Log in
E-mail
Password
Show password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Settings
Settings
Dynamic quotes 
OFFON
  1. Homepage
  2. Equities
  3. United States
  4. Nasdaq
  5. Alkermes plc
  6. News
  7. Summary
    ALKS   IE00B56GVS15

ALKERMES PLC

(ALKS)
  Report
SummaryQuotesChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisions 
SummaryMost relevantAll NewsAnalyst Reco.Other languagesPress ReleasesOfficial PublicationsSector news

Alkermes : Reports Second Quarter 2021 Financial Results (Form 8-K)

07/28/2021 | 07:14am EDT

Alkermes plc Reports Second Quarter 2021 Financial Results

- Second Quarter Revenues of $303.7 Million Reflect 23% Growth Year-Over-Year -

- Diluted GAAP Earnings per Share of $0.01 and Diluted Non-GAAP Earnings per Share of $0.30, Driven by Operational Execution -

-Company Updates Full-Year 2021 Financial Expectations Based on Strong First Half Performance -

DUBLIN, July 28, 2021 -Alkermes plc (Nasdaq: ALKS) today reported financial results for the second quarter of 2021 and provided updated financial expectations for full-year 2021.

'Alkermes' strong performance in the second quarter was driven by commercial execution and our focus on profitability. VIVITROL® and ARISTADA® demonstrated robust sequential and year-over-year growth and VUMERITY® continued on an encouraging launch trajectory,' commented Iain Brown, Chief Financial Officer of Alkermes. 'Today, we are raising our financial expectations for full-year 2021 to reflect this performance and anticipated continued strength in the business. We believe that we are in a sound financial position to execute on our business strategy and efficiently invest in our future potential growth drivers.'

Quarter Ended June 30, 2021 Financial Results

Revenues

Total revenues for the quarter were $303.7 million. This compared to $247.5 million for the same period in the prior year.

Net sales of proprietary products for the quarter were $160.8 million, compared to $130.4 million for the same period in the prior year.

o

Net sales of VIVITROL were $88.4 million, compared to $71.6 million for the same period in the prior year, representing an increase of approximately 23%.

o

Net sales of ARISTADA1 were $72.4 million, compared to $58.8 million for the same period in the prior year, representing an increase of approximately 23%.

Manufacturing and royalty revenues for the quarter were $142.3 million, compared to $116.5 million for the same period in the prior year.

o

Manufacturing and royalty revenues from RISPERDAL CONSTA®, INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA® were $95.5 million, compared to $83.1 million for the same period in the prior year.

o

Manufacturing and royalty revenues from VUMERITY® were $20.3 million, compared to $2.6 million for the same period in the prior year.

Costs and Expenses

Total operating expenses for the quarter were $299.3 million, compared to $281.2 million for the same period in the prior year.

o

Cost of Goods Manufactured and Sold were $53.1 million, compared to $45.1 million for the same period in the prior year.

o

Research and Development (R&D) expenses were $97.5 million, compared to $94.2 million for the same period in the prior year.

o

Selling, General and Administrative (SG&A) expenses were $139.2 million, compared to $132.0 million for the same period in the prior year.

Profitability

Net income according to generally accepted accounting principles in the U.S. (GAAP) was $2.4 million for the quarter, or a basic and diluted GAAP earnings per share of $0.01. This compared to GAAP net loss of $29.4 million, or a basic and diluted GAAP loss per share of $0.19, for the same period in the prior year.

Non-GAAP net income was $49.2 million for the quarter, or a non-GAAP basic earnings per share of $0.31 and a non-GAAP diluted earnings per share of $0.30. This compared to non-GAAP net income of $8.9 million, or a non-GAAP basic and diluted earnings per share of $0.06 for the same period in the prior year.

Balance Sheet

At June 30, 2021, the company recorded cash, cash equivalents and total investments of $669.4 million, compared to $627.4 million at March 31, 2021, driven primarily by the company's operating results and changes in working capital. The company's total debt outstanding as of June 30, 2021 was $297.1 million.

Financial Expectations for 2021

The following financial expectations for 2021 are based on recent trends and assume continued improvement in patient access to treatment providers and to the company's commercial products in the second half of the year. If patient access does not improve as anticipated, or if new COVID-19-related disruptions emerge, the company's ability to meet these expectations could be negatively impacted. All line items are according to GAAP, except as otherwise noted.

In millions (except per share amounts)

Current 2021 Expectation

(Provided 7/28/21)

Prior 2021 Expectation

(Provided 2/11/21)

Total Revenue

$1,145 - $1,185

$1,100 - $1,170

VIVITROL Net Sales

$330 - $345

$315 - $345

ARISTADA Net Sales

$275 - $290

$260 - $290

LYBALVI® Net Sales

Cost of Goods Sold

$195 - $205

$190 - $200

R&D Expenses

$400 - $430*

$400 - $430*

SG&A Expenses

$560 - $590

$570 - $600

Amortization of Intangible Assets

~$40

~$40

Other Expense, Net

$0 - $5

$0

Income Tax Expense

$5 - $10

$0 - $10

GAAP Net Loss

($60) - ($90)

($85) - ($125)

GAAP Net Loss per Share+

($0.37) - ($0.56)

($0.53) - ($0.78)

Non-GAAP Net Income

$85 - $115

$60 - $100

Non-GAAP Diluted EPS+

$0.52 - $0.70

$0.37 - $0.62

Capital Expenditures

~$35

~$40

*R&D expense expectations for 2021 include an anticipated $25 million milestone payment in the third quarter to the former shareholders of Rodin Therapeutics, Inc. related to the expected submission of an investigational new drug application, or equivalent, for ALKS 1140, the first clinical candidate to emerge from the histone deacetylase (HDAC) inhibitor platform acquired by the company in late 2019.

+ The current 2021 per share expectations are calculated based on a weighted average basic share count of approximately 161 million shares outstanding and a weighted average diluted share count of approximately 164 million shares outstanding, as compared to prior expectations of approximately 160 million and 161 million, respectively.

2

'Our achievements in the second quarter demonstrated continued execution against our strategic priorities. Our strong commercial performance, the FDA approval of LYBALVI and the accumulating data and operational progress in our nemvaleukin immuno-oncology program represent important milestones for the company and provide a meaningful platform to drive future growth,' said Richard Pops, Chief Executive Officer of Alkermes. 'Guided by our intense focus on value creation, our objectives for the remainder of 2021 are clear: successfully launch LYBALVI; drive the growth of VIVITROL and ARISTADA; advance the clinical development program for nemvaleukin; and invest in our emerging neuroscience and oncology pipeline assets.'

Recent Events:

Psychiatry

In June 2021, the company announced FDA approval of LYBALVI (olanzapine and samidorphan) for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate2. LYBALVI is a once-daily, oral atypical antipsychotic composed of olanzapine, an established antipsychotic agent, co-formulated with samidorphan, a new chemical entity, in a single bilayer tablet.

Nemvaleukin alfa ('nemvaleukin')

In June 2021, the company presented updated data from the ARTISTRY clinical development program for nemvaleukin, the company's novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy, at the American Society of Clinical Oncology (ASCO) Annual Meeting. In conjunction with the data presentation at ASCO, the company hosted an investor webcast with ARTISTRY clinical program investigators Valentina Boni, M.D., Ph.D., Medical Oncologist and Principal Investigator at START Madrid at Centro Integral Oncológico Clara Campal and Omid Hamid, M.D., Chief of Research and Immunotherapy at The Angeles Clinic and Research Institute.

Corporate

In May 2021, the company announced the appointment of Emily Peterson Alva to the company's Board of Directors (the Board). Ms. Alva is an experienced public company board member and a financial, strategic and business advisor to growth companies. Ms. Alva is the fifth new, independent director to join the Board in the past two years.

In July 2021, the company awarded grants from its Alkermes Inspiration Grants® program to 11 nonprofit organizations working to address the needs of people living with addiction, serious mental illness or cancer.

Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, July 28, 2021, 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 may be accessed by visiting Alkermes' website.

3

About Alkermes plc

Alkermes plc is a fully-integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for neurodegenerative disorders and cancer. 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 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 certain 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 the company's liquidity.

A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release.

Note Regarding Forward-Looking Statements

Certain statements set forth in this press release constitute 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company's expectations concerning future financial and operating performance, business plans or prospects, including the expected drivers of future growth and value creation; expectations of continued improvement in patient access to healthcare providers and to the company's commercial products; the potential therapeutic and commercial value of the company's marketed and development products; expectations concerning the company's future development activities, including plans for submission of an investigational new drug application or equivalent for ALKS 1140, advancement of the clinical development program for nemvaleukin and further investment in the company's neuroscience and oncology development pipeline; and expectations concerning the company's commercial activities, including the anticipated launch of LYBALVI. The company cautions that forward-looking statements are inherently uncertain. 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 company may not be able to achieve its targeted financial and profitability metrics in a timely manner or at all; the impacts of the ongoing COVID-19 pandemic and continued efforts to mitigate its spread on the company's business, results of operations or financial condition, including impacts on healthcare systems

4

and patient and healthcare provider access to the company's commercial products and impacts on the regulatory agencies with which the company interacts in the development, review, approval and commercialization of its medicines; the unfavorable outcome of litigation, including so-called 'Paragraph IV' litigation and other patent litigation, or other disputes related to our products or products using our proprietary technologies; clinical development activities may not be completed on time or at all; the results of the company's development activities may not be positive, or predictive of final results from such activities, results of future development activities or real-world results; 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 and the adequacy of the data and other information included in our submissions to support the FDA's requirements for approval; regulatory submissions may not occur or be submitted in a timely manner; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; 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 government payers; 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 year ended Dec. 31, 2020 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 atwww.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, and ALKERMES INSPIRATION GRANTS® is a registered service mark, of Alkermes, Inc.; ARISTADA®, ARISTADA INITIO® and LYBALVI® are registered trademarks of Alkermes Pharma Ireland Limited; RISPERDAL CONSTA®, INVEGA SUSTENNA®, XEPLION®, INVEGA TRINZA® and TREVICTA® are registered trademarks of Johnson & Johnson; and VUMERITY® is a registered trademark of Biogen Inc., used by Alkermes under license.

(tables follow)

1

The term 'ARISTADA' as used in this press release refers to ARISTADA and ARISTADA INITIO®, unless the context indicates otherwise.

2

Full prescribing information, including boxed warning, for LYBALVI may be found at www.lybalvi.com/lybalvi-prescribing-information.pdf

Alkermes plc and Subsidiaries

Selected Financial Information (Unaudited)

Condensed Consolidated Statements of Operations - GAAP

Three Months Ended

Three Months Ended

(In thousands, except per share data)

June 30, 2021

June 30, 2020

Revenues:

Product sales, net

$

160,808

$

130,415

Manufacturing and royalty revenues

142,294

116,505

Research and development revenue

615

609

Total Revenues

303,717

247,529

Expenses:

Cost of goods manufactured and sold

53,124

45,053

Research and development

97,473

94,222

Selling, general and administrative

139,188

132,025

Amortization of acquired intangible assets

9,511

9,890

Total Expenses

299,296

281,190

Operating Income (Loss)

4,421

(33,661

)

Other Income, net:

Interest income

623

1,788

Interest expense

(2,407

)

(2,122

)

Change in the fair value of contingent consideration

3,240

5,900

Other (expense) income, net

(222

)

2,337

Total Other Income, net

1,234

7,903

Income (Loss) Before Income Taxes

5,655

(25,758

)

Provision for Income Taxes

3,291

3,673

Net Income (Loss) - GAAP

$

2,364

$

(29,431

)

Earnings (Loss) Per Share:

GAAP earnings (loss) per share - basic and diluted

$

0.01

$

(0.19

)

Non-GAAP earnings per share - basic

$

0.31

$

0.06

Non-GAAP earnings per share - diluted

$

0.30

$

0.06

Weighted Average Number of Ordinary Shares Outstanding:

Basic - GAAP

160,817

158,895

Diluted - GAAP

163,937

158,895

Basic - Non-GAAP

160,817

158,895

Diluted - Non-GAAP

163,937

159,275

An itemized reconciliation between net income (loss) on a GAAP basis and non-GAAP net income is as follows:

Net Income (Loss) - GAAP

$

2,364

$

(29,431

)

Adjustments:

Share-based compensation expense

27,552

22,846

Depreciation expense

8,966

10,447

Amortization expense

9,511

9,890

Income tax effect related to reconciling items

3,927

877

Non-cash net interest expense

117

167

Change in the fair value of contingent consideration

(3,240

)

(5,900

)

Non-GAAP Net Income

$

49,197

$

8,896

5

Alkermes plc and Subsidiaries

Selected Financial Information (Unaudited)

Condensed Consolidated Statements of Operations - GAAP

Six Months Ended

Six Months Ended

(In thousands, except per share data)

June 30, 2021

June 30, 2020

Revenues:

Product sales, net

$

290,771

$

260,141

Manufacturing and royalty revenues

262,141

232,756

License revenue

1,500

-

Research and development revenue

735

852

Total Revenues

555,147

493,749

Expenses:

Cost of goods manufactured and sold

94,144

92,264

Research and development

189,741

187,501

Selling, general and administrative

264,356

265,397

Amortization of acquired intangible assets

18,917

19,618

Total Expenses

567,158

564,780

Operating Loss

(12,011

)

(71,031

)

Other (Expense) Income, net:

Interest income

1,487

4,548

Interest expense

(6,377

)

(4,979

)

Change in the fair value of contingent consideration

4,518

12,700

Other (expense) income, net

(615

)

1,679

Total Other (Expense) Income, net

(987

)

13,948

Loss Before Income Taxes

(12,998

)

(57,083

)

Provision for Income Taxes

7,056

11,002

Net Loss - GAAP

$

(20,054

)

$

(68,085

)

(Loss) Earnings Per Share:

GAAP loss per share - basic and diluted

$

(0.13

)

$

(0.43

)

Non-GAAP earnings per share - basic

$

0.42

$

0.07

Non-GAAP earnings per share - diluted

$

0.41

$

0.07

Weighted Average Number of Ordinary Shares Outstanding:

Basic and diluted - GAAP

160,229

158,495

Basic - Non-GAAP

160,229

158,495

Diluted - Non-GAAP

163,174

159,151

An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income is as follows:

Net Loss - GAAP

$

(20,054

)

$

(68,085

)

Adjustments:

Share-based compensation expense

43,003

42,659

Depreciation expense

19,203

21,328

Amortization expense

18,917

19,618

Income tax effect related to reconciling items

8,106

6,797

Non-cash net interest expense

235

334

Debt refinancing charge

2,109

-

Change in the fair value of contingent consideration

(4,518

)

(12,700

)

Acquisition of IPR&D

-

674

Non-GAAP Net Income

$

67,001

$

10,625

Alkermes plc and Subsidiaries

Selected Financial Information (Unaudited)

Condensed Consolidated Balance Sheets

June 30,

December 31,

(In thousands)

2021

2020

Cash, cash equivalents and total investments

$

669,377

$

659,807

Receivables

297,357

275,143

Contract assets

8,793

14,401

Inventory

136,077

125,738

Prepaid expenses and other current assets

57,186

60,662

Property, plant and equipment, net

343,949

350,003

Intangible assets, net and goodwill

186,147

204,064

Other assets

238,683

259,912

Total Assets

$

1,937,569

$

1,949,730

Long-term debt - current portion

$

3,000

$

2,843

Other current liabilities

380,442

435,415

Long-term debt

294,070

272,118

Contract liabilities - long-term

14,167

16,397

Other long-term liabilities

147,988

155,975

Total shareholders' equity

1,097,902

1,066,982

Total Liabilities and Shareholders' Equity

$

1,937,569

$

1,949,730

Ordinary shares outstanding (in thousands)

161,296

159,161

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, 2021, which the company intends to file in July 2021.

Alkermes plc and Subsidiaries

2021 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

$

(75.0

)

161

$

(0.47

)

Adjustments:

Share-based compensation expense

90.0

Depreciation expense

42.0

Amortization expense

40.0

Income tax effect related to reconciling items

5.0

Other income (expense), net

2.0

Non-cash net interest expense

1.0

Change in the fair value of contingent consideration

(5.0

)

Projected Net Income - Non-GAAP

$

100.0

164

$

0.61

Projected GAAP and non-GAAP measures reflect mid-points within ranges of estimated guidance.

Disclaimer

Alkermes plc published this content on 28 July 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 28 July 2021 11:13:05 UTC.


ę Publicnow 2021
All news about ALKERMES PLC
09/23ALKERMES : New Survey Provides Insights Into Drinking Behaviors During the Pandemic
AQ
09/22ALKERMES : to Take Part in the Cantor Virtual Global Healthcare Conference
PR
09/22ALKERMES : New Survey Provides Insights Into Drinking Behaviors During the Pandemic
PR
09/13ALKERMES : to Present Two Posters on Investigational Immuno-oncology Candidate, Nemvaleuki..
PR
09/10ALKERMES : Announces Launch of 4th Annual Alkermes Pathways Research Awards Program
AQ
09/09ALKERMES : Announces Launch of 4th Annual Alkermes Pathways Research Awards« Program
PR
09/02ALKERMES : to Take Part in the Citi Annual BioPharma Virtual Conference
PR
09/02ALKERMES : BofA Securities Downgrades Alkermes to Underperform from Neutral on Risk/Reward..
MT
09/02ALKERMES : BofA Securities Downgrades Alkermes to Underperform from Neutral, Adjusts Price..
MT
08/04INSIDER TRENDS : Alkermes Insider 90-Day Buying Trend Prolonged with Purchase
MT
More news
Analyst Recommendations on ALKERMES PLC
More recommendations
Financials (USD)
Sales 2021 1 173 M - -
Net income 2021 -80,0 M - -
Net cash 2021 384 M - -
P/E ratio 2021 -66,0x
Yield 2021 -
Capitalization 5 148 M 5 148 M -
EV / Sales 2021 4,06x
EV / Sales 2022 3,59x
Nbr of Employees 2 245
Free-Float 96,7%
Chart ALKERMES PLC
Duration : Period :
Alkermes plc Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends ALKERMES PLC
Short TermMid-TermLong Term
TrendsBullishBullishBullish
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus HOLD
Number of Analysts 9
Last Close Price 31,91 $
Average target price 26,50 $
Spread / Average Target -17,0%
EPS Revisions
Managers and Directors
Richard F. Pops Chairman & Chief Executive Officer
Iain Michael Brown Senior VP, Chief Financial & Accounting Officer
Craig C. Hopkinson Chief Medical Officer & EVP-Research & Development
Thomas Harvey Chief Information Officer & Senior VP-IT
Sondra Smyrnios Senior Vice President-Clinical Operations
Sector and Competitors
1st jan.Capi. (M$)
ALKERMES PLC59.95%5 148
MODERNA, INC.335.15%177 895
LONZA GROUP AG33.16%61 006
IQVIA HOLDINGS INC.46.38%49 771
CELLTRION, INC.-20.75%31 824
SEAGEN INC.-5.09%30 776