Alkermes plc Reports Second Quarter 2016 Financial Results
— Second Quarter Revenues Increase 29% Year-Over-Year to $195.2 Million; GAAP Loss per Share of $0.31 and
Non-GAAP Loss per Share of $0.01 —
— Company Improves Financial Expectations for 2016 Driven by Strong VIVITROL®
Performance —
— ARISTADA® Revenues Grow as Launch Progresses —
Alkermes plc (NASDAQ: ALKS) today reported financial results for the second quarter of 2016.
“Our second quarter results demonstrate the power of our business model to efficiently capture operating leverage as our topline
grows. These results reflect the growth of VIVITROL® and launch of ARISTADA® as well as the continued
strength of our royalty and manufacturing business. VIVITROL’s robust growth continued as we expand access and utilization in the
large Medicaid patient population. We are also encouraged by our progress with the launch of ARISTADA, for which our second quarter
results were slightly ahead of expectations,” commented James Frates, Chief Financial Officer of Alkermes. “Today we are improving
our financial expectations for 2016 to reflect the accelerating growth in VIVITROL net sales. With our highly diversified portfolio
and strong financial position, we have the resources to advance our innovative pipeline and invest in the ongoing launch of
ARISTADA and growth of VIVITROL.”
“Our proprietary commercial products, VIVITROL and ARISTADA, represent important growth opportunities at a time when substance
abuse and mental illness are significant public health priorities,” said Richard Pops, Chief Executive Officer of Alkermes.
“Against this backdrop, we continue to make important advances for VIVITROL and are just beginning to see what its ultimate
potential may be. The launch of ARISTADA in the rapidly growing, long-acting antipsychotic market continues to progress well, with
reimbursement and access initiatives advancing across the country. We are also making headway on our late-stage pipeline of product
candidates: the phase 3 studies for ALKS 3831 for schizophrenia and ALKS 8700 for multiple sclerosis will enroll throughout the
remainder of 2016, and we expect to report topline data from the FORWARD-5 study of ALKS 5461 for major depressive disorder by
year-end.”
Quarter Ended June 30, 2016 Highlights
- Total revenues for the quarter were $195.2 million. This compared to $151.4 million for the same
period in the prior year.
- Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $47.2 million,
or a basic and diluted GAAP loss per share of $0.31, for the quarter, which reflected increased investment in the company’s
advancing late-stage pipeline and commercial infrastructure. This compared to GAAP net loss of $46.1 million, or a basic and
diluted GAAP loss per share of $0.31, for the same period in the prior year.
- Non-GAAP net loss was $1.6 million, or a non-GAAP basic and diluted loss per share of $0.01, for the
quarter. This compared to non-GAAP net loss of $18.7 million, or a non-GAAP basic and diluted loss per share of $0.13, for the
same period in the prior year.
Quarter Ended June 30, 2016 Financial Results
Revenues
- Net sales of VIVITROL were $47.2 million, compared to $37.2 million for the same period in the prior
year.
- Net sales of ARISTADA were $10.3 million, up from $5.5 million in the first quarter of 2016.
- Manufacturing and royalty revenues from RISPERDAL CONSTA®, INVEGA
SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA® were $69.6 million, compared to $60.8
million for the same period in the prior year.
- Manufacturing and royalty revenues from AMPYRA®/FAMPYRA®1 were $40.8 million,
compared to $26.9 million for the same period in the prior year, reflecting the timing of shipments.
- Royalty revenue from BYDUREON® was $12.3 million, compared to $11.1 million for the same
period in the prior year.
Costs and Expenses
- Operating expenses were $242.3 million, reflecting increased investment in the company’s development
pipeline and the continued launch of ARISTADA. Operating expenses for the quarter ended June 30, 2015 were $203.9 million.
Balance Sheet
At June 30, 2016, Alkermes had cash and total investments of $677.7 million, compared to $798.8 million at Dec. 31, 2015. At
June 30, 2016, the company’s total debt outstanding was $347.0 million. Alkermes expects to pay down $60.0 million of term loan
upon maturity in September 2016. The remainder of the debt is due in September 2019.
Financial Expectations
Alkermes is updating its financial expectations for 2016 as a result of accelerating growth trends for VIVITROL, which are
driving a $10 million increase in expected revenues and a corresponding $10 million improvement in GAAP net loss. This, in addition
to certain changes to the calculation of non-GAAP measures, pursuant to guidelines issued by the Securities and Exchange Commission
(“SEC”), results in a $20 million improvement to non-GAAP net loss. The following outlines Alkermes’ updated financial expectations
for 2016.
-
Revenues: The company now expects total revenues to range from $710 million to $760 million, up from the previous range
of $700 million to $750 million.
- The company now expects VIVITROL net sales to range from $190 million to $210 million, up from a
previous range of $180 million to $200 million.
- Cost of Goods Manufactured and Sold: The company continues to expect cost of goods
manufactured and sold to range from $125 million to $135 million.
- Research and Development (R&D) Expenses: The company continues to expect R&D expenses
to range from $370 million to $400 million.
- Selling, General and Administrative (SG&A) Expenses: The company continues to expect
SG&A expenses to range from $360 million to $390 million.
- Amortization of Intangible Assets: The company continues to expect amortization of intangible
assets of approximately $60 million.
- Net Interest Expense: The company continues to expect net interest expense of approximately
$10 million.
- Net Income Tax Expense: The company continues to expect net income tax expense to range from
$0 million to $10 million.
- GAAP Net Loss: The company now expects GAAP net loss to range from $215 million to $245
million, or a basic and diluted loss per share of $1.41 to $1.61, based on weighted average basic and diluted share counts of
approximately 152 million shares outstanding. This compares to previous expectations of GAAP net loss in the range of $225
million to $255 million, or a basic and diluted loss per share of approximately $1.48 to $1.68, based on weighted average basic
and diluted share counts of approximately 152 million shares outstanding.
- Non-GAAP Net Loss: The company now expects non-GAAP net loss to range from $5 million to $35
million, or a basic and diluted loss per share of $0.03 to $0.23, based on weighted average basic and diluted share counts of
approximately 152 million shares outstanding. This compares to previous expectations of non-GAAP net loss in the range of $25
million to $55 million, or a non-GAAP diluted loss per share of $0.16 to $0.36, based on weighted average diluted share counts of
approximately 152 million shares outstanding.
- Capital Expenditures: The company continues to expect capital expenditures to be approximately
$45 million.
Conference Call
Alkermes will host a conference call at 8:30 a.m. EDT (1:30 p.m. BST) on Thursday, July 28, 2016, to discuss these financial
results and provide an update on the company. The conference call may be accessed 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. EDT (4:00 p.m. BST) on Thursday, July 28, 2016, through 5:00 p.m. EDT (10:00 p.m. BST) on
Thursday, August 4, 2016, 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
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.
Following compliance and disclosure interpretations published by the SEC in May 2016, the company made certain changes to how it
presents non-GAAP net income (loss). Non-GAAP net income (loss) in the three and six months ended June 30, 2016 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.
Previously, non-GAAP net income (loss) excluded from GAAP results: the aforementioned items; an adjustment for deferred revenue
recognized in the period; and an adjustment for non-cash tax expense, rather than the income tax effect of the reconciling items.
The company revised its presentation for certain prior periods to reflect its current non-GAAP net income (loss) methodology. A
reconciliation of the prior non-GAAP net income (loss) to the revised non-GAAP net income (loss) for such prior periods has been
provided in the tables included in this press release. The company provides the following limited reconciling items under the
previous methodology: deferred revenue of $0.5 million and non-cash taxes of $3.8 million for the quarterly period ended June 30,
2016; the company has provided this information for comparative purposes in connection with the transition to the new non-GAAP net
income (loss) methodology, and will not provide this information on an ongoing basis.
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; the likelihood of continued revenue growth from the company’s commercial
products; the therapeutic and commercial value of the company’s products; and expectations concerning the timing and results of
clinical development activities. 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: 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 U.S. Food and Drug Administration 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 Annual Report on Form 10-K
for the fiscal year ended Dec. 31, 2015, and in any other subsequent filings made by the company with the 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)
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|
Alkermes plc and Subsidiaries |
Selected Financial Information (Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
|
|
Three Months |
|
|
|
|
Ended |
|
|
|
|
Ended |
Condensed Consolidated Statements of Operations - GAAP |
|
|
|
June 30, |
|
|
|
|
June 30, |
(In thousands, except per share data) |
|
|
|
2016 |
|
|
|
|
2015 |
Revenues: |
|
|
|
|
|
|
|
|
|
Manufacturing and royalty revenues |
|
|
|
$ |
137,034 |
|
|
|
|
|
$ |
113,162 |
|
Product sales, net |
|
|
|
|
57,519 |
|
|
|
|
|
|
37,172 |
|
Research and development revenues |
|
|
|
|
612 |
|
|
|
|
|
|
1,036 |
|
Total Revenues |
|
|
|
|
195,165 |
|
|
|
|
|
|
151,370 |
|
Expenses: |
|
|
|
|
|
|
|
|
|
Cost of goods manufactured and sold |
|
|
|
|
33,998 |
|
|
|
|
|
|
30,418 |
|
Research and development |
|
|
|
|
97,007 |
|
|
|
|
|
|
87,882 |
|
Selling, general and administrative |
|
|
|
|
96,120 |
|
|
|
|
|
|
71,539 |
|
Amortization of acquired intangible assets |
|
|
|
|
15,157 |
|
|
|
|
|
|
14,052 |
|
Total Expenses |
|
|
|
|
242,282 |
|
|
|
|
|
|
203,891 |
|
Operating Loss |
|
|
|
|
(47,117 |
) |
|
|
|
|
|
(52,521 |
) |
Other (Expense) Income, net: |
|
|
|
|
|
|
|
|
|
Interest income |
|
|
|
|
994 |
|
|
|
|
|
|
795 |
|
Interest expense |
|
|
|
|
(3,323 |
) |
|
|
|
|
|
(3,315 |
) |
Gain on Gainesville Transaction |
|
|
|
|
- |
|
|
|
|
|
|
9,911 |
|
Increase in the fair value of contingent consideration |
|
|
|
|
2,200 |
|
|
|
|
|
|
1,500 |
|
Other (expense) income, net |
|
|
|
|
(467 |
) |
|
|
|
|
|
585 |
|
Total Other (Expense) Income, net |
|
|
|
|
(596 |
) |
|
|
|
|
|
9,476 |
|
Loss Before Income Taxes |
|
|
|
|
(47,713 |
) |
|
|
|
|
|
(43,045 |
) |
Income Tax (Benefit) Provision |
|
|
|
|
(520 |
) |
|
|
|
|
|
3,064 |
|
Net Loss — GAAP |
|
|
|
$ |
(47,193 |
) |
|
|
|
|
$ |
(46,109 |
) |
|
|
|
|
|
|
|
|
|
|
Net Loss Per Share: |
|
|
|
|
|
|
|
|
|
GAAP net loss per share — basic and diluted |
|
|
|
$ |
(0.31 |
) |
|
|
|
|
$ |
(0.31 |
) |
Non-GAAP net loss per share — basic and diluted |
|
|
|
$ |
(0.01 |
) |
|
|
|
|
$ |
(0.13 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted Average Number of Ordinary Shares Outstanding: |
|
|
|
|
|
|
|
|
|
Basic and diluted — GAAP and Non-GAAP |
|
|
|
|
151,301 |
|
|
|
|
|
|
148,867 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net loss is
as follows: |
|
|
|
|
|
|
|
|
|
Net Loss — GAAP |
|
|
|
$ |
(47,193 |
) |
|
|
|
|
$ |
(46,109 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
|
|
|
26,631 |
|
|
|
|
|
|
21,877 |
|
Amortization expense |
|
|
|
|
15,157 |
|
|
|
|
|
|
14,052 |
|
Depreciation expense |
|
|
|
|
7,927 |
|
|
|
|
|
|
6,584 |
|
Income tax effect related to reconciling items |
|
|
|
|
(2,051 |
) |
|
|
|
|
|
(2,531 |
) |
Non-cash net interest expense |
|
|
|
|
231 |
|
|
|
|
|
|
235 |
|
Gain on warrants and equity method investments |
|
|
|
|
(127 |
) |
|
|
|
|
|
(1,273 |
) |
Increase in the fair value of contingent consideration |
|
|
|
|
(2,200 |
) |
|
|
|
|
|
(1,500 |
) |
Gain on Gainesville Transaction |
|
|
|
|
- |
|
|
|
|
|
|
(9,911 |
) |
Gain on sale of property, plant and equipment |
|
|
|
|
- |
|
|
|
|
|
|
(114 |
) |
Non-GAAP Net Loss |
|
|
|
$ |
(1,625 |
) |
|
|
|
|
$ |
(18,690 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months |
|
|
|
|
Six Months |
|
|
|
|
Ended |
|
|
|
|
Ended |
Condensed Consolidated Statements of Operations - GAAP |
|
|
|
June 30, |
|
|
|
|
June 30, |
(In thousands, except per share data) |
|
|
|
2016 |
|
|
|
|
2015 |
Revenues: |
|
|
|
|
|
|
|
|
|
Manufacturing and royalty revenues |
|
|
|
$ |
243,194 |
|
|
|
|
|
$ |
241,906 |
|
Product sales, net |
|
|
|
|
106,893 |
|
|
|
|
|
|
68,309 |
|
Research and development revenues |
|
|
|
|
1,853 |
|
|
|
|
|
|
2,369 |
|
Total Revenues |
|
|
|
|
351,940 |
|
|
|
|
|
|
312,584 |
|
Expenses: |
|
|
|
|
|
|
|
|
|
Cost of goods manufactured and sold |
|
|
|
|
61,709 |
|
|
|
|
|
|
70,392 |
|
Research and development |
|
|
|
|
198,079 |
|
|
|
|
|
|
158,160 |
|
Selling, general and administrative |
|
|
|
|
185,840 |
|
|
|
|
|
|
134,589 |
|
Amortization of acquired intangible assets |
|
|
|
|
30,313 |
|
|
|
|
|
|
29,272 |
|
Total Expenses |
|
|
|
|
475,941 |
|
|
|
|
|
|
392,413 |
|
Operating Loss |
|
|
|
|
(124,001 |
) |
|
|
|
|
|
(79,829 |
) |
Other (Expense) Income, net: |
|
|
|
|
|
|
|
|
|
Interest income |
|
|
|
|
2,005 |
|
|
|
|
|
|
1,455 |
|
Interest expense |
|
|
|
|
(6,618 |
) |
|
|
|
|
|
(6,603 |
) |
Gain on Gainesville Transaction |
|
|
|
|
- |
|
|
|
|
|
|
9,911 |
|
Increase in the fair value of contingent consideration |
|
|
|
|
4,100 |
|
|
|
|
|
|
1,500 |
|
Other (expense) income, net |
|
|
|
|
(218 |
) |
|
|
|
|
|
374 |
|
Total Other (Expense) Income, net |
|
|
|
|
(731 |
) |
|
|
|
|
|
6,637 |
|
Loss Before Income Taxes |
|
|
|
|
(124,732 |
) |
|
|
|
|
|
(73,192 |
) |
Income Tax (Benefit) Provision |
|
|
|
|
(116 |
) |
|
|
|
|
|
3,574 |
|
Net Loss — GAAP |
|
|
|
$ |
(124,616 |
) |
|
|
|
|
$ |
(76,766 |
) |
|
|
|
|
|
|
|
|
|
|
Net Loss Per Share: |
|
|
|
|
|
|
|
|
|
GAAP net loss per share — basic and diluted |
|
|
|
$ |
(0.82 |
) |
|
|
|
|
$ |
(0.52 |
) |
Non-GAAP net loss per share — basic and diluted |
|
|
|
$ |
(0.13 |
) |
|
|
|
|
$ |
(0.05 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted Average Number of Ordinary Shares Outstanding: |
|
|
|
|
|
|
|
|
|
Basic and diluted — GAAP and Non-GAAP |
|
|
|
|
151,063 |
|
|
|
|
|
|
148,480 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net loss is
as follows: |
|
|
|
|
|
|
|
|
|
Net Loss — GAAP |
|
|
|
$ |
(124,616 |
) |
|
|
|
|
$ |
(76,766 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
|
|
|
50,887 |
|
|
|
|
|
|
39,206 |
|
Amortization expense |
|
|
|
|
30,313 |
|
|
|
|
|
|
29,272 |
|
Depreciation expense |
|
|
|
|
15,475 |
|
|
|
|
|
|
13,850 |
|
Income tax effect related to reconciling items |
|
|
|
|
1,289 |
|
|
|
|
|
|
140 |
|
Loss (gain) on warrants and equity method investments |
|
|
|
|
743 |
|
|
|
|
|
|
(1,670 |
) |
Non-cash net interest expense |
|
|
|
|
463 |
|
|
|
|
|
|
471 |
|
Upfront license option payment to Reset Therapeutics, Inc. charged to R&D
expense |
|
|
|
|
10,000 |
|
|
|
|
|
|
- |
|
Increase in the fair value of contingent consideration |
|
|
|
|
(4,100 |
) |
|
|
|
|
|
(1,500 |
) |
Gain on Gainesville Transaction |
|
|
|
|
- |
|
|
|
|
|
|
(9,911 |
) |
Gain on sale of property, plant and equipment |
|
|
|
|
- |
|
|
|
|
|
|
(114 |
) |
Non-GAAP Net Loss |
|
|
|
$ |
(19,546 |
) |
|
|
|
|
$ |
(7,022 |
) |
|
|
|
|
|
|
|
|
|
|
|
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 income (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 |
|
|
|
June 30, |
|
|
|
|
December 31, |
(In thousands) |
|
|
|
2016 |
|
|
|
|
2015 |
Cash, cash equivalents and total investments |
|
|
|
$ |
677,671 |
|
|
|
|
$ |
798,849 |
Receivables |
|
|
|
|
185,008 |
|
|
|
|
|
155,487 |
Inventory |
|
|
|
|
49,896 |
|
|
|
|
|
38,411 |
Prepaid expenses and other current assets |
|
|
|
|
38,369 |
|
|
|
|
|
26,286 |
Property, plant and equipment, net |
|
|
|
|
258,354 |
|
|
|
|
|
254,819 |
Intangible assets, net and goodwill |
|
|
|
|
441,746 |
|
|
|
|
|
472,059 |
Other assets |
|
|
|
|
134,242 |
|
|
|
|
|
109,833 |
Total Assets |
|
|
|
$ |
1,785,286 |
|
|
|
|
$ |
1,855,744 |
Long-term debt — current portion |
|
|
|
$ |
63,913 |
|
|
|
|
$ |
65,737 |
Other current liabilities |
|
|
|
|
172,350 |
|
|
|
|
|
170,470 |
Long-term debt |
|
|
|
|
283,120 |
|
|
|
|
|
284,207 |
Deferred revenue — long-term |
|
|
|
|
6,943 |
|
|
|
|
|
7,975 |
Other long-term liabilities |
|
|
|
|
15,434 |
|
|
|
|
|
13,080 |
Total shareholders' equity |
|
|
|
|
1,243,526 |
|
|
|
|
|
1,314,275 |
Total Liabilities and Shareholders' Equity |
|
|
|
$ |
1,785,286 |
|
|
|
|
$ |
1,855,744 |
|
|
|
|
|
|
|
|
|
|
Ordinary shares outstanding (in thousands) |
|
|
|
|
151,503 |
|
|
|
|
|
150,701 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto
included in Alkermes plc's Quarterly Report on Form 10-Q for the three and six months ended June 30, 2016, which the company
intends to file in July 2016.
|
|
|
|
|
|
|
|
|
|
|
|
|
2016 Guidance — GAAP to Non-GAAP Adjustments |
|
|
|
|
|
|
|
|
|
|
|
|
|
An itemized reconciliation between projected loss per
share on a GAAP basis and projected loss per share on a non-GAAP basis is as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In millions, except per share data) |
|
|
|
Amount |
|
|
|
Shares |
|
|
|
Loss Per Share |
Projected Net Loss — GAAP |
|
|
|
$ |
(230.0 |
) |
|
|
|
152 |
|
|
|
$ |
(1.51 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash net interest expense |
|
|
|
|
1.0 |
|
|
|
|
|
|
|
|
|
Income taxes |
|
|
|
|
5.0 |
|
|
|
|
|
|
|
|
|
Depreciation expense |
|
|
|
|
32.5 |
|
|
|
|
|
|
|
|
|
Amortization expense |
|
|
|
|
60.0 |
|
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
|
|
|
101.5 |
|
|
|
|
|
|
|
|
|
Upfront license option payment to Reset Therapeutics, Inc. charged to R&D
expense |
|
|
|
|
10.0 |
|
|
|
|
|
|
|
|
|
Projected Non-GAAP Net Loss |
|
|
|
$ |
(20.0 |
) |
|
|
|
152 |
|
|
|
$ |
(0.13 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Projected GAAP and non-GAAP measures reflect mid-points within ranges of estimated guidance.
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 revised guidance above includes
the impact of these items, in addition to an adjustment related to the $10 million license option payment to Reset Therapeutics,
Inc. and an $11 million reduction to share-based compensation expense.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Reconciliation from Prior to Current Presentation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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. The following reconciliation shows the effect of this change in presentation of non-GAAP net income (loss) for
each of the quarters in the year ended December 31, 2015, the year ended December 31, 2015 and the quarter ended March 31,
2016: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Three Months |
|
|
Three Months |
|
|
Three Months |
|
|
Year |
|
|
|
Three Months |
|
|
|
Ended |
|
|
Ended |
|
|
Ended |
|
|
Ended |
|
|
Ended |
|
|
|
Ended |
|
|
|
March 31, |
|
|
June 30, |
|
|
September 30, |
|
|
December 31, |
|
|
December 31, |
|
|
|
March 31, |
|
|
|
2015 |
|
|
2015 |
|
|
2015 |
|
|
2015 |
|
|
2015 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Net Income (Loss) — as previously reported |
|
|
$ |
9,157 |
|
|
|
$ |
(13,585 |
) |
|
|
$ |
(26,174 |
) |
|
|
$ |
(22,629 |
) |
|
|
$ |
(53,231 |
) |
|
|
|
$ |
(24,566 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Removal of the adjustment for deferred revenue |
|
|
|
328 |
|
|
|
|
460 |
|
|
|
|
384 |
|
|
|
|
(542 |
) |
|
|
|
630 |
|
|
|
|
|
442 |
|
Removal of the adjustment for non-cash taxes |
|
|
|
(488 |
) |
|
|
|
(3,034 |
) |
|
|
|
(677 |
) |
|
|
|
2,790 |
|
|
|
|
(1,409 |
) |
|
|
|
|
2,863 |
|
Adjustment for the income tax effect of other non-GAAP adjustments |
|
|
|
2,671 |
|
|
|
|
(2,531 |
) |
|
|
|
(2,344 |
) |
|
|
|
(618 |
) |
|
|
|
(2,822 |
) |
|
|
|
|
3,340 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Net Income (Loss) — revised |
|
|
$ |
11,668 |
|
|
|
$ |
(18,690 |
) |
|
|
$ |
(28,811 |
) |
|
|
$ |
(20,999 |
) |
|
|
$ |
(56,832 |
) |
|
|
|
$ |
(17,921 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Increase (Decrease) From Previously Reported Non-GAAP Net Income
(Loss) |
|
|
$ |
2,511 |
|
|
|
$ |
(5,105 |
) |
|
|
$ |
(2,637 |
) |
|
|
$ |
1,630 |
|
|
|
$ |
(3,601 |
) |
|
|
|
$ |
6,645 |
|
Alkermes Contacts:
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/20160728005241/en/