Emergent Biosolutions Inc. quarterly report, Q3 FY2020

Emergent BioSolutions Inc. — Q3 2020 Form 10-Q

Reporting period: Three and nine months ended September 30, 2020. Amounts are in millions of dollars unless noted. Comparisons are with the corresponding 2019 periods.

Business context

Emergent is a life-sciences company focused on public-health-threat products and contract development and manufacturing services (CDMO). The U.S. government is its largest customer. The company reported as one operating segment. COVID-19 vaccine manufacturing partnerships drove a significant increase in CDMO activity; travel restrictions weighed on travel-vaccine sales.

Key financial metrics

MetricQ3 2020Q3 2019Nine months 2020Nine months 2019
Total revenue$385.2$311.8$972.4$745.7
Operating income$61.3$70.7$175.7$36.4
Net income$39.5$43.2$119.7$7.6
Diluted EPS$0.73$0.83$2.23$0.15
Operating margin15.9%22.7%18.1%4.9%
Net cash from operating activitiesNot separately provided for the quarter$290.9$65.9

Operating margins are calculated from reported revenue and operating income. Nine-month operating cash flow included $14.3 of working-capital outflows; investing cash flow was negative $115.0, including $105.0 of property, plant and equipment purchases and other investing outlays. Financing cash flow was positive $71.8. Cash, cash equivalents and restricted cash ended the period at $415.2.

At September 30, 2020, total assets were $2,616.3 and stockholders’ equity was $1,251.5. Debt principal totaled $891.1; the balance-sheet carrying amount was $879.4, including current debt. Debt included $450.0 of 3.875% notes due 2028, a $427.5 term loan, $10.6 of convertible notes due 2021 and other debt; the revolver was undrawn. The company reported $597.1 of unused revolving capacity, after letters of credit.

Changes versus prior comparable periods

  • Q3 revenue rose 24%, but operating income fell 13% and net income fell 9%. CDMO revenue increased to $157.1 from $20.0, more than offsetting lower product sales, which declined 21% to $202.2.
  • Nine-month revenue grew 30%; CDMO revenue increased to $251.4 from $54.6. Product sales rose 9% to $648.9, while contracts and grants declined 27% to $72.1.
  • Nine-month anthrax-vaccine sales rose to $258.1 from $79.9, reflecting AV7909 delivery cadence and pricing. ACAM2000 sales fell to $71.0 from $164.1, primarily due to delivery timing.
  • Operating cash flow increased to $290.9 from $65.9. Cash rose from $168.0 at December 31, 2019 to $415.2 at quarter end.

Outlook, commentary, risks and unusual items

  • Management said liquidity was sufficient to fund operations for the next 12 months. No specific full-year revenue or earnings guidance is provided in the supplied filing text; management cautioned that quarterly results are variable.
  • The company reported approximately $2.2 billion of expected revenue tied to unsatisfied performance obligations and other arrangements, with a majority expected within 24 months. Timing and amount may vary with government appropriations and development outcomes; unexercised contract options are excluded.
  • COVID-19 manufacturing agreements included a $628 contract with BARDA for Operation Warp Speed, agreements with Johnson & Johnson and AstraZeneca, and a Johnson & Johnson multi-year arrangement whose first two years were valued at approximately $480. Realization depends on performance, capacity, customer programs and contract terms.
  • Q3 included a $13.8 inventory charge for travel-health products not expected to be sold before expiration because of reduced travel. The nine-month results included a $29.0 impairment of the AP004 naloxone prefilled-syringe in-process R&D asset. Contingent-consideration fair-value expense also increased materially.
  • Debt refinancing in August included issuing $450.0 of 2028 notes and using most proceeds to repay revolving-credit borrowings. The amended secured credit agreement increased the maximum net-leverage covenant; the company stated it was in compliance with covenants at filing.
  • Key risks include reliance on government procurement and appropriations, AV7909 regulatory approval and delivery, COVID-related operational or supply-chain disruption, manufacturing and supplier constraints, and reduced travel-vaccine demand. NARCAN patent litigation also remains significant: the district court ruled against the company in the Teva case, an appeal was filed, and Teva could potentially launch at risk; the PTAB upheld challenged patent claims in three reviews. Perrigo received a nonexclusive license with a stated effective date of January 5, 2033, subject to conditions.

Important facts for investors to verify

  • Whether CDMO agreements convert into timely revenue and cash flow, and whether the reported $2.2 billion of remaining performance obligations are funded and performed as expected.
  • AV7909 FDA licensure or authorization, government procurement decisions, delivery schedules and the transition from BioThrax.
  • Whether travel-health demand recovers and whether further inventory charges are needed.
  • Developments in the NARCAN appeal, potential generic entry and the terms or status of the Perrigo settlement.
  • Debt service, covenant headroom and liquidity needs alongside planned manufacturing-capacity investments.