Emergent BioSolutions Reports Second Quarter and Six Months 2016 Financial Results

Gaithersburg, Maryland, UNITED STATES


GAITHERSBURG, Md., Aug. 04, 2016 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) reported financial results for the quarter and six months ended June 30, 2016.

FINANCIAL HIGHLIGHTS

  • Total revenues: Q2 2016 of $101.5 million; six months 2016 of $212.5 million
  • GAAP net loss: Q2 2016 of $(10.9) million, or $(0.27) per diluted share; six months 2016 of $(7.0) million, or $(0.17) per diluted share
  • Adjusted net income/loss: Q2 2016 net loss of $(7.1) million, or $(0.18) per diluted share; six months 2016 net income of $0.3 million, or $0.01 per diluted share
  • EBITDA: Q2 2016 of $(4.8) million, or $(0.12) per diluted share; six months of $12.4 million, or $0.31 per diluted share
  • Adjusted EBITDA: Q2 2016 of $(2.2) million, or $(0.05) per diluted share; six months 2016 of $17.3 million, or $0.43 per diluted share

Q2 2016 & RECENT BUSINESS ACCOMPLISHMENTS

  • Spin-off of Aptevo Therapeutics completed
  • Repurchase program for up to $50 million of the Company’s common stock authorized
  • Building 55 milestones achieved towards Food and Drug Administration (FDA) licensure
    • Supplemental Biologics License Application accepted
    • Pre-approval inspection completed
    • PDUFA date of August 15, 2016 established
  • BioThrax® (Anthrax Vaccine Adsorbed) granted Orphan Drug status by the FDA for post-exposure prophylaxis (PEP) of anthrax disease
  • Centers for Disease Control and Prevention (CDC) confirmed intent to award a follow-on procurement contract for BioThrax® (Anthrax Vaccine Adsorbed) by September 23, 2016
  • U.S. Department of Health and Human Services (HHS) issued a request for proposal seeking a next generation anthrax vaccine; today the company submitted a response proposing its product candidate NuThrax™ (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant)
  • Task order for up to $21.9 million to develop and manufacture three cGMP lots of a Zika vaccine received from the Biomedical Advanced Research and Development Authority

2016 OUTLOOK

The Company will continue to temporarily postpone its financial guidance for 2016 until further clarity is reached on the following U.S. government contracts and solicitations:

  • Current BioThrax procurement contract: By letter dated April 26, 2016 the CDC indicated that it anticipated procuring less than the total remaining doses of BioThrax under the existing procurement contract and did not quantify the number of doses anticipated to be procured.
  • Follow-on BioThrax procurement contract: On June 21, 2016, HHS issued a Sole Source Notification indicating its intention by September 23, 2016 to award to the Company a follow-on contract to procure 29.4 million doses of BioThrax with a period of performance of five years. The terms of the contract, including the price per dose and the timing of deliveries, remain subject to contract negotiation.
  • Notice of Solicitation for Next Generation Anthrax Vaccine: On June 21, 2016, HHS issued a request for proposal seeking a next generation anthrax vaccine for post-exposure prophylaxis of anthrax disease with the ability to confer protection in one or two doses and meeting additional specific criteria relating to safety, efficacy and manufacturing.

2016 FINANCIAL PERFORMANCE

(I) Quarter Ended June 30, 2016 (unaudited)

Revenues

Product Sales
For Q2 2016, product sales were $58.5 million, a decrease of 29% as compared to 2015. The decrease in BioThrax sales was primarily due to a reduction in shipments to the CDC consistent with the April 26, 2016 letter from CDC that indicated that it anticipated procuring less than the total remaining doses of BioThrax under the existing procurement contract. The increase in Other Biodefense sales was primarily due to VIGIV sales to the Strategic National Stockpile (SNS). The increase in Aptevo sales was mainly due to increased sales of IXINITY (received FDA licensure and launched in Q2 2015).


(in millions)
Three Months Ended
June 30,
 2016  2015 % Change
Product Sales
BioThrax®$40.0 $72.2  (45)%
Other Biodefense$8.3 $2.8  192%
Total Biodefense$48.3 $75.1  (36)%
Total Aptevo Products $10.2 $6.9  47%
Total Product Sales$58.5 $82.0  (29)%


Contract Manufacturing

For Q2 2016, revenue from the Company’s contract manufacturing operations was $10.2 million, an increase of 15% as compared to 2015. The increase is due primarily to services related to plasma collection and related testing activities.

Contracts, Grants and Collaborations
For Q2 2016, contracts, grants and collaborations revenue was $32.8 million, a decrease of 7% as compared to 2015.

Operating Expenses

Cost of Product Sales and Contract Manufacturing
For Q2 2016, cost of product sales and contract manufacturing was $35.6 million, an increase of 31% as compared to 2015, attributable to an increase in rejected BioThrax work-in-process material, as well as increased Other Biodefense and Aptevo product sales.

Research and Development
For Q2 2016, gross research and development (R&D) expenses were $35.3 million, a decrease of 14% as compared to 2015. The decrease primarily reflects lower contract service costs.

For Q2 2016, net R&D expenses were $2.5 million, a decrease of 55% as compared to 2015. Net R&D expenses, which are more representative of the Company’s actual out-of-pocket investment in product development, are calculated as gross research and development expenses less contracts, grants and collaboration revenues.

(in millions)Three Months Ended
June 30,
 2016  2015 % Change
Research and Development Expenses (Gross)$35.3 $40.9  (14)%
Adjustments:
-  Contracts, grants and collaborations revenues$32.8 $35.2  (7)%
Net Research and Development Expenses$2.5 $5.7  (55)%


Selling, General and Administrative

For Q2 2016, selling, general and administrative expenses were $44.1 million, an increase of 21% as compared to 2015. This increase includes costs associated with the Aptevo spin-off along with increased professional services to support our strategic growth initiatives, higher IXINITY selling costs, and information technology investments.

Net Income/(Loss)
For Q2 2016, GAAP net loss was $(10.9) million, or $(0.27) per diluted share, versus GAAP net income of $14.1 million, or $0.32 per diluted share, in 2015.

(II) Six Months Ended June 30, 2016 (unaudited)

Revenues

Product Sales
For the six months of 2016, product sales were $130.3 million, an increase of 30% as compared to 2015. The increase in BioThrax sales was primarily due to the suspension of shipments to the CDC in Q1 2015 following the discovery of foreign particles in a limited number of vials in two manufactured lots of BioThrax, resulting in reduced sales volume in the first half of 2015. The decrease in Other Biodefense sales was primarily due to lower RSDL shipments. The increase in Aptevo sales was mainly due to increased sales of IXINITY.


(in millions)
Six Months Ended
June 30,
 2016  2015 % Change
Product Sales
BioThrax®$99.1 $72.2  37%
Other Biodefense$13.0 $14.8  (12)%
Total Biodefense$112.1 $87.1  29%
Total Aptevo Products $18.1 $13.3  37%
Total Product Sales$130.3 $100.3  30%


Contract Manufacturing

For the six months of 2016, revenue from the Company’s contract manufacturing operations was $17.7 million, a decrease of 16% as compared to 2015. The change is primarily due to a decrease of $3.8 million from services related to the production of an MVA Ebola vaccine in 2015.

Contracts, Grants and Collaborations
For the six months of 2016, contracts, grants and collaborations revenue was $64.5 million, a decrease of 6% as compared to 2015.

Operating Expenses

Cost of Product Sales and Contract Manufacturing
For the six months of 2016, cost of product sales and contract manufacturing was $64.1 million, an increase of 39% as compared to 2015, primarily attributable to the 37% increase in BioThrax product sales.

Research and Development
For the six months of 2016, gross research and development (R&D) expenses were $69.5 million, a decrease of 13% as compared to 2015. The decrease primarily reflects lower contract service costs.

For the six months of 2016, net R&D expenses were $5.0 million, a decrease of 56% as compared to 2015.

(in millions)Six Months Ended
June 30,
 2016  2015 % Change
Research and Development Expenses (Gross)$69.5 $79.6  (13)%
Adjustments:
-  Contracts, grants and collaborations revenues$64.5 $68.3  (6)%
Net Research and Development Expenses$5.0 $11.3  (56)%


Selling, General and Administrative
For the six months of 2016, selling, general and administrative expenses were $83.9 million, an increase of 18% as compared to 2015. This increase includes costs associated with the Aptevo spin-off along with increased professional services to support our strategic growth initiatives, additional selling effort for IXINITY, and information technology investments.

Net Loss
For the six months of 2016, GAAP net loss was $(7.0) million, or $(0.17) per diluted share, versus GAAP net loss of $(7.4) million, or $(0.19) per diluted share, in 2015.

(III) RECONCILIATION OF GAAP NET INCOME/(LOSS) TO ADJUSTED NET INCOME/(LOSS), EBITDA AND ADJUSTED EBITDA

This press release contains three financial measures (Adjusted Net Income/(Loss), EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization), and adjusted EBITDA) 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/(Loss) 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. Adjusted EBITDA also excludes specified items that can be highly variable and the non-cash impact of certain purchase accounting adjustments. 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 GAAP Net Income/(Loss) to Adjusted Net Income/(Loss)

The following table provides a reconciliation of GAAP Net Income/(Loss) to Adjusted Net Income/(Loss) for the three month periods as indicated.

(in millions, except per share value)Three Months Ended June 30,
 2016  2015 Source
GAAP Net Income/(Loss)$(10.9)$14.1 NA
Adjustments:
+  Spin-off and acquisition-related costs (transaction & integration) 2.6  1.4 SG&A
+  Non-cash amortization charges  2.8  2.8 COGS, SG&A,
Other Income
Tax effect  (1.6) (1.3)NA
Total Adjustments 3.8  2.9 NA
Adjusted Net Income/(Loss)
Adjusted Net Income/(Loss) per Diluted Share

$
$
(7.1
(0.18
)
)
$
$

17.0
0.36
 NA

The following table provides a reconciliation of GAAP Net Loss to Adjusted Net Income/(Loss) for the six month periods as indicated.

(in millions, except per share value)Six Months Ended June 30,
 2016  2015 Source
GAAP Net Loss$(7.0)$(7.4)NA
Adjustments:
+  Spin-off and acquisition-related costs (transaction & integration)  4.9  2.5 SG&A
+  Non-cash amortization charges  5.5  5.3 COGS, SG&A,
Other Income
+  Impact of purchase accounting on inventory step-up  -   0.1 SG&A
Tax effect  (3.1) (2.4)NA
Total Adjustments 7.3  5.6 NA
Adjusted Net Income/(Loss)
Adjusted Net Income/(Loss) per Diluted Share
$
$
0.3
0.01
 $
$
(1.8
(0.05
)
)
NA

Reconciliation of GAAP Net Income/(Loss) to EBITDA and Adjusted EBITDA

The following table provides a reconciliation of GAAP Net Income/(Loss) to EBITDA and Adjusted EBITDA for the three month periods as indicated.

(in millions, except per share value)Three Months Ended June 30,
 2016  2015 
GAAP Net Income/(Loss)$(10.9)$14.1 
Adjustments:
+  Depreciation & Amortization 8.5  8.4 
+  Provision For/(Benefit From) Income Taxes (3.9) 5.5 
+  Total Interest Expense 1.5  1.6 
Total Adjustments 6.1  15.5 
EBITDA
EBITDA per Diluted Share
$
$
(4.8
(0.12
)
)
$
$
29.6
0.62
 
Additional Adjustments:
+  Spin-off and acquisition-related costs (transaction & integration) 2.6  1.4 
Total Additional Adjustments 2.6  1.4 
Adjusted EBITDA
Adjusted EBITDA per Diluted Share
$
$
(2.2
(0.05
)
)
$
$
31.0
0.65
 

The following table provides a reconciliation of GAAP Net Loss to EBITDA and Adjusted EBITDA for the six month periods as indicated.

(in millions, except per share value)Six Months Ended June 30,
 2016  2015 
GAAP Net Loss$(7.0)$(7.4)
Adjustments:
+  Depreciation & Amortization 17.0  16.5 
+  Provision For/(Benefit From) Income Taxes (0.6) (2.8)
+  Total Interest Expense 3.0  3.3 
Total Adjustments 19.4  17.0 
EBITDA
EBITDA per Diluted Share
$
$
12.4
0.31
 $
$
9.6
0.25
 
Additional Adjustments:
+  Spin-off and acquisition-related costs (transaction & integration) 4.9  2.5 
+  Impact of purchase accounting on inventory step-up  -  0.1 
Total Additional Adjustments 4.9  2.6 
Adjusted EBITDA
Adjusted EBITDA per Diluted Share
$
$
17.3
0.43
 $
$
12.2
0.32
 


CONFERENCE CALL AND WEBCAST INFORMATION

Company management will host a conference call at 5:00 pm (Eastern Time) today, August 4, 2016, 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
Passcode: 29444249

Webcast Information:
Live webcast feed can be accessed using this link: http://edge.media-server.com/m/p/7wsyx2ie/lan/en.
A replay of the call can be accessed on Emergent’s website www.emergentbiosolutions.com under “Investors.”

ABOUT EMERGENT BIOSOLUTIONS INC.

Emergent BioSolutions is a global specialty biopharmaceutical company dedicated to one simple mission—to protect and enhance life. We develop, manufacture, and deliver a portfolio of medical countermeasures for biological and chemical threats as well as emerging infectious diseases. 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 @emergentbiosolu.

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, , any statements containing the words "believes", "expects", "anticipates", "intends", "plans", "forecasts", "estimates" and similar expressions in conjunction with, among other things, discussions of the Company’s outlook, financial performance or financial condition, growth strategy, product sales, potential government procurement contracts or awards, manufacturing capabilities, product development, 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 ability to obtain a new procurement contract for BioThrax; the ability to obtain a development and procurement contract under the request for proposal for a next generation anthrax vaccine; appropriations for procurement of BioThrax and a next generation anthrax vaccine; our plans to pursue label expansions and improvements for BioThrax; availability of funding for our US government grants and contracts; whether the operational, marketing and strategic benefits of the spin-off of our biosciences business can be achieved and the timing of any such benefits; our ability to identify and acquire or in-license products or late-stage product candidates that satisfy our selection criteria; whether anticipated synergies and benefits from an acquisition or in-license are realized within expected time periods or at all; our ability to achieve FDA licensure of Building 55; our ability to expand our manufacturing facilities and capabilities; our ability and the ability of our contractors and suppliers to maintain compliance with cGMP and other regulatory obligations; the results of regulatory inspections; the outcome of the purported class action lawsuit recently 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 rate and degree of market acceptance and clinical utility of our products; 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 SEC, when evaluating our forward-looking statements.

FINANCIAL STATEMENTS FOLLOW


Emergent BioSolutions Inc. and Subsidiaries
Consolidated Balance Sheets
(in thousands, except share and per share data)
     
 June 30, 2016December 31, 2015
ASSETS (Unaudited)  
Current assets:    
Cash and cash equivalents$   333,395 $   312,795 
Accounts receivable, net    66,749     120,767 
Inventories    96,674     76,936 
Income tax receivable, net    9,184     6,573 
Prepaid expenses and other current assets    22,045     20,339 
Total current assets    528,047     537,410 
Property, plant and equipment, net    359,034     331,856 
In-process research and development    41,800     42,501 
Intangible assets, net    52,645     57,375 
Goodwill    54,902     54,902 
Deferred tax assets, long-term, net    18,192     11,286 
Other assets    1,846     2,154 
Total assets$   1,056,466 $   1,037,484 
LIABILITIES AND STOCKHOLDERS' EQUITY    
Current liabilities:    
Accounts payable$   58,974 $   45,966 
Accrued expenses and other current liabilities    2,482     6,229 
Accrued compensation    29,778     34,683 
Contingent consideration, current portion    2,983     2,553 
Provisions for chargebacks    2,512     2,238 
Deferred revenue, current portion    7,129     7,942 
Total current liabilities    103,858     99,611 
Contingent consideration, net of current portion    22,580     23,046 
Long-term indebtedness    247,393     246,892 
Deferred revenue, net of current portion    8,410     6,590 
Other liabilities    1,553     1,328 
Total liabilities    383,794     377,467 
     
Stockholders’ equity:    
Preferred stock, $0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding
at both June 30, 2016 and December 31, 2015
    -     - 
Common stock, $0.001 par value; 200,000,000 and 100,000,000 shares authorized as of June 30, 2016
and December 31, 2015, respectively. 40,852,511 shares issued and 40,429,681 shares outstanding at
June 30, 2016; 39,829,408 shares issued and 39,406,578 shares outstanding at December 31, 2015
    41     40 
Treasury stock, at cost, 422,830 common shares at both June 30, 2016 and December 31, 2015    (6,420)    (6,420)
Additional paid-in capital    337,947     317,971 
Accumulated other comprehensive loss    (3,080)    (2,713)
Retained earnings    344,184     351,139 
Total stockholders’ equity    672,672     660,017 
Total liabilities and stockholders’ equity$   1,056,466 $   1,037,484 



Emergent BioSolutions Inc. and Subsidiaries
Consolidated Statements of Operations
(in thousands, except share and per share data)
     
 Three Months Ended June 30,
 20162015
 (Unaudited)
Revenues:    
Product sales$   58,546 $   82,023 
Contract manufacturing    10,156     8,859 
Contracts, grants and collaborations    32,785     35,230 
Total revenues    101,487     126,112 
     
Operating expense:    
Cost of product sales and contract manufacturing    35,612     27,266 
Research and development    35,347     40,941 
Selling, general and administrative    44,148     36,453 
Income (loss) from operations    (13,620)    21,452 
     
Other income (expense):    
Interest income    220     273 
Interest expense    (1,509)    (1,628)
Other income, net    17     (497)
Total other expense, net    (1,272)    (1,852)
     
Income (loss) before provision for (benefit from) income taxes     (14,892)    19,600 
Provision for (benefit from) income taxes    3,945     5,500 
Net income (loss)$   (10,947)$   14,100 
     
Net income (loss) per share - basic$   (0.27)$   0.37 
Net income (loss) per share - diluted$   (0.27)$   0.32 
     
Weighted-average number of shares - basic    40,202,821     38,480,754 
Weighted-average number of shares - diluted    40,202,821     47,410,413 



Emergent BioSolutions Inc. and Subsidiaries
Consolidated Statements of Operations
(in thousands, except share and per share data)
     
 Six Months Ended June 30,
 20162015
 (Unaudited)
Revenues:    
Product sales$   130,252 $   100,314 
Contract manufacturing    17,743     21,102 
Contracts, grants and collaborations    64,494     68,329 
Total revenues    212,489     189,745 
     
Operating expense:    
Cost of product sales and contract manufacturing    64,115     46,014 
Research and development    69,501     79,643 
Selling, general and administrative    83,932     70,946 
Loss from operations    (5,059)    (6,858)
     
Other income (expense):    
Interest income    406     355 
Interest expense    (3,033)    (3,288)
Other income (expense), net    133     (397)
Total other expense, net    (2,494)    (3,330)
     
Loss before provision for income taxes     (7,552)    (10,188)
Provision for income taxes    597     2,769 
Net loss $   (6,956)$   (7,419)
     
Net loss per share - basic$   (0.17)$   (0.19)
Net loss per share - diluted$   (0.17)$   (0.19)
     
Weighted-average number of shares - basic    39,872,738     38,216,524 
Weighted-average number of shares - diluted    39,872,738     38,216,524 



Emergent BioSolutions Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(in thousands)
     
 Six Months Ended June 30,
 20162015
Cash flows from operating activities:(Unaudited)
     
Net loss$   (6,956)$   (7,419)
Adjustments to reconcile to net cash provided by (used in) operating activities:    
Stock-based compensation expense    9,945     7,790 
Depreciation and amortization    17,770     17,298 
Income taxes    547     630 
Change in fair value of contingent consideration    935     751 
Impairment of long-lived assets    1,114     - 
Excess tax benefits from stock-based compensation    (10,442)    (7,241)
Other    775     153 
Changes in operating assets and liabilities:    
Accounts receivable    53,933     (40,884)
Inventories    (19,738)    (19,034)
Income taxes    (14,556)    (16,740)
Prepaid expenses and other assets    (1,713)    2,465 
Accounts payable    11,287     2,062 
Accrued expenses and other liabilities    (3,533)    157 
Accrued compensation    (4,966)    (5,473)
Provision for chargebacks    274     (253)
Deferred revenue    1,007     2,368 
Net cash provided by (used in) operating activities    35,683     (63,370)
Cash flows from investing activities:    
Purchases of property, plant and equipment    (39,246)    (19,681)
Net cash used in investing activities    (39,246)    (19,681)
Cash flows from financing activities:    
Proceeds from long-term debt obligations    -     2,000 
Issuance of common stock upon exercise of stock options    14,524     13,162 
Excess tax benefits from stock-based compensation    10,442     7,241 
Contingent obligation payments    (971)    (5,002)
Net cash provided by financing activities    23,995     17,401 
     
Effect of exchange rate changes on cash and cash equivalents    168     (8)
     
Net increase (decrease) in cash and cash equivalents    20,600     (65,658)
Cash and cash equivalents at beginning of period    312,795     280,499 
Cash and cash equivalents at end of period$   333,395 $   214,841 

 


        

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