On May 3, 2018 Emergent BioSolutions Inc. (NYSE:EBS) reported financial results for the quarter and three months ended March 31, 2018 (Press release, Emergent BioSolutions, MAY 3, 2018, View Source;p=RssLanding&cat=news&id=2346979 [SID1234526068]).
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Q1 2018 AND RECENT BUSINESS ACCOMPLISHMENTS
Procurement Contract
Awarded a contract valued at up to $26 million over 12 months by the Centers for Disease Control and Prevention for the continued supply of VIGIV [Vaccinia Immune Globulin Intravenous (Human)] into the U.S. Strategic National Stockpile. VIGIV is the only therapeutic licensed by the U.S. Food and Drug Administration for the treatment of complications due to smallpox vaccination.
Product Development
Completed Mutual Recognition Procedure for market authorization of BioThrax (Anthrax Vaccine Adsorbed) in five Concerned Member States within the European Union – Italy, the Netherlands, Poland, the U.K. and France.
Initiated, together with Valneva, a Phase 1 clinical trial in the U.S. to evaluate the safety and immunogenicity of VLA1601, our vaccine candidate against Zika virus, using Valneva’s validated expression platform. Initial data from this trial is expected in late 2018 or early 2019.
Initiated a Phase 2 dose-ranging study to evaluate the safety, pharmacokinetics, and clinical benefit of FLU-IGIV, an anti-influenza immune globulin being developed as an intravenous treatment for serious illness caused by influenza A infection in hospitalized patients, and developed on the Company’s hyperimmune platform, on which several marketed antibody therapeutics have been licensed, including Anthrasil [Anthrax Immune Globulin Intravenous (human)] and VIGIV. The clinical study will continue to enroll patients through the next influenza season and is expected to be completed in 2019.
2018 FINANCIAL PERFORMANCE
(I) Quarter Ended March 31, 2018 (Unaudited)
Revenues
Total Revenues
For Q1 2018, total revenues were $117.8 million, a slight increase over 2017. Total revenues reflect a delay in the timing of BioThrax deliveries as previously disclosed by the Company on February 22, 2018. In addition, Q1 2018 total revenues were impacted by the delay in the delivery of some ACAM2000, (Smallpox (Vaccinia) Vaccine Live) shipments during the quarter. The Company has commenced delivery and expects to complete all delayed Q1 deliveries by the end of the second quarter.
Product Sales
For Q1 2018, product sales were $75.8 million, a decrease of 8% as compared to 2017. The decrease is principally attributable to lower BAT [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)] and BioThrax sales, partially offset by an increase in other product sales, principally attributable to sales of ACAM2000 and Raxibacumab (Anthrax Monoclonal Antibody), both of which were acquired in Q4 2017.
Contract Manufacturing
For Q1 2018, revenue from the Company’s contract manufacturing operations was $26.1 million, an increase of 48% as compared to 2017. The increase primarily reflects the completion of a milestone related to the expansion of certain contract manufacturing capabilities at the Company’s Lansing site.
Contracts and Grants
For Q1 2018, contracts and grants revenue was $15.9 million, a decrease of 8% as compared to 2017. The decrease primarily reflects a reduction in revenue associated with the successful completion of multiple U.S. government development 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 Q1 2018, cost of product sales and contract manufacturing was $58.0 million, an increase of 25% as compared to 2017. The increase is primarily attributable to sales of ACAM2000 and Raxibacumab, both of which were acquired in Q4 2017, partially offset by lower sales of BAT and BioThrax.
Research and Development (Gross and Net)
For Q1 2018, gross R&D expenses were $29.1 million, an increase of 42% as compared to 2017. The increase primarily reflects increased contract development services performed for NuThraxTM (anthrax vaccine adsorbed with CPG 7909 adjuvant) and the introduction of costs associated with development work related to the technology transfer of the Raxibacumab manufacturing process to the Company’s Bayview manufacturing site in Baltimore.
For Q1 2018, net R&D expense (calculated as gross research and development expenses minus contracts and grants revenue) was $13.2 million, an increase of $10 million as compared to 2017, reflecting increased investment in countermeasure development programs not currently funded in whole or in part by third-party partners, notably costs associated with the Raxibacumab technology transfer, the FLU-IGIV flu therapeutic Phase 2 trial, the ZIKV-IG Zika therapeutic Phase 1 trial preparations, and the UNI-FLU universal flu vaccine preclinical effort, among others.
Selling, General and Administrative
For Q1 2018, selling, general and administrative expenses were $40.2 million, an increase of $5 million as compared to 2017, attributable primarily to increased stock compensation and professional services costs.
Income Taxes
For Q1 2018, the tax benefit in the amount of $4.5 million includes a discrete benefit of $2.3 million related to stock compensation activity resulting in an effective tax rate of 48%. Excluding the discrete benefit, the Q1 2018 effective tax rate was 24%.
Net Income (Loss) & Adjusted Net Income (Loss)
For Q1 2018, the Company recorded a net loss of $4.9 million, or $0.10 per diluted share, versus net income of $10.5 million, or $0.23 per diluted share, in 2017. (1)
For Q1 2018, the Company recorded an adjusted net loss of $1.6 million, or $0.03 per diluted share, versus net income of $14.3 million, or $0.29 per diluted share, in 2017. (1) (2)
The Company is also reaffirming its full year 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 technology transfer to the Company’s 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
Q2 2018 FINANCIAL FORECAST
The Company forecast for Q2 2018 total revenue is $205 million to $230 million. This forecast reflects the deliveries of BioThrax and ACAM2000 previously expected in the first quarter as well as continued deliveries of both products in the second quarter.
FOOTNOTES
(1) See "Calculation of Diluted Earnings Per Share."
(2) See "Reconciliation of Net Income to Adjusted Net Income and EBITDA" for a definition of terms and a reconciliation table.
(3) Reflects an estimated tax rate that includes the expected effects of the United States Tax Cuts and Jobs Act of 2017 on the Company’s 2018 income tax provision.
(4) "Net revenue" is computed as Total Revenue minus Contracts & Grants Revenue.
CONFERENCE CALL AND WEBCAST INFORMATION
Company management will host a conference call at 5:00 pm (Eastern Time) today, May 3, 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: [US] (855) 766-6521; [International] (262) 912-6157
Conference ID: 93329114
Live Webcast Information:
Visit View Source for the live webcast feed.
A replay of the call can be accessed at www.emergentbiosolutions.com under "Investors."