"Our first quarter results reflect the diversity of our business, as the growth of VIVITROL® net sales and royalty revenues from INVEGA SUSTENNA® offset a decline in AMPYRA® royalties, following generic entry in the market. As is typical, during the first quarter we saw the effect of seasonal inventory fluctuations and deductible resets for commercial payer plans impact net sales of our proprietary commercial products, which decreased sequentially. In particular, ARISTADA® net sales were impacted more than anticipated by inventory fluctuations which masked underlying prescription growth of approximately 5% compared to last quarter," commented
"The first few months of 2019 were highlighted by the presentation of important new data from large clinical trials of both ALKS 3831 and ARISTADA at the 2019
Quarter Ended
- Total revenues for the quarter were
$223.1 million , compared to$225.2 million for the same period in the prior year, reflecting the growth in our proprietary product net sales and an offsetting decrease in AMPYRAi revenues following generic entry into the market in 2018. - Net loss according to generally accepted accounting principles in the U.S. (GAAP) was
$96.4 million for the quarter, or a basic and diluted GAAP net loss per share of$0.62 . This compared to GAAP net loss of$62.5 million , or a basic and diluted GAAP net loss per share of$0.40 for the same period in the prior year. - Non-GAAP net loss was
$26.0 million for the quarter, or a non-GAAP basic and diluted net loss per share of$0.17 . This compared to non-GAAP net loss of$14.2 million , or a non-GAAP basic and diluted net loss per share of$0.09 for the same period in the prior year.
Quarter Ended
Revenues
- Net sales of VIVITROL were
$69.2 million , compared to$62.7 million for the same period in the prior year, representing an increase of approximately 10%. - Net sales of ARISTADAii were
$30.3 million , compared to$29.2 million for the same period in the prior year, representing an increase of approximately 4%. - Manufacturing and royalty revenues from RISPERDAL CONSTA®, INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA® were
$75.6 million , compared to$68.8 million for the same period in the prior year. - Manufacturing and royalty revenues from AMPYRA/FAMPYRA® were
$12.2 million , compared to$28.3 million for the same period in the prior year due to generic competition to AMPYRA entering the market in late 2018. - Research and development revenues from the collaboration with Biogen for diroximel fumarate (BIIB098) were
$13.9 million , compared to$17.5 million for the same period in the prior year.
Costs and Expenses
- Operating expenses were
$299.1 million , compared to$287.0 million for the same period in the prior year, primarily reflecting increased investment in the commercialization of VIVITROL and ARISTADA. - Other expense during the quarter included a
$22.6 million charge due to a decrease in the fair value of contingent consideration, related toRecro Pharma, Inc.'s receipt of a second complete response letter from theUnited States (U.S.) Food and Drug Administration (FDA ) regarding the New Drug Application (NDA) for IV Meloxicam.
Financial Expectations for 2019
Recent Events:
- Leadership
- Appointed
Todd Nichols to the role of Senior Vice President of Sales and Marketing. Mr. Nichols joinsAlkermes fromCelgene and his responsibilities will include leading global commercial activities, including marketing and sales of VIVITROL and ARISTADA, as well as developing and executing the commercial strategy for ALKS 3831 and other development candidates. - ARISTADA
The U.S. Department of Veterans Affairs recently added ARISTADA and ARISTADA INITIO® to its National Formulary at parity with other long-acting injectable atypical antipsychotics.- Announced positive topline results from ALPINE (Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness), a six-month study evaluating the efficacy, safety and tolerability of ARISTADA and INVEGA SUSTENNA, when used to initiate patients experiencing an acute exacerbation of schizophrenia in the hospital and maintain treatment in an outpatient setting. Results were presented at the 2019
Congress of theSchizophrenia International Research Society (SIRS). - ALKS 3831
- Presented new data at SIRS from the phase 3 ALKS 3831 ENLIGHTEN-2 six-month weight study and interim results from the ENLIGHTEN-2 52-week safety extension study.
- Diroximel fumarate
- Announced that the
FDA accepted for review the NDA for diroximel fumarate. If approved, Biogen intends to market diroximel fumarate under the brand name VUMERITY™, which has been conditionally accepted by theFDA and would be confirmed upon approval. - ALKS 4230
- Initiated ARTISTRY-2, a new clinical study of ALKS 4230 administered subcutaneously as monotherapy and in combination with the PD-1 inhibitor KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors.
- Announced a research collaboration with Clovis to evaluate ALKS 4230 in combination with rucaparib, Clovis' marketed PARP inhibitor, and lucitanib, Clovis' investigational tyrosine kinase inhibitor.
Conference Call
About
Non-GAAP Financial Measures
This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the U.S. (GAAP), including non-GAAP net loss and non-GAAP basic and diluted 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 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 loss and non-GAAP basic and diluted 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 loss and non-GAAP basic and diluted 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; expectations concerning the company's continued investment in its development pipeline and commercial capabilities and the value that can be derived therefrom; the potential therapeutic and commercial value of the company's marketed and development products; expectations concerning the timing and results of clinical development and regulatory activities, including the planned submission of an NDA for ALKS 3831, the
VIVITROL® is a registered trademark of
(tables follow)
i AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg is developed and marketed in the U.S. by Acorda.
ii The term "ARISTADA" as used in this press release refers to ARISTADA and ARISTADA INITIO, unless the context indicates otherwise.
Alkermes plc and Subsidiaries |
||||
Selected Financial Information (Unaudited) |
||||
Condensed Consolidated Statements of Operations - GAAP |
Three Months |
Three Months |
||
March 31, |
March 31, |
|||
(In thousands, except per share data) |
2019 |
2018 |
||
Revenues: |
||||
Manufacturing and royalty revenues |
$ 108,915 |
$ 114,601 |
||
Product sales, net |
99,481 |
91,842 |
||
Research and development revenue |
14,706 |
18,707 |
||
Total Revenues |
223,102 |
225,150 |
||
Expenses: |
||||
Cost of goods manufactured and sold |
45,361 |
44,476 |
||
Research and development |
102,570 |
108,346 |
||
Selling, general and administrative |
141,220 |
118,147 |
||
Amortization of acquired intangible assets |
9,952 |
16,069 |
||
Total Expenses |
299,103 |
287,038 |
||
Operating Loss |
(76,001) |
(61,888) |
||
Other Expense, net: |
||||
Interest income |
3,570 |
1,485 |
||
Interest expense |
(3,500) |
(5,487) |
||
Change in the fair value of contingent consideration |
(22,600) |
(1,900) |
||
Other expense, net |
(1,721) |
792 |
||
Total Other Expense, net |
(24,251) |
(5,110) |
||
Loss Before Income Taxes |
(100,252) |
(66,998) |
||
Income Tax Benefit |
(3,854) |
(4,493) |
||
Net Loss — GAAP |
$ (96,398) |
$ (62,505) |
||
Net Loss Per Share: |
||||
GAAP net loss per share — basic and diluted |
$ (0.62) |
$ (0.40) |
||
Non-GAAP net loss per share — basic and diluted |
$ (0.17) |
$ (0.09) |
||
Weighted Average Number of Ordinary Shares Outstanding: |
||||
Basic and diluted — GAAP and Non-GAAP |
156,336 |
154,424 |
||
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net loss is as follows: |
||||
Net Loss — GAAP |
$ (96,398) |
$ (62,505) |
||
Adjustments: |
||||
Share-based compensation expense |
24,616 |
20,042 |
||
Amortization expense |
9,952 |
16,069 |
||
Depreciation expense |
9,690 |
9,653 |
||
Change in the fair value of contingent consideration |
22,600 |
1,900 |
||
Income tax effect related to reconciling items |
2,972 |
(5,178) |
||
Non-cash net interest expense |
169 |
191 |
||
Change in the fair value of warrants and equity method investments |
433 |
(302) |
||
Restructuring expense |
— |
3,598 |
||
Debt refinancing charge |
— |
2,298 |
||
Non-GAAP Net Loss |
$ (25,966) |
$ (14,234) |
||
Condensed Consolidated Balance Sheets |
March 31, |
December 31, |
||
(In thousands) |
2019 |
2018 |
||
Cash, cash equivalents and total investments |
$ 625,133 |
$ 620,039 |
||
Receivables |
222,811 |
292,223 |
||
Contract assets |
8,447 |
8,230 |
||
Inventory |
92,861 |
90,196 |
||
Prepaid expenses and other current assets |
56,492 |
53,308 |
||
Property, plant and equipment, net |
320,004 |
309,987 |
||
Intangible assets, net and goodwill |
273,922 |
283,874 |
||
Other assets |
156,866 |
167,150 |
||
Total Assets |
$ 1,756,536 |
$ 1,825,007 |
||
Long-term debt — current portion |
$ 2,843 |
$ 2,843 |
||
Other current liabilities |
324,842 |
336,931 |
||
Long-term debt |
275,923 |
276,465 |
||
Contract liabilities — long-term |
11,342 |
9,525 |
||
Other long-term liabilities |
39,445 |
27,958 |
||
Total shareholders' equity |
1,102,141 |
1,171,285 |
||
Total Liabilities and Shareholders' Equity |
$ 1,756,536 |
$ 1,825,007 |
||
Ordinary shares outstanding (in thousands) |
156,885 |
155,757 |
||
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 months ended March 31, 2019, which the company intends to file in April 2019. |
Alkermes Contacts:
For Investors: Sandy Coombs +1 781 609 6377
For Media:
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