On August 1, 2019 Emergent BioSolutions Inc. (NYSE: EBS) reported financial results for the second quarter and six months ended June 30, 2019 (Press release, Emergent BioSolutions, AUG 1, 2019, View Source [SID1234538070]).
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Q2 2019 AND RECENT BUSINESS ACCOMPLISHMENTS
Procurement
Announced the exercise by the Biomedical Advanced Research and Development Authority (BARDA) of the first contract option, valued at $261 million, to procure doses of the next generation anthrax vaccine candidate AV7909 (anthrax vaccine adsorbed with adjuvant) for delivery into the U.S. Strategic National Stockpile (SNS) over 12 months.
Awarded a 10-year procurement contract from the U.S. Department of Health and Human Services (HHS), valued at approximately $535 million, to deliver VIGIV (vaccinia immune globulin intravenous) into the SNS in support of smallpox preparedness.
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Product Development
Initiated a Phase III trial to evaluate the lot consistency, immunogenicity and safety of the next generation anthrax vaccine candidate AV7909, with funding from BARDA, pursuant to a development and procurement contract signed in September 2016; the Company also continued manufacturing of AV7909, first begun in Q1 2019, and is preparing to initiate in the third quarter the first delivery of doses of AV7909 into the SNS pursuant to the same September 2016 contract. More recently, enrollment for this Phase III trial has now been completed, ahead of schedule.
Provided interim analysis of the Phase II clinical study evaluating the safety and immunogenicity of the Company’s chikungunya virus virus-like-particle (VLP) vaccine candidate, CHIKV-VLP, showing with a single dose administered up to 98% of study participants produced neutralizing antibodies against the chikungunya virus by day 7, with persistent effect out to the six-month visit, including in the single-dose regimen.
Granted marketing authorization in five EU countries for the Company’s oral typhoid vaccine, expanding the availability of this vaccine across Europe.
Granted approval by the U.S. Food and Drug Administration (FDA) of a change in the storage conditions of the Company’s oral cholera vaccine, Vaxchora (Cholera Vaccine, Live, Oral) from frozen to 2-8 degrees Celsius as well as the transfer of bulk drug substance manufacturing from the Company’s facilities in San Diego to its manufacturing site in Bern, Switzerland.
2019 FINANCIAL PERFORMANCE (unaudited)
(I) Quarter Ended June 30, 2019 (Q2)
Revenues
Total Revenues
For Q2 2019, total revenues were $243.2 million, an increase of 10% over 2018. Total revenues reflect the contribution of recently acquired products as well as increased contracts and grants revenue.
Product Sales
For Q2 2019, product sales were $183.5 million, an increase of $3.4 million or 2% as compared to 2018. The increase primarily reflects sales of both NARCAN (naloxone HCl) Nasal Spray, which was acquired in October 2018, and other products, offset by decreased sales of ACAM2000 (Smallpox (Vaccinia) Vaccine, Live) and BioThrax (Anthrax Vaccine Adsorbed).
Contract Manufacturing
For Q2 2019, revenue from the Company’s contract manufacturing operations was $18.7 million, a decrease of $4.9 million or 21% as compared to 2018. The decrease primarily reflects contracted service work for a single customer in Q2 2018 that did not recur in Q2 2019.
Contracts and Grants
For Q2 2019, revenue from the Company’s development-based contracts and grants was $41.0 million, an increase of $24.5 million as compared to 2018. The increase primarily reflects increased R&D activities related to certain ongoing funded development programs, most notably AV7909.
Operating Expenses
Cost of Product Sales and Contract Manufacturing
For Q2 2019, cost of product sales and contract manufacturing was $100.8 million, an increase of $15.5 million or 18% as compared to 2018. The increase primarily reflects the impact of an increase in product sales due to the contribution of recently acquired products NARCAN Nasal Spray, Vivotif (Typhoid Vaccine Live Oral Ty21a), and Vaxchora, as well as an increase in facilities expenses.
Research and Development (Gross and Net)
For Q2 2019, gross R&D expenses were $63.9 million, an increase of $39.2 million or 159% as compared to 2018. The increase primarily reflects costs associated with incremental development programs from the recent acquisitions of PaxVax and Adapt Pharma in October 2018, as well as timing of manufacturing development activities related to the AV7909 program.
For Q2 2019, net R&D expense, which reflects investments made in development programs that are not currently funded in whole or in part by third-party partners and is calculated as gross research and development expenses minus contracts and grants revenue, was $22.9 million, an increase of $14.7 million or 179% as compared to 2018. The increase primarily reflects investments in the development of the CHIKV-VLP vaccine, FLU-IGIV hyperimmune and various programs related to opioid overdose response. The Q2 2019 net R&D expense was 11% of adjusted revenue (total revenue less contracts & grants) compared to 4% of adjusted revenue in Q2 2018.
Selling, General and Administrative
For Q2 2019, selling, general and administrative expenses were $70.8 million, an increase of $31.3 million or 79% as compared to 2018. The increase primarily reflects the addition of the operations and integration costs associated with the PaxVax and Adapt Pharma acquisitions.
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Amortization of Intangible Assets
For Q2 2019, amortization of intangible assets was $14.7 million versus $3.9 million as compared to 2018. The increase entirely reflects higher non-cash intangible asset amortization costs associated with the PaxVax and Adapt Pharma acquisitions.
Income Taxes
For Q2 2019, the benefit from income taxes in the amount of $5.6 million includes the impact of non-deductible acquisition transaction costs and other permanent items. The effective tax rate for Q2 2019 is not meaningful given the lack of any pre-tax income for the quarter.
Net (Loss) Income & Adjusted Net (Loss) Income
For Q2 2019, the Company recorded a net loss of $9.5 million, or $0.18 per diluted share, versus a net income of $50.1 million, or $0.98 per diluted share, in 2018.
For Q2 2019, the Company recorded an adjusted net loss of $6.3 million, or $0.12 per diluted share, versus an adjusted net income of $54.7 million, or $1.07 per diluted share, in 2018. (1)
EBITDA & Adjusted EBITDA
For Q2 2019, the Company recorded EBITDA of $21.6 million versus $79.0 million in 2018. (1)
For Q2 2019, the Company recorded adjusted EBITDA of $26.2 million versus $80.4 million in 2018. (1)
(II) Six months ended June 30, 2019 (unaudited)
Revenues
Total Revenues
For the six months ended June 30, 2019, total revenues were $433.9 million, an increase of 28% over 2018. Total revenues reflect a significant increase in product sales due to the contribution of recently acquired products.
Product Sales
For the six months ended June 30, 2019, product sales were $336.5 million, an increase of $80.7 million or 32% as compared to 2018. The increase primarily reflects sales of NARCAN Nasal Spray, which was acquired in October 2018, and other products, offset by decreased sales of ACAM2000 and BioThrax.
Contract Manufacturing
For the six months ended June 30, 2019, revenue from the Company’s contract manufacturing operations was $34.6 million, a decrease of $15.2 million or 31% as compared to 2018. The decrease primarily reflects contracted service work in the six months of 2018 that did not recur in the six months of 2019.
Contracts and Grants
For the six months ended June 30, 2019, revenue from the Company’s development-based contracts and grants was $62.8 million, an increase of $30.4 million or 94% as compared to 2018. The increase primarily reflects increased R&D activities related to certain ongoing funded development programs, most notably AV7909.
Operating Expenses
Cost of Product Sales and Contract Manufacturing
For the six months ended June 30, 2019, cost of product sales and contract manufacturing was $192.7 million, an increase of $53.3 million or 38% as compared to 2018. The increase primarily reflects the impact of an increase in product sales due to the contribution of recently acquired products NARCAN Nasal Spray, Vivotif, and Vaxchora, which were all acquired in October 2018, as well as an increase in facilities related expenses.
Research and Development (Gross and Net)
For the six months ended June 30, 2019, gross R&D expenses were $110.0 million, an increase of $56.2 million compared to 2018. The increase primarily reflects costs associated with incremental development programs from the recent acquisitions of PaxVax and Adapt Pharma in October 2018, as well as timing of manufacturing development activities related to the AV7909 program.
For the six months ended June 30, 2019, net R&D expense, which reflects investments made in development programs that are not currently funded in whole or in part by third-party partners and is calculated as gross research and development expenses minus contracts and grants revenue, was $47.2 million, an increase of $25.8 million or 121% as compared to 2018. The increase primarily reflects investments in the development of the CHIKV-VLP vaccine, FLU-IGIV hyperimmune and various programs related to opioid overdose response. The six months of 2019 net R&D expense was 13% of adjusted revenue (total revenue less contracts & grants) compared to 7% of adjusted revenue in the six months of 2018.
Selling, General and Administrative
For the six months ended June 30, 2019, selling, general and administrative expenses were $136.4 million, an increase of $56.7 million or 71% as compared to 2018. The increase primarily reflects the addition of the operations and integration costs associated with the PaxVax and Adapt Pharma acquisitions.
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Amortization of Intangible Assets
For the six months ended June 30, 2019, amortization of intangible assets was $29.2 million versus $7.8 million as compared to 2018. The increase entirely reflects higher non-cash intangible asset amortization costs associated with the PaxVax and Adapt Pharma acquisitions.
Income Taxes
For the six months ended June 30, 2019, the benefit from income taxes in the amount of $17.4 million includes the impact of non-deductible acquisition transaction costs and other permanent items. The effective tax rate for the six months of 2019 is not meaningful given the lack of any pre-tax income for the six month period.
Net (Loss) Income & Adjusted Net (Loss) Income
For the six months ended June 30, 2019, the Company recorded a net loss of $35.6 million, or $0.69 per diluted share, versus a net income of $45.2 million, or $0.89 per diluted share, in 2018.
For the six months ended June 30, 2019, the Company recorded an adjusted net loss of $0.7 million, or $0.01 per diluted share, versus an adjusted net income of $53.1 million, or $1.04 per diluted share, in 2018. (1)
EBITDA & Adjusted EBITDA
For the six months ended June 30, 2019, the Company recorded EBITDA of $19.8 million versus $82.1 million in 2018. (1)
For the six months ended June 30, 2019, the Company recorded adjusted EBITDA of $33.3 million versus $83.7 million in 2018. (1)
2019 FINANCIAL FORECAST (Reaffirmed)
For full year 2019, the company reaffirms its expectation of the following forecasted financial metrics:
The Company’s financial forecast for 2019 includes the anticipated impact of full year product sales, continued contract manufacturing and contracts & grants revenue as well as continued investment in internally funded development projects. The outlook for 2019 does not include estimates for potential new corporate development or other M&A transactions.
Q3 2019 REVENUE FORECAST
For Q3 2019, the Company forecast for total revenues is $245 million to $275 million.
FOOTNOTES
(1) See "Reconciliation of Net (Loss) Income to Adjusted Net (Loss) Income, EBITDA and Adjusted EBITDA" for a definition of terms and a reconciliation table.
CONFERENCE CALL AND WEBCAST INFORMATION
Company management will host a conference call at 5:00 pm (Eastern Time) today, August 1, 2019, 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: 8166567
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."