Emergent BioSolutions Reports Financial Results For First Quarter 2022
- Reports Q1 2022 total revenues of
$308M , in line with guidance, and Adjusted EBITDA of$36M - Temporarily suspends CDMO guidance pending further clarity on COVID-19 vaccine requirements
“Emergent remains focused on our strategic plan to grow within public health threat markets where we can positively impact patients and customers,” said
FINANCIAL HIGHLIGHTS (1)
($ in millions, except per share amounts) | Q1 2022 | Q1 2021 | % Change |
Total Revenues | (10)% | ||
Net (Loss) Income | * | ||
Net (Loss) Income per Diluted Share | * | ||
Adjusted Net Income (Loss)(2) | (89)% | ||
Adjusted Net Income (Loss)(2)per Diluted Share | (88)% | ||
Adjusted EBITDA(2) | (71)% | ||
Gross Margin %(2) | 48% | 69% | |
Adjusted Gross Margin %(2) | 48% | 69% | |
* % change is greater than 100% |
SELECT Q1 2022 AND OTHER RECENT BUSINESS UPDATES
- Completed the rolling submission to the
U.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) for AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted), the Company's new anthrax vaccine candidate. - Announced updates to the Company's corporate governance:
- Appointed
Zsolt Harsanyi , Ph.D., as Chairman of the Board of Directors; and - Appointed
Keith Katkin to the Board of Directors.
- Appointed
- Strengthened the Company's senior leadership with three key hires:
Coleen Glessner joined as EVP, Global Quality and Ethics and Compliance, reporting to the CEO;Bill Hartzel joined as SVP and Head of the CDMO Services business, reporting to the COO; andJoseph Philipose joined as SVP and Chief Ethics and Compliance Officer, reporting to the EVP, Global Quality and Ethics and Compliance.
- Initiated a Phase 1 study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of stabilized isoamyl nitrite (SIAN), a treatment being developed for known or suspected acute cyanide poisoning, with funding from the
Biomedical Advanced Research and Development Authority (BARDA) and in collaboration withSouthwest Research Institute .
- Continued to repurchase the Company's common stock under an existing authorization by the Board of Directors to management to repurchase up to
$250 million throughNovember 11, 2022 ; during the quarter endedMarch 31, 2022 , the Company purchased an additional 1.1 million shares for$52.2 million , resulting in an aggregate of approximately 3.8 million shares for$164.7 million since initiating repurchases in Q4 2021.
Q1 2022 FINANCIAL PERFORMANCE (1)
Revenues
($ in millions) | Q1 2022 | Q1 2021 | % Change | ||
Product sales, net (3): | |||||
• Anthrax vaccines | 88% | ||||
• Nasal naloxone products | 25% | ||||
• ACAM2000® | $— | * | |||
• Other (4) | * | ||||
Total product sales, net | 72% | ||||
Contract development and manufacturing (CDMO): | |||||
• Services | (23)% | ||||
• Leases | (92)% | ||||
Total CDMO | (67)% | ||||
Contracts and grants | (55)% | ||||
Total revenues | (10)% | ||||
* % change is greater than 100% |
Product Sales, net
Anthrax vaccines
For Q1 2022, revenues from Anthrax vaccines increased
Nasal naloxone products
For Q1 2022, revenues from nasal naloxone products increased
ACAM2000
For Q1 2022, revenues from ACAM2000® (Smallpox (Vaccinia) Vaccine, Live) increased
Other (4)
For Q1 2022, revenues from other product sales increased
CDMO Services
For Q1 2022, revenue from contract development and manufacturing services decreased
CDMO Leases
For Q1 2022, revenue from contract development and manufacturing leases decreased
Contracts and Grants
For Q1 2022, revenues from contracts and grants decreased
Operating Expenses
($ in millions) | Q1 2022 | Q1 2021 | % Change | ||
Cost of product sales | 53% | ||||
Cost of CDMO | 62% | ||||
Research and development | (12)% | ||||
Selling, general and administrative | 5% | ||||
Amortization of intangible assets | (6)% | ||||
Total operating expenses |
Cost of Product Sales
For Q1 2022, cost of product sales increased
Cost of CDMO
For Q1 2022, cost of CDMO increased
Research and Development
For Q1 2022, research and development expenses decreased
Selling, General and Administrative
For Q1 2022, selling, general and administrative expenses increased
Additional Financial Information
Segment Information
During Q1 2022, the Company began assessing its operating performance by focusing on two reportable segments: 1) a products segment (Product) consisting of the Government/Medical Countermeasure (MCM) and Commercial products business lines; and 2) a services segment (Services) consisting of the CDMO services business line. The Company evaluates the performance of these reportable segments based on revenue and adjusted gross margin. Segment revenue includes external customer sales but does not include inter-segment services. The Company does not allocate Contracts and grants, R&D, SG&A, amortization of intangible assets, interest and other income (expense) or taxes to its evaluation of the performance of these segments.
($ in millions) |
Products | Services | ||||
Q1 2022 | Q1 2021 | % Change | Q1 2022 | Q1 2021 | % Change | |
Revenue | 72% | (67)% | ||||
Cost of sales | 53% | 62% | ||||
Less: Changes in fair value of contingent consideration | (55)% | $— | $— | $— | ||
Adjusted cost of sales | 55% | 62% | ||||
Gross margin ** | 84% | * | ||||
Gross margin % ** | 66% | 62% | 400 bps | (24)% | 75% | * |
Adjusted gross margin *** | 82% | * | ||||
Adjusted gross margin % *** | 66% | 63% | 300 bps | (24)% | 75% | * |
* % change is greater than 100% or not considered meaningful | ||||||
** Gross margin is calculated as Revenue less cost of sales. Gross margin % is calculated as gross margin divided by Revenue. | ||||||
*** Adjusted gross margin is calculated as Revenue less Adjusted cost of sales. Adjusted gross margin % is calculated as Adjusted gross margin divided by Revenue. |
For Q1 2022, Product margin increased
For Q1 2022, Services gross margin and adjusted gross margin decreased
CDMO Metrics
($ in millions, except CDMO customers) | As of |
As of |
% Change | |
CDMO Customers (5) | 71 | 70 | 1% |
($ in millions) | In Q122 | In Q421 | % Change | |||
CDMO New Business Secured (6) | (37)% |
For Q1 2022, the Company is temporarily suspending disclosing CDMO Backlog as of
Capital Expenditures
($ in millions) | Q1 2022 | Q1 2021 | % Change |
Gross capital expenditures | (43)% | ||
Less: capital expenditures reimbursed | $— | (100)% | |
Net capital expenditures | * | ||
Gross capital expenditures as a % of total revenues | 10% | 16% | (6)% |
Net capital expenditures as a % of total revenues | 10% | 14% | (4)% |
* % change is greater than 100% |
For Q1 2022, capital expenditures decreased largely due to less spending associated with the expansion project at the Company's
2022 FINANCIAL FORECAST
The Company provides the following update to its full year 2022 forecast.
Reaffirmed Guidance
The following revenue guidance is reaffirmed for full year 2022 ($ in millions):
• Anthrax Vaccines | |
• ACAM2000 | |
• Nasal Naloxone Products | |
• Other Products + Contracts and Grants |
Temporarily Suspended Guidance
Following the recent decision by Johnson & Johnson (J&J) to suspend projecting COVID-19 vaccine sales for 2022 due to global supply surplus and vaccine hesitancy in the developing world, the Company's 2022 revenues related to its commercial supply arrangement with J&J are uncertain. Accordingly, the following metrics are temporarily suspended for full year 2022 pending further clarity on J&J COVID-19 vaccine requirements:
- CDMO Revenues
- Total Revenues
- Adjusted Net Income
- Adjusted EBITDA
- Gross Margin
At the appropriate time, the Company will communicate additional information and update the overall forecast.
Assumptions
The Company's 2022 financial forecast also takes into consideration the following assumptions.
2022 Product and Contract and Grant Revenues
- Anthrax vaccines revenues are expected to continue at similar levels to 2021 under the terms of the Company's existing contract with BARDA.
- ACAM2000 vaccine deliveries are expected to continue under the terms of the Company’s existing contract with the
U.S. Department of Health and Human Services (HHS) at unit volume levels consistent with 2021 deliveries. - Nasal naloxone products revenues reflect the formation of a generic market and comprise revenues from a combination of NARCAN Nasal Spray and the authorized generic of NARCAN Nasal Spray, a product licensed to Sandoz and launched in late 2021 and one in which the Company retains a financial interest.
- Other Products + Contracts and Grants revenues: 1) other products revenues reflect continued procurement of other products not highlighted on a standalone basis from various government customers under existing multi- year contracts; 2) contracts and grants revenues reflect continued funding of select development programs from various government and other non-dilutive sources.
Other
- Pipeline progress is expected across the R&D portfolio with the ongoing advancement of the CHIKV VLP Phase 3 clinical trial, the completion of the BLA filing for AV7909, and anticipated advancements of a number of early- stage programs.
- Capital expenditures, net of reimbursement, are expected to be approximately 10% of total revenues at the midpoint, reflecting ongoing investments in capacity and capability expansions related to the CDMO business and the Company's R&D programs, and aligned with the average over the previous five-year period.
FOOTNOTES
(1) All financial information incorporated within this release is unaudited.
(2) See "Reconciliation of Net Income to Adjusted Net Income," "Reconciliation of Net Income to Adjusted EBITDA," and "Adjusted Revenues" for a definition of terms and the reconciliation tables.
(3) Product sales, net are reported net of variable consideration including returns, rebates, wholesaler fees and prompt pay discounts in accordance with
(4) Other can include a combination of sales of any of the following products: BAT, VIGIV, Anthrasil, raxibacumab, RSDL, Trobigard, Vivotif, and Vaxchora.
(5) CDMO Customer is defined as a client (commercial, government, NGO) for whom the Company has performed CDMO services where there is evidence of meeting all of the following criteria: i) completion of any billable project milestones in the preceding 24-month period, indicating ongoing work; ii) secured project work planned in the future, which has not yet been invoiced, capturing future work not yet indicated in the invoice record; and, iii) neither the Company nor the client having yet to formally terminate the last remaining project, thereby removing any client for whom work has fully concluded.
(6) CDMO New Business Secured is defined as initial value of contracts secured as well as incremental value of existing contracts modified within the indicated period.
CONFERENCE CALL, PRESENTATION SUPPLEMENT AND WEBCAST INFORMATION
Company management will host a conference call at
Live Teleconference Information:
Dial in: [US] (855) 766-6521; [International] (262) 912-6157
Conference ID: 3691528
Live Webcast Information:
Visit https://edge.media-server.com/mmc/p/84272zeq for the webcast.
A replay of the call can be accessed from the Company website.
ABOUT
At Emergent, our mission is to protect and enhance life. For over 20 years, we’ve been at work defending people from things we hope will never happen—so we are prepared just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers. To learn more about how we plan to protect or enhance 1 billion lives by 2030, visit our website and follow us on LinkedIn, Twitter, and Instagram.
RECONCILIATION OF NON-GAAP MEASURES
This press release contains financial measures (Adjusted Net Income, Adjusted EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization), Adjusted Gross Margin, Adjusted Product Gross Margin, Adjusted CDMO Gross Margin,
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.
SAFE HARBOR STATEMENT
This earnings 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, certain future financial metrics and related projections and statements regarding our ability to meet such projections in the anticipated timeframe, if at all, and more specifically, statements regarding our 2022 anthrax vaccine revenues and the timing of expected deliveries of AV7909, 2022 ACAM2000 revenues and the timing of related deliveries, 2022 nasal naloxone product revenues and the impact of the generic market on NARCAN Nasal Spray and anticipated financial benefits from our financial interest in the authorized generic launched by Sandoz; 2022 other products and contracts and grants revenues and continued procurement of other products not highlighted on a standalone basis, the continuation of stable base revenues from certain multi-year MCM procurement contracts; the continued demand for naloxone products in the
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 statements speak only as of the date of the earnings press release and investor presentation, 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 our actual results to differ materially from those indicated by such forward-looking statements, including the availability of
Investor Contact
Vice President, Investor Relations
burrowsr@ebsi.com
(240) 413-1917
Media Contact
Senior Director, Media Relations
mediarelations@ebsi.com
Condensed Consolidated Balance Sheets
(unaudited, in millions, except per share data)
ASSETS | |||||
Current assets: Cash and cash equivalents |
$ |
435.8 |
$ |
576.1 |
|
Restricted cash | 0.2 | 0.2 | |||
Accounts receivable, net | 181.8 | 274.7 | |||
Inventories, net | 400.7 | 350.8 | |||
Prepaid expenses and other current assets | 81.8 | 70.3 | |||
Total current assets | 1,100.3 | 1,272.1 | |||
Property, plant and equipment, net |
807.5 |
800.1 |
|||
Intangible assets, net | 590.6 | 604.6 | |||
224.9 | 224.9 | ||||
Other assets | 57.1 | 57.3 | |||
Total assets | $ | 2,780.4 | $ | 2,959.0 |
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable | $ | 107.3 | $ | 128.9 | |
Accrued expenses | 29.3 | 51.7 | |||
Accrued compensation | 56.4 | 88.7 | |||
Debt, current portion | 31.6 | 31.6 | |||
Other current liabilities | 24.6 | 72.9 | |||
Total current liabilities | 249.2 | 373.8 | |||
Contingent consideration, net of current portion | 4.4 | 4.5 | |||
Debt, net of current portion | 801.5 | 809.4 | |||
Deferred tax liability | 94.8 | 94.9 | |||
Contract liabilities, net of current portion | 5.9 | 4.7 | |||
Other liabilities | 49.3 | 52.7 | |||
Total liabilities | $ | 1,205.1 | $ | 1,340.0 | |
Stockholders' equity: | |||||
Preferred stock, |
— | — | |||
Common stock, |
0.1 | 0.1 | |||
Additional paid-in capital | 834.8 | 829.4 | |||
(204.4) | (152.2) | ||||
Accumulated other comprehensive loss, net | (9.3) | (16.1) | |||
Retained earnings | 954.1 | 957.8 | |||
Total stockholders' equity | 1,575.3 | 1,619.0 | |||
Total liabilities and stockholders' equity | 2,780.4 | 2,959.0 |
Condensed Consolidated Statements of Operations
(unaudited, in millions, except per share data)
Three Months Ended |
|||||||
2022 | 2021 | ||||||
Revenues: | |||||||
Product sales, net | $ | 237.1 | $ | 137.9 | |||
Contract development and manufacturing: | |||||||
Services | 51.8 | 67.6 | |||||
Leases | 9.0 | 116.2 | |||||
Total contract development and manufacturing | 60.8 | 183.8 | |||||
Contracts and grants | 9.6 | 21.3 | |||||
Total revenues | 307.5 | 343.0 | |||||
Operating expenses: | |||||||
Cost of product sales | 80.3 | 52.6 | |||||
Cost of contract development and manufacturing | 75.6 | 46.7 | |||||
Research and development | 46.4 | 52.5 | |||||
Selling, general and administrative | 84.8 | 80.9 | |||||
Amortization of intangible assets | 14.0 | 14.9 | |||||
Total operating expenses | 301.1 | 247.6 | |||||
Income (loss) from operations | 6.4 | 95.4 | |||||
Other income (expense): | |||||||
Interest expense | (8.2 | ) | (8.5 | ) | |||
Other, net | (2.0 | ) | (1.7 | ) | |||
Total other income (expense), net | (10.2 | ) | (10.2 | ) | |||
Income (loss) before income taxes |
(3.8 |
) |
85.2 |
||||
Income taxes | 0.1 | (15.5 | ) | ||||
Net income (loss) | $ | (3.7 | ) | $ | 69.7 | ||
Net (loss) income per common share* |
|||||||
Basic | $ | (0.07 | ) | $ | 1.31 | ||
Diluted | $ | (0.07 | ) | $ | 1.28 |
Shares used in computing net income (loss) per common share
Basic | 50.7 | 53.3 | |||||
Diluted | 50.7 | 54.5 |
* Any differences in the calculation of net income per common share is due to rounding.
Condensed Consolidated Statements of Cash Flows
(unaudited, in millions)
Three Months Ended |
|||||||||
2022 | 2021 | ||||||||
Cash flows (used in) provided by operating activities: | |||||||||
Net income (loss) | $ | (3.7 | ) | $ | 69.7 | ||||
Adjustments to reconcile net income to net cash (used in) provided by operating activities: | |||||||||
Share-based compensation expense | 9.9 | 10.5 | |||||||
Depreciation and amortization | 30.9 | 28.7 | |||||||
Change in fair value of contingent consideration, net | 0.5 | 1.1 | |||||||
Amortization of deferred financing costs | 1.0 | 1.0 | |||||||
Deferred income taxes | 1.9 | (1.7 | ) | ||||||
Other | 0.6 | 3.5 | |||||||
Changes in operating assets and liabilities: | |||||||||
Accounts receivable | 93.7 | 42.1 | |||||||
Inventories | (50.1 | ) | (99.9 | ) | |||||
Prepaid expenses and other assets | (16.6 | ) | (10.0 | ) | |||||
Accounts payable | (14.7 | ) | 20.1 | ||||||
Accrued expenses and other liabilities | (56.5 | ) | (40.0 | ) | |||||
Accrued compensation | (32.2 | ) | (29.4 | ) | |||||
Contract liabilities | (2.0 | ) | 9.4 | ||||||
Net cash (used in) provided by operating activities: | (37.3 | ) | 5.1 | ||||||
Cash flows used in investing activities: | |||||||||
Purchases of property, plant and equipment | (32.2 | ) | (56.1 | ) | |||||
Net cash used in investing activities: | (32.2 | ) | (56.1 | ) | |||||
Cash flows used in financing activities: | |||||||||
Purchases of treasury stock | (57.5 | ) | — | ||||||
Principal payments on term loan facility | (8.5 | ) | (5.6 | ) | |||||
Principal payments on convertible senior notes | — | (10.6 | ) | ||||||
Proceeds from share-based compensation activity | 0.5 | 6.9 | |||||||
Taxes paid for share-based compensation activity | (5.0 | ) | (12.2 | ) | |||||
Contingent consideration payments | — | (0.7 | ) | ||||||
Net cash used in financing activities: | (70.5 | ) | (22.2 | ) | |||||
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (0.3 | ) | (0.3 | ) | |||||
Net change in cash, cash equivalents and restricted cash | (140.3 | ) | (73.5 | ) | |||||
Cash, cash equivalents and restricted cash at beginning of period | 576.3 | 621.5 | |||||||
Cash, cash equivalents and restricted cash at end of period | $ | 436.0 | $ | 548.0 |
Reconciliation of Net Income to Adjusted Net Income (1)
($ in millions, except per share value) |
Three Months Ended |
||
2022 | 2021 | Source | |
Net income (loss) | |||
Adjustments: | |||
Plus: Non-cash amortization charges | 15.1 | 16.0 | Intangible Asset (IA) Amortization, Other Income |
Plus: Changes in fair value of contingent consideration | 0.5 | 1.1 | Product COGS |
Plus: Acquisition-related costs (transaction & integration) | 0.4 | 0.2 | SG&A |
Tax effect | (3.2) | (3.4) | |
Total adjustments: | |||
Adjusted net income (loss) | |||
Adjusted net income (loss) per diluted share |
Reconciliation of Net Income to Adjusted EBITDA (1)
($ in millions) |
Three Months Ended |
|
2022 | 2021 | |
Net income (loss) | ||
Adjustments: | ||
Plus: Depreciation & amortization | 30.9 | 28.7 |
Plus: Income taxes | (0.1) | 15.5 |
Plus: Total interest expense, net | 8.0 | 8.3 |
Plus: Changes in fair value of contingent consideration | 0.5 | 1.1 |
Plus: Acquisition-related costs (transaction & integration) | 0.4 | 0.2 |
Total adjustments | ||
Adjusted EBITDA |
Reconciliation of Gross Margin and Adjusted Gross Margin (1)
($ in millions) | Three Months Ended |
|
2022 | 2021 | |
Total revenues | ||
Less: Contracts and grants revenues | 9.6 | 21.3 |
Adjusted revenues | ||
Cost of product sales | 80.3 | 52.6 |
Cost of contract development and manufacturing | 75.6 | 46.7 |
Cost of product sales and cost of contract development and manufacturing services ("COGS") | 155.9 | 99.3 |
Less: Changes in fair value of contingent consideration | 0.5 | 1.1 |
Adjusted COGS | ||
Gross margin (adjusted revenues minus COGS) | ||
Gross margin % (gross margin divided by adjusted revenues) | 48% | 69% |
Adjusted gross margin (adjusted revenues minus adjusted COGS) | ||
Adjusted gross margin % (adjusted gross margin divided by adjusted revenues) | 48% | 69% |
Reconciliation of
($ in millions) | Three Months Ended |
|
2022 | 2021 | |
Research and development expenses | ||
Adjustments: | ||
Less: Contracts and grants revenue | 9.6 | 21.3 |
Net research and development expenses | 36.8 | 31.2 |
Adjusted revenue (Total revenue less contracts and grants revenue) | ||
Net R&D as % of adjusted revenue (Net R&D margin) | 12% | 10% |

Source: Emergent BioSolutions