On August 4, 2016 Emergent BioSolutions Inc. (NYSE:EBS) reported financial results for the quarter and six months ended June 30, 2016 (Press release, Emergent BioSolutions, AUG 4, 2016, View Source;p=RssLanding&cat=news&id=2193280 [SID:1234514252]).
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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