expense (15,437) (12,008)
Change in the fair value of contingent consideration (19,600) 21,600
Other expense, net (2,040) (9,615)
Total Other (Expense) Income, net (27,839) 4,626
Loss Before Income Taxes (126,967) (143,274)
Provision for income taxes 12,344 14,671
Net Loss - GAAP $(139,311) $(157,945)
Net (Loss) Earnings Per Share:
GAAP net loss per share - basic and diluted $(0.90) $(1.03)
Non-GAAP earnings per share - basic $0.63 $0.18
Non-GAAP earnings per share - diluted $0.61 $0.17
Weighted Average Number of Ordinary Shares Outstanding:
Basic and diluted - GAAP 155,112 153,415
Basic - Non-GAAP 155,112 153,415
Diluted - Non-GAAP 160,363 160,062
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income is as follows:
Net Loss - GAAP $(139,311) $(157,945)
Adjustments:
Share-based compensation expense 105,357 83,917
Amortization expense 65,168 62,059
Depreciation expense 38,492 36,464
Change in the fair value of contingent consideration 19,600 (21,600)
Fixed asset impairment 5,746
Restructuring expense 3,598
Debt refinancing charge 2,298
Non-cash net interest expense 700 770
Change in the fair value of warrants and equity method investments 190 2,824
Income tax effect related to reconciling items (4,002) (10,622)
Income tax charge related to 2017 income tax reform (1) 21,453
Other-than-temporary impairment of equity method investment 10,471
Non-GAAP Net Income $97,836 $27,791
Condensed Consolidated Balance Sheets
December 31,
December 31,
(In thousands) 2018 2017
---
Cash, cash equivalents and total investments $620,039 $590,716
Receivables 292,223 233,590
Contract assets 8,230
Inventory 90,196 93,275
Prepaid expenses and other current assets 53,308 48,475
Property, plant and equipment, net 309,987 284,736
Intangible assets, net and goodwill 283,874 349,041
Other assets 167,150 197,394
Total Assets $1,825,007 $1,797,227
Long-term debt - current portion $2,843 $3,000
Other current liabilities 336,931 288,122
Long-term debt 276,465 278,436
Contract liabilities - long-term 9,525 5,657
Other long-term liabilities 27,958 19,204
Total shareholders' equity 1,171,285 1,202,808
Total Liabilities and Shareholders' Equity $1,825,007 $1,797,227
Ordinary shares outstanding (in thousands) 155,757 154,009
This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in Alkermes plc's Annual Report on Form 10-K for the year ended December 31, 2018, which the company
intends to file in February 2019.
Alkermes plc and Subsidiaries
Revenues for Calendar Year 2018 and 2017
Three Months
Three Months
Three Months
Three Months
Year
Ended
Ended
Ended
Ended
Ended
March 31,
June 30,
September 30,
December 31,
December 31,
(In thousands) 2018 2018 2018 2018 2018
Revenues:
PARTNERED LONG-ACTING $68,790 $85,181 $77,202 $81,372 $312,545
ANTIPSYCHOTICS (2)
VIVITROL 62,682 76,203 79,893 83,831 302,609
ARISTADA 29,160 33,604 36,142 48,819 147,725
AMPYRA/FAMPYRA 28,259 19,678 20,339 38,778 107,054
BYDUREON 9,749 13,510 11,944 10,572 45,775
---
Key Commercial Product Revenues 198,640 228,176 225,520 263,372 915,708
Legacy Product Revenues 7,803 9,872 6,926 36,700 61,301
License Revenue(3) 48,250 120 48,370
Research and Development Revenues 18,707 18,344 16,274 15,570 68,895
---
Total Revenues $225,150 $304,642 $248,720 $315,762 $1,094,274
===
Three Months
Three Months
Three Months
Three Months
Year
Ended
Ended
Ended
Ended
Ended
March 31,
June 30,
September 30,
December 31,
December 31,
(In thousands) 2017 2017 2017 2017 2017
Revenues:
PARTNERED LONG-ACTING $60,003 $82,169 $79,443 $78,238 $299,853
ANTIPSYCHOTICS (2)
VIVITROL 58,456 66,071 69,178 75,617 269,322
ARISTADA 18,000 22,685 24,503 28,324 93,512
AMPYRA/FAMPYRA 29,219 25,256 24,478 38,066 117,019
BYDUREON 12,266 11,635 10,095 11,700 45,696
---
Key Commercial Product Revenues 177,944 207,816 207,697 231,945 825,402
Legacy Product Revenues 13,191 10,192 8,661 10,696 42,740
License Revenue(4) 28,000 28,000
Research and Development Revenues 643 833 1,027 4,729 7,232
---
Total Revenues $191,778 $218,841 $217,385 $275,370 $903,374
===
Alkermes plc and Subsidiaries
2019 Guidance - GAAP to Non-GAAP Adjustments
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) Earnings Per Share
---
Projected Net Loss - GAAP $(150.0) 156 $(0.96)
Adjustments:
Share-based compensation expense 120.0
Amortization expense 40.0
Depreciation expense 40.0
Non-cash net interest expense 1.0
Income tax effect related to reconciling items 4.0
Projected Net Income - Non-GAAP $55.0 161 $0.34
Projected GAAP and non-GAAP measures reflect mid-points within ranges of estimated guidance.
(1) -On December 22, 2017, the Tax Cuts and Jobs Act of 2017 was signed into law and has resulted in significant changes to the U.S. corporate income tax system including a federal corporate rate reduction from 35% to 21%. The change in tax rate and tax law is accounted for in the period of enactment. Therefore, during the period ended
December 31, 2017, we recorded a $21.5 million tax expense related to our current estimate of the provisions of the Tax Cuts and Jobs Act of 2017.
(2) - Includes RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA.
(3) - Includes a milestone payment allocated to the license sold to Biogen in connection with the BIIB098 collaboration.
(4) - Includes the upfront payment allocated to the license sold to Biogen in connection with the BIIB098 collaboration.
Alkermes Contacts:
For Investors:
Sandy Coombs +1 781 609 6377
For Media:
Matthew Henson +1 781 609 6637
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