Alkermes plc Reports Financial Results for the Year Ended Dec. 31, 2016 and Provides Financial Expectations
for 2017
— Record Revenues of $746 Million, GAAP Loss Per Share of $1.38 and Non-GAAP Loss Per Share of $0.07
Reported for 2016 —
— VIVITROL® Net Sales Grew by 45% Year-Over-Year to $209.0 Million —
— 2017 Total Revenues Expected to Grow by Approximately 20%, Driven by Continuing Volume Growth of VIVITROL
and ARISTADA® —
— Company Plans to Submit New Drug Application for ALKS 5461 in 2017 —
Alkermes plc (NASDAQ: ALKS) today reported financial results for the twelve months ended Dec. 31, 2016 and
provided financial expectations for 2017.
“Our 2016 financial results reflect the strong growth of our proprietary commercial products and demonstrate the power and
breadth of the Alkermes business,” commented James Frates, Chief Financial Officer of Alkermes. “We enter 2017 in a strong
financial position and expect total revenues to grow approximately 20%, driven by the robust volume growth of VIVITROL® and ARISTADA®. In 2017, we are making additional investments that will drive the future growth
of Alkermes, including in our development pipeline, the commercial organization for ALKS 5461 and expanded VIVITROL manufacturing
capabilities to support expected demand into the 2020s.”
“We have built Alkermes to thrive in an increasingly challenging biopharmaceutical industry. Our base business of FDA-approved
medicines is significant and growing, led by VIVITROL and ARISTADA. We have identified our next phase of growth based on a
remarkable, late-stage, phase 3 portfolio. Our focus on large, chronic diseases of the CNS coupled with our approach to selecting,
developing, and commercializing medicines is unique and built for a complex public health environment,” said Richard Pops, Chief
Executive Officer of Alkermes. “2017 will bring an unprecedented level of activity across all of the major areas of Alkermes. Our
proprietary commercial products, VIVITROL and ARISTADA, will continue their growth as we bring new and distinctive features to
patients and providers. For ARISTADA, we expect approval and launch of the two-month dose mid-year, which will be the only
two-month option available in the long-acting injectable antipsychotic market. Our late-stage pipeline will continue to evolve
rapidly, highlighted by the planned NDA submission for ALKS 5461 in major depressive disorder, the completion of the pivotal
efficacy study of ALKS 3831 in schizophrenia, and completion of the required elements for registration of ALKS 8700 in multiple
sclerosis.”
Quarter Ended Dec. 31, 2016 Financial Highlights
- Total revenues for the quarter were $213.5 million. This compared to $163.1 million for the same
period in the prior year, representing an increase of 31%.
- Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $21.1 million,
or a basic and diluted GAAP loss per share of $0.14. This compared to GAAP net loss of $69.4 million, or a basic and diluted GAAP
loss per share of $0.46 for the same period in the prior year.
- Non-GAAP net income was $23.3 million, or a non-GAAP basic and diluted earnings per share of $0.15
for the quarter. This compared to non-GAAP net loss of $21.0 million, or a non-GAAP basic and diluted loss per share of $0.14 for
the same period in the prior year.
Quarter Ended Dec. 31, 2016 Financial Results
Revenues
- Net sales of VIVITROL were $62.1 million, compared to $38.2 million for the same period in the prior
year, representing an increase of 62%. On a unit basis, sales grew 67% compared to the same period in the prior year.
- Net sales of ARISTADA were $17.3 million, up from $4.6 million in the fourth quarter of 2015, which
was the quarter of launch.
- Manufacturing and royalty revenues from RISPERDAL CONSTA®, INVEGA
SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA® were $74.0 million, compared to $75.1
million for the same period in the prior year.
- Manufacturing and royalty revenues from AMPYRA®/FAMPYRA®1 were $32.3 million,
representing a 69% increase compared to $19.1 million for the same period in the prior year.
- Royalty revenue from BYDUREON® was $11.3 million, compared to $12.2 million for the same
period in the prior year.
Costs and Expenses
- Operating expenses were $237.1 million for the quarter ended Dec. 31, 2016, compared to $230.2
million for the same period in the prior year.
Calendar Year 2016 Financial Highlights
- Total revenues increased 19% to $745.7 million in 2016, which included VIVITROL net sales of $209.0
million and ARISTADA net sales of $47.2 million. This compared to total revenues of $628.3 million for 2015. 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 $208.4 million, or a basic and diluted GAAP loss per share of $1.38, for 2016. This
compared to a GAAP net loss of $227.2 million, or a basic and diluted GAAP loss per share of $1.52, for 2015.
- Non-GAAP net loss was $10.3 million, or a non-GAAP basic and diluted loss per share of $0.07, for
2016. This compared to non-GAAP net loss of $56.8 million, or a non-GAAP basic and diluted loss per share of $0.38, for
2015.
- At Dec. 31, 2016, Alkermes recorded cash and total investments of $619.2 million, compared to $798.8
million at Dec. 31, 2015. At Dec. 31, 2016, the company’s total debt outstanding was $283.7 million, compared to $349.9 million
at Dec. 31, 2015.
Financial Expectations for 2017
The following outlines the company’s financial expectations for 2017, which include investments in commercial infrastructure in
preparation for the expected launch of ALKS 5461 in 2018 and in Alkermes’ pipeline of late-stage development candidates. The
following statements are forward-looking, and actual results may differ materially. Please see “Note Regarding Forward-Looking
Statements” at the end of this press release for risks that could cause results to differ materially from these forward-looking
statements.
- Revenues: The company expects total revenues to range from $870 million to $920 million, a 17%
to 23% increase from 2016, driven by continuing growth of VIVITROL and ARISTADA. Included in this total revenue expectation,
Alkermes expects VIVITROL net sales to range from $280 million to $300 million.
- Cost of Goods Manufactured and Sold: The company expects cost of goods manufactured and sold
to range from $150 million to $160 million.
- Research and Development (R&D) Expenses: The company expects R&D expenses to range
from $405 million to $435 million.
- Selling, General and Administrative (SG&A) Expenses: The company expects SG&A expenses
to range from $425 million to $455 million.
- Amortization of Intangible Assets: The company expects amortization of intangibles to be
approximately $60 million.
- Net Interest Expense: The company expects net interest expense to be approximately $10
million.
- Income Tax Expense: The company expects income tax expense of up to $10 million.
- GAAP Net Loss: The company expects GAAP net loss to range from $180 million to $210 million,
or a basic and diluted loss per share of $1.17 to $1.36, based on a weighted average basic and diluted share count of
approximately 154 million shares outstanding.
- Non-GAAP Net Income (Loss): The company expects its non-GAAP financial measure to be in the
range of non-GAAP net loss of $15 million to non-GAAP net income of $15 million. This equates to a non-GAAP basic loss per share
of $0.10 to a non-GAAP basic income per share of $0.10, based on a weighted average basic share count of approximately 154
million shares outstanding, and a non-GAAP diluted loss per share of $0.10 to a non-GAAP diluted income per share of $0.09, based
on a weighted average diluted share count of approximately 161 million shares outstanding.
- Capital Expenditures: The company expects capital expenditures to range from $70 million to
$80 million.
Conference Call
Alkermes will host a conference call at 8:30 a.m. ET (1:30 p.m. GMT) on Wednesday, Feb. 15, 2017, to discuss these financial
results and provide an update on the company. The conference call may be accessed by visiting Alkermes’ website or by dialing +1
888 424 8151 for U.S. callers and +1 847 585 4422 for international callers. The conference call ID number is 6037988. In addition,
a replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. GMT) on Wednesday, Feb. 15, 2017, through 5:00 p.m.
ET (10:00 p.m. GMT) on Wednesday, Feb. 22, 2017, and may be accessed by visiting Alkermes’ website or by dialing +1 888 843 7419
for U.S. callers and +1 630 652 3042 for international callers. The replay access code is 6037988.
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 and multiple sclerosis.
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 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, better
indicate underlying trends in ongoing operations. However, non-GAAP net income (loss) and non-GAAP 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 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: future financial and
operating performance, business plans or prospects, including the launch of ALKS 5461; the likelihood of continued revenue growth
from the company’s commercial products, including the growth of VIVITROL and ARISTADA; the therapeutic and commercial value of the
company’s products; and expectations concerning the timing and results of clinical development activities, including the timing of
the NDA submission for ALKS 5461. 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; data
from clinical trials may be interpreted by the U.S. Food and Drug Administration (“FDA”) in different ways than we interpret it;
the FDA may not agree with our regulatory approval strategies or components of our filings, such as clinical trial designs;
clinical development activities may not be completed on time or at all; the results of such 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 partners, may not be able to continue to successfully commercialize its
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 any
other subsequent filings made by the company, with the Securities and Exchange Commission (“SEC”) and 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 they are made. The information contained in this press release is
provided by the company as of the date hereof, and, except as required by law, the company disclaims any intention or
responsibility for updating or revising any forward-looking information contained in this press release.
VIVITROL® is a registered trademark of Alkermes, Inc.; ARISTADA® is a registered trademark of Alkermes
Pharma Ireland Limited; RISPERDAL CONSTA®, INVEGA SUSTENNA®, XEPLION®, INVEGA TRINZA®
and TREVICTA® are registered trademarks of Johnson & Johnson; AMPYRA® and FAMPYRA® are
registered trademarks of Acorda Therapeutics, Inc.; BYDUREON® is a registered trademark of Amylin Pharmaceuticals,
LLC.
1AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg is developed and marketed in the U.S. by Acorda
Therapeutics, Inc. and outside the U.S. by Biogen Idec, under a licensing agreement with Acorda Therapeutics, as
FAMPYRA® (prolonged-release fampridine tablets).
(tables follow)
|
|
|
|
|
|
|
| Alkermes plc and Subsidiaries |
| Selected Financial Information (Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Three Months |
|
|
|
Ended |
|
|
Ended |
| Condensed Consolidated Statements of Operations - GAAP |
|
|
December 31, |
|
|
December 31, |
| (In thousands, except per share data) |
|
|
2016 |
|
|
2015 |
| Revenues: |
|
|
|
|
|
|
| Manufacturing and royalty revenues |
|
|
$ 133,804 |
|
|
|
$ 119,310 |
|
| Product sales, net |
|
|
79,451 |
|
|
|
42,816 |
|
| Research and development revenues |
|
|
259 |
|
|
|
972 |
|
| Total Revenues |
|
|
213,514 |
|
|
|
163,098 |
|
| Expenses: |
|
|
|
|
|
|
| Cost of goods manufactured and sold |
|
|
34,957 |
|
|
|
34,791 |
|
| Research and development |
|
|
89,627 |
|
|
|
93,686 |
|
| Selling, general and administrative |
|
|
97,145 |
|
|
|
87,472 |
|
| Amortization of acquired intangible assets |
|
|
15,322 |
|
|
|
14,206 |
|
| Total Expenses |
|
|
237,051 |
|
|
|
230,155 |
|
| Operating Loss |
|
|
(23,537 |
) |
|
|
(67,057 |
) |
| Other Expense, net: |
|
|
|
|
|
|
| Interest income |
|
|
835 |
|
|
|
1,010 |
|
| Interest expense |
|
|
(4,896 |
) |
|
|
(3,319 |
) |
| Loss on the Gainesville Transaction |
|
|
- |
|
|
|
(301 |
) |
| Change in the fair value of contingent consideration |
|
|
4,800 |
|
|
|
(5,000 |
) |
| Other (expense) income, net |
|
|
(1,515 |
) |
|
|
1,874 |
|
| Total Other Expense, net |
|
|
(776 |
) |
|
|
(5,736 |
) |
| Loss Before Income Taxes |
|
|
(24,313 |
) |
|
|
(72,793 |
) |
| Income Tax Benefit |
|
|
(3,172 |
) |
|
|
(3,411 |
) |
| Net Loss — GAAP |
|
|
$ (21,141 |
) |
|
|
$ (69,382 |
) |
|
|
|
|
|
|
|
| Net (Loss) Earnings Per Share: |
|
|
|
|
|
|
| GAAP net loss per share — basic and diluted |
|
|
$ (0.14 |
) |
|
|
$ (0.46 |
) |
| Non-GAAP net earnings (loss) per share — basic and diluted |
|
|
$ 0.15 |
|
|
|
$ (0.14 |
) |
|
|
|
|
|
|
|
| Weighted Average Number of Ordinary Shares Outstanding: |
|
|
|
|
|
|
| Basic and diluted — GAAP |
|
|
152,148 |
|
|
|
150,330 |
|
| Basic — Non-GAAP |
|
|
152,148 |
|
|
|
150,330 |
|
| Diluted — Non-GAAP |
|
|
159,212 |
|
|
|
150,330 |
|
|
|
|
|
|
|
|
| An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income
(loss) is as follows: |
|
|
| Net Loss — GAAP |
|
|
$ (21,141 |
) |
|
|
$ (69,382 |
) |
| Adjustments: |
|
|
|
|
|
|
| Share-based compensation expense |
|
|
19,783 |
|
|
|
22,869 |
|
| Amortization expense |
|
|
15,322 |
|
|
|
14,206 |
|
| Depreciation expense |
|
|
9,326 |
|
|
|
7,575 |
|
| Income tax effect related to reconciling items |
|
|
1,636 |
|
|
|
(618 |
) |
| Non-cash net interest expense |
|
|
194 |
|
|
|
233 |
|
| Loss on warrants and equity method investments |
|
|
866 |
|
|
|
463 |
|
| Loss on debt refinancing |
|
|
2,075 |
|
|
|
- |
|
| Change in the fair value of contingent consideration |
|
|
(4,800 |
) |
|
|
5,000 |
|
| Loss on the Gainesville Transaction |
|
|
- |
|
|
|
301 |
|
| Gain on sale of property, plant and equipment |
|
|
- |
|
|
|
(1,646 |
) |
| Non-GAAP Net Income (Loss) |
|
|
$ 23,261 |
|
|
|
$ (20,999 |
) |
|
|
|
|
|
|
|
|
|
Year Ended |
|
Year Ended |
| Condensed Consolidated Statements of Operations - GAAP |
|
|
December 31, |
|
December 31, |
| (In thousands, except per share data) |
|
|
2016 |
|
|
2015 |
| Revenues: |
|
|
|
|
|
|
| Manufacturing and royalty revenues |
|
|
$ 487,247 |
|
|
|
$ 475,288 |
|
| Product sales, net |
|
|
256,146 |
|
|
|
149,028 |
|
| Research and development revenues |
|
|
2,301 |
|
|
|
4,019 |
|
| Total Revenues |
|
|
745,694 |
|
|
|
628,335 |
|
| Expenses: |
|
|
|
|
|
|
| Cost of goods manufactured and sold |
|
|
132,122 |
|
|
|
138,989 |
|
| Research and development |
|
|
387,148 |
|
|
|
344,404 |
|
| Selling, general and administrative |
|
|
374,130 |
|
|
|
311,558 |
|
| Amortization of acquired intangible assets |
|
|
60,959 |
|
|
|
57,685 |
|
| Total Expenses |
|
|
954,359 |
|
|
|
852,636 |
|
| Operating Loss |
|
|
(208,665 |
) |
|
|
(224,301 |
) |
| Other (Expense) Income, net: |
|
|
|
|
|
|
| Interest income |
|
|
3,752 |
|
|
|
3,330 |
|
| Interest expense |
|
|
(14,889 |
) |
|
|
(13,247 |
) |
| Gain on the Gainesville Transaction |
|
|
- |
|
|
|
9,636 |
|
| Change in the fair value of contingent consideration |
|
|
7,900 |
|
|
|
(2,300 |
) |
| Other (expense) income, net |
|
|
(2,485 |
) |
|
|
2,877 |
|
| Total Other (Expense) Income, net |
|
|
(5,722 |
) |
|
|
296 |
|
| Loss Before Income Taxes |
|
|
(214,387 |
) |
|
|
(224,005 |
) |
| Income Tax (Benefit) Provision |
|
|
(5,943 |
) |
|
|
3,158 |
|
| Net Loss — GAAP |
|
|
$ (208,444 |
) |
|
|
$ (227,163 |
) |
|
|
|
|
|
|
|
| Net Loss Per Share: |
|
|
|
|
|
|
| GAAP net loss per share — basic and diluted |
|
|
$ (1.38 |
) |
|
|
$ (1.52 |
) |
| Non-GAAP net loss per share — basic and diluted |
|
|
$ (0.07 |
) |
|
|
$ (0.38 |
) |
|
|
|
|
|
|
|
| Weighted Average Number of Ordinary Shares Outstanding: |
|
|
|
|
|
|
| Basic and diluted — GAAP and Non-GAAP |
|
|
151,484 |
|
|
|
149,206 |
|
|
|
|
|
|
|
|
| An itemized reconciliation between net loss on a GAAP basis and non-GAAP net loss is
as follows: |
|
| Net Loss — GAAP |
|
|
$ (208,444 |
) |
|
|
$ (227,163 |
) |
| Adjustments: |
|
|
|
|
|
|
| Share-based compensation expense |
|
|
94,396 |
|
|
|
97,342 |
|
| Amortization expense |
|
|
60,958 |
|
|
|
57,685 |
|
| Depreciation expense |
|
|
33,298 |
|
|
|
27,911 |
|
| Income tax effect related to reconciling items |
|
|
2,252 |
|
|
|
(2,822 |
) |
| Loss (gain) on warrants and equity method investments |
|
|
2,130 |
|
|
|
(1,286 |
) |
| Non-cash net interest expense |
|
|
888 |
|
|
|
938 |
|
| Upfront license option payment to Reset Therapeutics, Inc. charged to R&D
expense |
|
10,000 |
|
|
|
- |
|
| Loss on debt refinancing |
|
|
2,075 |
|
|
|
|
| Change in the fair value of contingent consideration |
|
|
(7,900 |
) |
|
|
2,300 |
|
| Gain on the Gainesville Transaction |
|
|
- |
|
|
|
(9,636 |
) |
| Gain on sale of property, plant and equipment |
|
|
- |
|
|
|
(2,101 |
) |
| Non-GAAP Net Loss |
|
|
$ (10,347 |
) |
|
|
$ (56,832 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pursuant to compliance and disclosure interpretations published by the SEC in May 2016, the Company made certain changes to how
it presents non-GAAP net loss. The Company no longer adjusts the deferred revenue recognized in the period and now reflects the tax
effect of the reconciling items, as opposed to the non-cash taxes, as was previously the case. The Company revised its prior period
presentation to reflect its current period presentation.
|
|
|
|
|
|
|
| Condensed Consolidated Balance Sheets |
|
|
December 31, |
|
|
December 31, |
| (In thousands) |
|
|
2016 |
|
|
2015 |
| Cash, cash equivalents and total investments |
|
|
$ 619,164 |
|
|
$ 798,849 |
| Receivables |
|
|
191,102 |
|
|
155,487 |
| Inventory |
|
|
62,998 |
|
|
38,411 |
| Prepaid expenses and other current assets |
|
|
39,345 |
|
|
26,286 |
| Property, plant and equipment, net |
|
|
264,785 |
|
|
254,819 |
| Intangible assets, net and goodwill |
|
|
411,100 |
|
|
472,059 |
| Other assets |
|
|
137,929 |
|
|
109,833 |
| Total Assets |
|
|
$ 1,726,423 |
|
|
$ 1,855,744 |
| Long-term debt — current portion |
|
|
$ 3,000 |
|
|
$ 65,737 |
| Other current liabilities |
|
|
208,993 |
|
|
170,470 |
| Long-term debt |
|
|
280,666 |
|
|
284,207 |
| Deferred revenue — long-term |
|
|
7,122 |
|
|
7,975 |
| Other long-term liabilities |
|
|
17,161 |
|
|
13,080 |
| Total shareholders' equity |
|
|
1,209,481 |
|
|
1,314,275 |
| Total Liabilities and Shareholders' Equity |
|
|
$ 1,726,423 |
|
|
$ 1,855,744 |
|
|
|
|
|
|
|
| Ordinary shares outstanding (in thousands) |
|
|
152,431 |
|
|
150,701 |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
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, 2016, which the company intends to file in
February 2017.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Revenues for Calendar Year 2016 and 2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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) |
|
|
2016 |
|
|
2016 |
|
|
2016 |
|
|
2016 |
|
|
2016 |
| Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| PARTNERED LONG-ACTING ANTIPSYCHOTICS (1) |
|
|
$ 54,667 |
|
|
$ 69,578 |
|
|
$ 73,251 |
|
|
$ 73,967 |
|
|
$ 271,463 |
| AMPYRA/FAMPYRA |
|
|
28,194 |
|
|
40,848 |
|
|
12,897 |
|
|
32,254 |
|
|
114,193 |
| BYDUREON |
|
|
10,533 |
|
|
12,303 |
|
|
11,554 |
|
|
11,256 |
|
|
45,646 |
| VIVITROL |
|
|
43,827 |
|
|
47,242 |
|
|
55,804 |
|
|
62,109 |
|
|
208,982 |
| ARISTADA |
|
|
5,547 |
|
|
10,277 |
|
|
13,998 |
|
|
17,342 |
|
|
47,164 |
| Key Commercial Product Revenues |
|
|
142,768 |
|
|
180,248 |
|
|
167,504 |
|
|
196,928 |
|
|
687,448 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Legacy Product Revenues (2) |
|
|
12,765 |
|
|
14,305 |
|
|
12,548 |
|
|
16,327 |
|
|
55,945 |
| Research and Development Revenues |
|
|
1,241 |
|
|
612 |
|
|
189 |
|
|
259 |
|
|
2,301 |
| Total Revenues |
|
|
$ 156,774 |
|
|
$ 195,165 |
|
|
$ 180,241 |
|
|
$ 213,514 |
|
|
$ 745,694 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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) |
|
|
2015 |
|
|
2015 |
|
|
2015 |
|
|
2015 |
|
|
2015 |
| Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| PARTNERED LONG-ACTING ANTIPSYCHOTICS (1) |
|
|
$ 46,864 |
|
|
$ 60,841 |
|
|
$ 67,606 |
|
|
$ 75,074 |
|
|
$ 250,385 |
| AMPYRA/FAMPYRA |
|
|
36,549 |
|
|
26,939 |
|
|
22,132 |
|
|
19,116 |
|
|
104,736 |
| BYDUREON |
|
|
9,800 |
|
|
11,081 |
|
|
13,039 |
|
|
12,195 |
|
|
46,115 |
| VIVITROL |
|
|
31,137 |
|
|
37,172 |
|
|
37,903 |
|
|
38,227 |
|
|
144,439 |
| ARISTADA |
|
|
- |
|
|
- |
|
|
- |
|
|
4,589 |
|
|
4,589 |
| Key Commercial Product Revenues |
|
|
124,350 |
|
|
136,033 |
|
|
140,680 |
|
|
149,201 |
|
|
550,264 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Legacy Product Revenues (2) |
|
|
17,314 |
|
|
13,737 |
|
|
11,295 |
|
|
12,925 |
|
|
55,271 |
| Gainesville Revenues |
|
|
19,167 |
|
|
565 |
|
|
- |
|
|
- |
|
|
19,732 |
| Research and Development Revenues |
|
|
383 |
|
|
1,035 |
|
|
678 |
|
|
972 |
|
|
3,068 |
| Total Revenues |
|
|
$ 161,214 |
|
|
$ 151,370 |
|
|
$ 152,653 |
|
|
$ 163,098 |
|
|
$ 628,335 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Total Revenues excluding Gainesville Revenues |
|
|
$ 142,047 |
|
|
$ 150,805 |
|
|
$ 152,653 |
|
|
$ 163,098 |
|
|
$ 608,603 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) - Includes RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA.
(2) - Includes legacy product revenues, excluding product revenues sold as part of the Gainesville transaction.
| |
|
2017 Guidance — GAAP to Non-GAAP Adjustments
|
| |
|
An itemized reconciliation between projected loss per share on a GAAP basis and projected earnings
(loss) per share
|
| on a non-GAAP basis is as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss)/Earnings |
| (In millions, except per share data) |
|
|
Amount |
|
|
Shares |
|
|
Per Share |
| Projected Net Loss — GAAP |
|
|
$ (195.0 |
) |
|
|
154 |
|
|
$ (1.27 |
) |
| Adjustments: |
|
|
|
|
|
|
|
|
|
| Non-cash net interest expense |
|
|
1.0 |
|
|
|
|
|
|
|
| Income tax effect related to reconciling items |
|
|
1.5 |
|
|
|
|
|
|
|
| Depreciation expense |
|
|
37.5 |
|
|
|
|
|
|
|
| Amortization expense |
|
|
60.0 |
|
|
|
|
|
|
|
| Share-based compensation expense |
|
|
95.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Projected Non-GAAP Net Income (Loss) |
|
|
$ - |
|
|
|
161 |
|
|
$ - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Projected GAAP and non-GAAP measures reflect mid-points within ranges of estimated guidance.
Alkermes plc
For Investors:
Sandy Coombs, +1 781-609-6377
or
Eva Stroynowski, +1 781-609-6823
or
For Media:
Jennifer Snyder, +1 781-609-6166
View source version on businesswire.com: http://www.businesswire.com/news/home/20170215005205/en/