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8-K - Emergent BioSolutions Inc.form8-k-02-22-2018.htm
                                                                   EXHIBIT 99
  

EMERGENT BIOSOLUTIONS REPORTS FOURTH QUARTER AND TWELVE MONTHS 2017 FINANCIAL RESULTS

-
Reaffirms full year 2018 forecast and 2020 goals
-
Revises 1Q 2018 forecast

GAITHERSBURG, Md., February 22, 2018—Emergent BioSolutions Inc. (NYSE: EBS) reported financial results for the quarter and twelve months ended December 31, 2017.

2017 FINANCIAL HIGHLIGHTS
 
(in millions)
 
4Q 2017
(unaudited)
   
4Q 2016 (1)
(unaudited)
 
Total Revenues
 
$
193.8
   
$
151.7
 
Net Income
 
$
33.9
   
$
32.3
 
Adjusted Net Income (2)
 
$
37.8
   
$
36.6
 
EBITDA (1)
 
$
65.2
   
$
61.3
 
 
(in millions)
 
Full Year 2017
(unaudited)
   
Full Year 2016 (1)
 
Total Revenues
 
$
560.9
   
$
488.8
 
Net Income
 
$
82.6
   
$
62.5
 
Adjusted Net Income (2)
 
$
95.7
   
$
77.5
 
EBITDA (1)
 
$
166.0
   
$
141.7
 

(1)
Financial results for 4Q 2016 and Full Year 2016 are presented on a continuing operations basis.
(2)
See "Reconciliation of Net Income to Adjusted Net Income and EBITDA" for a definition of terms and a reconciliation table.

4Q 2017 BUSINESS ACCOMPLISHMENTS
Acquisitions
·
Completed the acquisition of Sanofi's ACAM2000® business, including ACAM2000 (Smallpox (Vaccinia) Vaccine, Live), the only smallpox vaccine licensed by the U.S. Food and Drug Administration (FDA), related manufacturing facilities and employees, and an existing 10-year, $425 million contract with the Centers for Disease Control and Prevention (CDC) with a remaining value at acquisition of up to approximately $160 million for deliveries of ACAM2000 to the Strategic National Stockpile (SNS)
·
Completed the acquisition of Raxibacumab, an FDA-approved anthrax monoclonal antibody, from GSK and assumed responsibility for a multi-year contract with the Biomedical Advanced Research and Development Authority (BARDA), with a remaining value at acquisition of up to approximately $130 million, to supply Raxibacumab to the SNS
Procurement Contracts
·
Awarded a contract valued at up to approximately $25 million by the U.S. Department of State to supply Trobigard™(3) (Atropine Sulfate [2mg]/Obidoxime Chloride [220mg]) auto-injector, a drug and device combination product for emergency use outside of the U.S. in the event of nerve agent or organophosphate poisoning
·
Awarded a contract by the Department of National Defence, valued at approximately $8 million, to deliver Anthrasil® (Anthrax Immune Globulin Intravenous [human]) to the Canadian government
Capital Structure
·
Converted approximately $239.4 million, or 95.8%, of the $250 million 2.875% Convertible Senior Notes due 2021 (the Notes) for approximately 8.5 million shares of the company's common stock by holders of the Notes.
·
Repurchased 788,894 shares of its common stock in the fourth quarter of 2017 under a board-approved share repurchase program

(3) Trobigard is not currently approved or cleared by the U.S. Food and Drug Administration or any similar regulatory body, and is only distributed to authorized government buyers for use outside the U.S. This product is not distributed in the U.S.

2017 FINANCIAL PERFORMANCE

(I) Quarter Ended December 31, 2017 (Unaudited)

Revenues

Total Revenues
For Q4 2017, total revenues were $193.8 million, an increase of 28% as compared to 2016. The increase is primarily driven by increased product sales of $74.1 million mainly due to a $63.2 million increase in BioThrax sales as well as sales of products acquired in Q4 2017, partially offset by a $31.6 million reduction in contracts and grants revenue.

Product Sales
For Q4 2017, product sales were $161.6 million, an increase of 85% as compared to 2016. The increase is principally attributable to a $63.2 million increase in BioThrax® (Anthrax Vaccine Adsorbed) sales as well as a $10.9 million increase primarily due to sales of products acquired in Q4 2017.
 
 
Three Months Ended
December 31,
 
(in millions)
(unaudited)
 
2017
   
2016
   
% Change
 
Product Sales
 
BioThrax®
 
$
107.0
   
$
43.8
     
145
%
Other
   
54.6
     
43.7
     
25
%
Total Product Sales
 
$
161.6
   
$
87.5
     
85
%

Contract Manufacturing
For Q4 2017, revenue from the Company's contract manufacturing operations was $16.2 million, a decrease of 3% as compared to 2016.

Contracts and Grants
For Q4 2017, contracts and grants revenue was $15.9 million, a decrease of 66% as compared to 2016. The decrease primarily reflects a reduction in revenue associated with the successful completion of multiple U.S. government contracts as well as reduced R&D activities related to certain ongoing funded development programs.

Operating Expenses

Cost of Product Sales and Contract Manufacturing
For Q4 2017, cost of product sales and contract manufacturing was $70.3 million, an increase of 84% as compared to 2016. The increase primarily reflects the impact of higher product sales.

Research and Development (Gross and Net)
For Q4 2017, gross R&D expenses were $28.5 million, an increase of 5% as compared to 2016. The increase primarily reflects increased contract development services performed for NuThraxTM and the EV-035 series of molecules, offset by reduced services related to the task orders performed by the Center for Innovation in Advanced Development and Manufacturing (CIADM).

For Q4 2017, net R&D expense (calculated as gross research and development expenses less contracts and grants revenue) was $12.6 million. For Q4 2016, contracts and grants revenue exceeded gross R&D expense, resulting in a net contribution from funded development programs of $20.4 million.

 
Three Months Ended
December 31,
 
(in millions)
(unaudited)
 
2017
   
2016
   
% Change
 
Research and Development Expenses
 
$
28.5
   
$
27.1
     
5
%
Adjustments:
 
-  Contracts and grants revenue
 
$
15.9
   
$
47.5
     
(66
%)
Net Research and Development Expenses (Income)
 
$
12.6
   
$
(20.4
)
   
--
 

Selling, General and Administrative
For Q4 2017, selling, general and administrative expenses were $42.0 million, an increase of 19% as compared to 2016. The increase is attributable to higher compensation expense and professional services fees during the period.

Net Income & Adjusted Net Income
For Q4 2017, net income was $33.9 million, or $0.67 per diluted share, versus $32.3 million, or $0.67 per diluted share, in 2016.

Net income per diluted share is computed using the "if-converted" method prior to November 14, 2017, the date the company terminated conversion rights associated with the company's 2.875% Convertible Senior Notes due 2021 (the Notes). This method requires net income to be adjusted to add back interest expense and amortization of debt issuance cost, both net of tax, associated with the Notes. The following table details the adjustments made in this calculation.

 
Three Months Ended
December 31,
 
(in millions, except per share value)
(unaudited)
 
2017
   
2016
 
Net Income
 
$
33.9
   
$
32.3
 
Adjustments:
 
+  Interest expense, net of tax
   
0.2
     
0.9
 
+  Amortization of debt issuance costs, net of tax
   
0.1
     
0.2
 
Net Income, adjusted ("if converted")
Net Income Per Diluted Share, adjusted ("if converted")
 
$
34.2
0.67
   
$
33.4
0.67
 
Weighted Average Diluted Shares
   
51.0
     
49.6
 

For Q4 2017, adjusted net income, a non-GAAP measure, was $37.8 million, or $0.74 per diluted share, versus $36.6 million, or $0.74 per diluted share, in 2016. See "Reconciliation of Net Income to Adjusted Net Income and EBITDA" for a definition of terms and a reconciliation table.

(II) Year Ended December 31, 2017 (Unaudited)

Revenues

Total Revenues
For the twelve months of 2017, total revenues were $560.9 million, an increase of 15% as compared to 2016. The increase is attributable to significantly increased product sales, notably Other product sales, and contract manufacturing services revenue offset by a decrease in contracts and grants revenue.

Product Sales
For the twelve months of 2017, product sales were $421.5 million, an increase of 42% as compared to 2016. The increase is principally attributable to higher BioThrax sales to the SNS and higher Other product sales, specifically timing of BAT® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)] deliveries to the SNS, international sales of VIGIV and Trobigard and sales of ACAM2000 to the CDC and Raxibacumab to BARDA.
 
 
 
Twelve Months Ended
December 31,
 
(in millions)
 
2017
(unaudited)
   
2016
   
% Change
 
Product Sales
 
BioThrax®
 
$
286.6
   
$
237.0
     
21
%
Other
 
$
134.9
   
$
59.3
     
128
%
Total Product Sales
 
$
421.5
   
$
296.3
     
42
%

Contract Manufacturing
For the twelve months of 2017, revenue from the Company's contract manufacturing operations was $68.9 million, an increase of 40% as compared to 2016. The increase primarily reflects an increase in fill/finish and manufacturing services to commercial entities.

Contracts and Grants
For the twelve months of 2017, contracts and grants revenue was $70.4 million, a decrease of 51% as compared to 2016. The decrease primarily reflects a reduction in revenue associated with the successful completion of multiple U.S. government contracts as well as reduced R&D activities related to certain ongoing funded development programs.

Operating Expenses

Cost of Product Sales and Contract Manufacturing
For the twelve months of 2017, cost of product sales and contract manufacturing was $195.7 million, an increase of 49% as compared to 2016. The increase primarily reflects the impact of higher product sales and increased costs associated with the expansion of our contract manufacturing business.

Research and Development (Gross and Net)
For the twelve months of 2017, gross R&D expenses were $97.4 million, a decrease of 10% as compared to 2016. The decrease primarily reflects lower contract development services costs associated with reduced contract development services performed during the period.

For the twelve months of 2017, net R&D expense (calculated as gross research and development expenses less contracts and grants revenue) was $27.0 million. For the twelve months of 2016, contracts and grants revenue exceeded gross R&D expense, resulting in a net contribution from funded development programs of $35.1 million.

 
Twelve Months Ended
December 31,
 
(in millions)
 
2017
(unaudited)
   
2016
   
% Change
 
Research and Development Expenses
 
$
97.4
   
$
108.3
     
(10
%)
Adjustments:
 
-  Contracts and grants revenue
 
$
70.4
   
$
143.4
     
(51
%)
Net Research and Development Expenses (Income)
 
$
27.0
   
$
(35.1
)
   
--
 

Selling, General and Administrative
For the twelve months of 2017, selling, general and administrative expenses were $143.5 million, unchanged as compared to 2016.

Net Income & Adjusted Net Income
For the twelve months of 2017, net income was $82.6 million, or $1.71 per diluted share, versus $62.5 million, or $1.35 per diluted share, in 2016.

Net income per diluted share is computed using the "if-converted" method prior to November 14, 2017, the date the company terminated conversion rights associated with the company's 2.875% Convertible Senior Notes due 2021 (the Notes). This method requires net income to be adjusted to add back interest expense and amortization of debt issuance cost, both net of tax, associated with the Notes. The following table details the adjustments made in this calculation.

 
Twelve Months Ended
December 31,
 
(in millions, except per share value)
 
2017
(unaudited)
   
2016
 
Net Income
 
$
82.6
   
$
62.5
 
Adjustments:
 
+  Interest expense, net of tax
   
2.6
     
3.3
 
+  Amortization of debt issuance costs, net of tax
   
0.7
     
0.8
 
Net Income, adjusted ("if converted")
Net Income Per Diluted Share, adjusted ("if converted")
 
$
85.9
1.71
   
$
66.6
1.35
 
Weighted Average Diluted Shares
   
50.3
     
49.3
 

For the twelve months of 2017, adjusted net income, a non-GAAP measure, was $95.7 million, or $1.90 per diluted share, versus $77.5 million, or $1.57 per diluted share, in 2016. See "Reconciliation of Net Income to Adjusted Net Income and EBITDA" for a definition of terms and a reconciliation table.

2018 FINANCIAL & OPERATIONAL GOALS
2018 Financial Forecast:
·
Total revenue of $715 to $755 million
·
Pre-Tax income of $120 to $140 million
·
Net income of $95 to $110 million
·
Adjusted net income of $110 to $125 million (2)
·
EBITDA of $175 to $190 million (2)

(2)
See "Reconciliation of Net Income to Adjusted Net Income and EBITDA" for a definition of terms and a reconciliation table.

2018 Operational Goals:
·
Advance NuThrax development to enable Emergency Use Authorization filing with the FDA in 2018
·
Complete ACAM2000 deliveries; establish a multi-year follow-on contract with the U.S. government
·
Deliver Raxibacumab doses under current contract; advance tech transfer to the company's CIADM Bayview facility in Baltimore, Maryland
·
Progress pipeline to have at least four product candidates in advanced development
·
Complete an acquisition that generates revenue within 12 months of closing

1Q 2018 Financial Forecast (Revised):
·
Total revenue of $125 to $150 million; previous forecast was $145 to $160 million; the revision primarily reflects the timing of deliveries of BioThrax

2020 FINANCIAL & OPERATIONAL GOALS
The Company is targeting the following 2020 financial and operational goals:
·
Total Revenue:  $1 billion
·
Revenue Mix:  at least 10% of total revenue from ex-US customers
·
Expense Discipline:  Net R&D <15% of net revenue (4); SG&A <25% of total revenue
·
Net Income:  at least 14% of total revenue
·
Product Development Pipeline:  Six products in clinical or advanced development (with at least three dual-market opportunities)

(4) Computed as Total Revenue less Contracts & Grants Revenue.

CONFERENCE CALL AND WEBCAST INFORMATION
Company management will host a conference call at 5:00 pm (Eastern Time) today, February 22, 2018, to discuss these financial results. This conference call can be accessed live by telephone or through Emergent's website:

Live Teleconference Information:
Dial in number: (855) 766-6521
International dial in: (262) 912-6157
Conference ID: 93325042

Live Webcast Information:
Visit edge.media-server.com/m6/p/qhvnyd93 for the live webcast feed.

A replay of the call can be accessed on Emergent's website emergentbiosolutions.com under "Investors."

ABOUT EMERGENT BIOSOLUTIONS INC.
Emergent BioSolutions Inc. is a global life sciences company seeking to protect and enhance life by focusing on providing specialty products for civilian and military populations that address accidental, intentional, and naturally occurring public health threats. Through our work, we envision protecting and enhancing 50 million lives with our products by 2025. Additional information about the company may be found at www.emergentbiosolutions.com. Follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.

SAFE HARBOR STATEMENT
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including, without limitation, our financial guidance, statements regarding the potential opportunities and anticipated financial implications of our acquisitions of the ACAM2000 business from Sanofi Pasteur Biologics, LLC and Raxibacumab from GlaxoSmithKline LLC, and any other statements containing the words "will," "believes," "expects," "anticipates," "intends," "plans," "targets," "forecasts," "estimates" and similar expressions in conjunction with, among other things, discussions of the Company's outlook, financial performance or financial condition, strategic goals, growth strategy, acquisition strategy, product sales, government development or procurement contracts or awards, government appropriations, manufacturing capabilities, product development and delivery timeline, and Emergency Use Authorization (EUA) and the timing of other regulatory approvals or expenditures are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.

There are a number of important factors that could cause the Company's actual results to differ materially from those indicated by such forward-looking statements, including the availability of funding and the exercise of options under our BioThrax and NuThrax contracts; appropriations for the procurement of our products; our ability to secure EUA pre-authorization approval and licensure of NuThrax from the FDA within the anticipated timeframe, if at all; availability of funding for our U.S. government grants and contracts; our ability to identify and acquire or in-license products or product candidates that satisfy our selection criteria; our ability to successfully integrate and develop the products or product candidates, programs, operations and personnel of any entities, businesses or products that we acquire, including our recently completed acquisitions of the ACAM2000 business from Sanofi and Raxibacumab from GSK and the timing and receipt of required FDA approvals for actions contemplated in connection with our integration of these products; whether anticipated synergies and benefits from an acquisition or in-license are realized within expected time periods, if at all; our ability to utilize our manufacturing facilities and expand our capabilities; our ability and the ability of our contractors and suppliers to maintain compliance with Current Good Manufacturing Practices and other regulatory obligations; the results of regulatory inspections; the outcome of the purported class action lawsuit filed against us and possible other future material legal proceedings; our ability to meet operating and financial restrictions placed on us and our subsidiaries that are contained in our senior credit facility; the success of our ongoing and planned development programs; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; and our commercialization, marketing and manufacturing capabilities and strategy. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the Securities and Exchange Commission, when evaluating our forward-looking statements.

###

Investor Contact
Robert Burrows
Vice President, Investor Relations
(o) 240/631-3280; (m) 240/413-1917
burrowsr@ebsi.com
Media Contact
Lynn Kieffer
Vice President, Corporate Communications
(o) 240/631-3391
kiefferl@ebsi.com

FINANCIAL STATEMENTS FOLLOW


Emergent BioSolutions Inc. and Subsidiaries
 
Consolidated Statements of Operations
 
(in thousands, except share and per share data)
 
             
   
Three Months Ended December 31,
 
   
2017
   
2016
 
   
(Unaudited)
 
Revenues:
           
Product sales
 
$
161,641
   
$
87,493
 
Contract manufacturing
   
16,235
     
16,683
 
Contracts and grants
   
15,933
     
47,487
 
Total revenues
   
193,809
     
151,663
 
                 
Operating expenses:
               
Cost of product sales and contract manufacturing
   
70,258
     
38,259
 
Research and development
   
28,498
     
27,117
 
Selling, general and administrative
   
41,976
     
35,358
 
Income from operations
   
53,077
     
50,929
 
                 
Other income (expense):
               
Interest income
   
160
     
289
 
Interest expense
   
(856
)
   
(2,535
)
Other income (expense), net
   
(428
)
   
439
 
Total other expense, net
   
(1,124
)
   
(1,807
)
                 
Income before provision for income taxes
   
51,953
     
49,122
 
Provision for income taxes
   
18,011
     
16,836
 
Net income
 
$
33,942
   
$
32,286
 
                 
Net income per share - basic
 
$
0.77
   
$
0.80
 
Net income per share – diluted (5)
 
$
0.67
   
$
0.67
 
                 
Weighted-average number of shares - basic
   
44,269,276
     
40,519,002
 
Weighted-average number of shares - diluted
   
51,004,378
     
49,572,655
 
                 

(5)
See "Net Income and Adjusted Net Income" within section "(I) Quarter Ended December 31, 2017 and 2016 (Unaudited)" for explanation of adjustments to denominator for per diluted share calculation.
 
Emergent BioSolutions Inc. and Subsidiaries
 
Consolidated Statements of Operations
 
(in thousands, except share and per share data)
 
             
   
Twelve Months Ended December 31,
 
   
2017
   
2016
 
   
(Unaudited)
 
Revenues:
           
Product sales
 
$
421,516
   
$
296,278
 
Contract manufacturing
   
68,935
     
49,138
 
Contracts and grants
   
70,422
     
143,366
 
Total revenues
   
560,873
     
488,782
 
                 
Operating expenses:
               
Cost of product sales and contract manufacturing
   
195,707
     
131,284
 
Research and development
   
97,384
     
108,290
 
Selling, general and administrative
   
143,497
     
143,686
 
Income from operations
   
124,285
     
105,522
 
                 
Other income (expense):
               
Interest income
   
1,753
     
1,053
 
Interest expense
   
(6,590
)
   
(7,617
)
Other income (expense), net
   
(815
)
   
263
 
Total other expense, net
   
(5,652
)
   
(6,301
)
                 
Income from continuing operations before provision for income taxes
   
118,633
     
99,221
 
Provision for income taxes
   
36,039
     
36,697
 
Net income from continuing operations
   
82,594
     
62,524
 
Net loss from discontinued operations
   
-
     
(10,748
)
Net income
 
$
82,594
   
$
51,776
 
                 
Net income per share from continuing operations - basic
 
$
1.98
   
$
1.56
 
Net loss per share from discontinued operations - basic
   
-
     
(0.27
)
Net income per share - basic
 
$
1.98
   
$
1.29
 
                 
Net income per share from continuing operations - diluted
 
$
1.71
   
$
1.35
 
Net loss per share from discontinued operations - diluted
   
-
     
(0.22
)
Net income per share - diluted (5)
 
$
1.71
   
$
1.13
 
                 
Weighted-average number of shares - basic
   
41,816,431
     
40,184,159
 
Weighted-average number of shares - diluted
   
50,327,937
     
49,335,112
 
                 

(5)
See "Net Income and Adjusted Net Income" within section "(II) Year Ended December 31, 2017
(Unaudited)" for explanation of adjustments to denominator for per diluted share calculation.

 
Emergent BioSolutions Inc. and Subsidiaries
 
Consolidated Balance Sheets
 
(in thousands, except share and per share data)
 
   
December 31, 2017
   
December 31, 2016
 
ASSETS
 
(Unaudited)
       
Current assets:
           
Cash and cash equivalents
 
$
178,292
   
$
271,513
 
Restricted cash
   
1,043
     
-
 
Accounts receivable, net
   
143,653
     
138,478
 
Inventories
   
142,812
     
74,002
 
Income tax receivable, net
   
2,432
     
9,996
 
Prepaid expenses and other current assets
   
17,157
     
16,229
 
Total current assets
   
485,389
     
510,218
 
Property, plant and equipment, net
   
407,210
     
376,448
 
Intangible assets, net
   
119,597
     
33,865
 
Goodwill
   
49,130
     
41,001
 
Deferred tax assets, long-term, net
   
2,834
     
6,096
 
Other assets
   
6,046
     
2,483
 
Total assets
 
$
1,070,206
   
$
970,111
 
LIABILITIES AND STOCKHOLDERS' EQUITY
               
Current liabilities:
               
Accounts payable
 
$
41,751
   
$
34,649
 
Accrued expenses and other current liabilities
   
4,831
     
6,368
 
Accrued compensation
   
37,882
     
34,537
 
Notes payable
   
-
     
20,000
 
Contingent consideration, current portion
   
2,372
     
3,266
 
Deferred revenue, current portion
   
13,232
     
7,036
 
Total current liabilities
   
100,068
     
105,856
 
Contingent consideration, net of current portion
   
9,902
     
9,919
 
Long-term indebtedness
   
13,457
     
248,094
 
Income taxes payable, net of current
   
12,500
     
-
 
Deferred revenue, net of current portion
   
17,259
     
8,433
 
Other liabilities
   
4,675
     
1,604
 
Total liabilities
   
157,861
     
373,906
 
Stockholders' equity:
               
Preferred stock, $0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding at both December 31, 2017 and December 31, 2016
   
-
     
-
 
Common stock, $0.001 par value; 200,000,000 shares authorized, 50,619,808 shares issued and 49,405,365 shares outstanding at December 31, 2017; 40,996,890 shares issued and 40,574,060 shares outstanding at December 31, 2016
   
50
     
41
 
Treasury stock, at cost, 1,214,443 and 422,830 common shares at December 31, 2017 and December 31, 2016, respectively
   
(39,497
)
   
(6,420
)
Additional paid-in capital
   
618,416
     
352,435
 
Accumulated other comprehensive loss
   
(3,698
)
   
(4,331
)
Retained earnings
   
337,074
     
254,480
 
Total stockholders' equity
   
912,345
     
596,205
 
Total liabilities and stockholders' equity
 
$
1,070,206
   
$
970,111
 
                 

RECONCILIATION OF NET INCOME TO ADJUSTED NET INCOME AND EBITDA
This press release contains two financial measures (Adjusted Net Income and EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization)) that are considered "non-GAAP" financial measures under applicable Securities and Exchange Commission rules and regulations. These non-GAAP financial measures should be considered supplemental to and not a substitute for financial information prepared in accordance with generally accepted accounting principles. The Company's definition of these non-GAAP measures may differ from similarly titled measures used by others. Adjusted Net Income adjusts for specified items that can be highly variable or difficult to predict, or reflect the non-cash impact of charges resulting from purchase accounting. EBITDA reflects net income excluding the impact of depreciation, amortization, interest expense and provision for income taxes. The Company views these non-GAAP financial measures as a means to facilitate management's financial and operational decision-making, including evaluation of the Company's historical operating results and comparison to competitors' operating results. These non-GAAP financial measures reflect an additional way of viewing aspects of the Company's operations that, when viewed with GAAP results and the reconciliations to the corresponding GAAP financial measure, may provide a more complete understanding of factors and trends affecting the Company's business.

The determination of the amounts that are excluded from these non-GAAP financial measures are a matter of management judgment and depend upon, among other factors, the nature of the underlying expense or income amounts. Because non-GAAP financial measures exclude the effect of items that will increase or decrease the Company's reported results of operations, management strongly encourages investors to review the Company's consolidated financial statements and publicly filed reports in their entirety.

Reconciliation of Net Income to Adjusted Net Income (Unaudited)

 
Three Months Ended
December 31,
 
(in millions, except per share value)
 
2017
   
2016
   
Source
 
Net Income
 
$
33.9
   
$
32.3
     
N/A
 
Adjustments:
 
+  Acquisition-related costs (transaction & integration)
   
1.5
     
1.0
   
SG&A
 
+  Non-cash amortization charges
   
4.1
     
1.9
   
COGS, SG&A, Other Income
 
+  Exit and disposal costs
   
--
     
2.6
   
SG&A
 
+  Impact of purchase accounting on inventory step-up
   
0.4
     
1.1
   
SG&A
 
  Tax effect
   
(2.1
)
   
(2.3
)
   
N/A
 
Total Adjustments:
   
3.9
     
4.3
     
N/A
 
Adjusted Net Income
Adjusted Net Income Per Diluted Share
 
$
37.8
0.74
   
$
36.6
0.74
     
N/A
 
 
 
 
Twelve Months Ended
December 31,
 
(in millions, except per share value)
 
2017
   
2016
   
Source
 
Net Income
 
$
82.6
   
$
62.5
     
N/A
 
Adjustments:
 
+  Acquisition-related costs (transaction & integration)
   
5.6
     
1.7
   
SG&A
 
+  Non-cash amortization charges
   
10.3
     
8.4
   
COGS, SG&A, Other Income
 
+  Exit and disposal costs
   
1.5
     
11.7
   
SG&A
 
+  Impact of purchase accounting on inventory step-up
   
2.6
     
1.1
   
SG&A
 
  Tax effect
   
(7.0
)
   
(8.0
)
   
N/A
 
Total Adjustments:
   
13.1
     
15.0
     
N/A
 
Adjusted Net Income
Adjusted Net Income Per Diluted Share
 
$
95.7
1.90
   
$
77.5
1.57
     
N/A
 

Reconciliation of Net Income to EBITDA (Unaudited)

 
Three Months Ended
December 31,
 
(in millions, except per share value)
 
2017
   
2016
 
Net Income
 
$
33.9
   
$
32.3
 
Adjustments:
 
+  Depreciation & Amortization
   
12.4
     
9.7
 
+  Provision for Income Taxes
   
18.0
     
16.8
 
+  Total Interest Expense
   
0.9
     
2.5
 
Total Adjustments
   
31.3
     
29.0
 
EBITDA
EBITDA per Diluted Share
 
$
65.2
1.28
   
$
61.3
1.24
 

 
Twelve Months Ended
December 31,
 
(in millions, except per share value)
 
2017
   
2016
 
Net Income
 
$
82.6
     
62.5
 
Adjustments:
 
+  Depreciation & Amortization
   
40.8
     
34.9
 
+  Provision for Income Taxes
   
36.0
     
36.7
 
+  Total Interest Expense
   
6.6
     
7.6
 
Total Adjustments
   
83.4
     
79.2
 
EBITDA
EBITDA per Diluted Share
 
$
166.0
3.30
   
$
141.7
2.87
 

RECONCILIATION OF STATEMENT OF OPERATIONS
The following table provides a reconciliation of the Company's Statement of Operations for the Twelve Months Ended December 31, 2016 on a continuing operations basis to that on a combined basis, which takes into account the impact of the Aptevo-related discontinued operations.

(in millions)
 
   
Twelve Months Ended December 31, 2016
 
   
Continuing Operations
   
Discontinuing Operations
   
Combined
 
Revenues:
     
Product sales
 
$
296.3
   
$
21.2
   
$
317.5
 
Contract manufacturing
   
49.1
     
-
     
49.1
 
Contracts and grants
   
143.4
     
0.2
     
143.6
 
Total revenues
   
488.8
     
21.4
     
510.2
 
                         
Operating expenses:
                       
Cost of product sales and contract manufacturing
   
131.3
     
11.6
     
142.9
 
Research and development
   
108.3
     
18.0
     
126.3
 
Selling, general and administrative
   
143.7
     
23.8
     
167.5
 
Income (loss) from operations
   
105.5
     
(32.0
)
   
73.5
 
                         
Other income (expense):
                       
Interest income
   
1.1
     
-
     
1.1
 
Interest expense
   
(7.6
)
   
-
     
(7.6
)
Other expense, net
   
0.2
     
(0.0
)
   
0.2
 
Total other expense, net
   
(6.3
)
   
(0.0
)
   
(6.3
)
                         
Income (loss) before provision for (benefit) from income taxes
   
99.2
     
(32.0
)
   
67.2
 
Provision for (benefit from) income taxes
   
36.7
     
(21.3
)
   
15.4
 
Net income (loss)
 
$
62.5
   
$
(10.7
)
 
$
51.8