Emergent BioSolutions Reports Second Quarter and Six Months 2016 Financial Results
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) bySeptember 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 theBiomedical 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 bySeptember 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
Revenues
Product Sales
For Q2 2016, product sales were
(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
Contracts, Grants and Collaborations
For Q2 2016, contracts, grants and collaborations revenue was
Operating Expenses
Cost of Product Sales and Contract Manufacturing
For Q2 2016, cost of product sales and contract manufacturing was
Research and Development
For Q2 2016, gross research and development (R&D) expenses were
For Q2 2016, net R&D expenses were
| (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
Net Income/(Loss)
For Q2 2016, GAAP net loss was
(II) Six Months Ended
Revenues
Product Sales
For the six months of 2016, product sales were
(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
Contracts, Grants and Collaborations
For the six months of 2016, contracts, grants and collaborations revenue was
Operating Expenses
Cost of Product Sales and Contract Manufacturing
For the six months of 2016, cost of product sales and contract manufacturing was
Research and Development
For the six months of 2016, gross research and development (R&D) expenses were
For the six months of 2016, net R&D expenses were
| (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
Net Loss
For the six months of 2016, GAAP net loss was
(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
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
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
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
FINANCIAL STATEMENTS FOLLOW
| Emergent BioSolutions Inc. and Subsidiaries | ||||||||
| Consolidated Balance Sheets | ||||||||
| (in thousands, except share and per share data) | ||||||||
| June 30, 2016 | December 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, | ||||||||
| 2016 | 2015 | |||||||
| (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, | ||||||||
| 2016 | 2015 | |||||||
| (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, | ||||||||
| 2016 | 2015 | |||||||
| 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 | ||||
Investor Contact
Robert Burrows
Vice President, Investor Relations
(o) 240/631-3280; (m) 240/413-1917
burrowsr@ebsi.com
Media Contact
Tracey Schmitt Lintott
Senior Vice President, Global Public Affairs
(o) 240/631-3394
schmittt@ebsi.com