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Syneos Health Reports Third Quarter 2021 Results

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Highlights

  • Third quarter revenue of $1,348.2 million increased 22.7% year-over-year.
  • Clinical Solutions net new business awards of $1,353.8 million for the third quarter, representing year-over-year growth of 35.0% and a book-to-bill ratio of 1.30x, and $5,322.2 million for the trailing twelve months, representing year-over-year growth of 12.3% and a book-to-bill ratio of 1.39x.
  • Commercial Solutions net new business awards of $276.9 million for the third quarter, representing year-over-year growth of 36.3% and a book-to-bill ratio of 0.89x, and $1,331.1 million for the trailing twelve months, representing year-over-year growth of 15.5% and a book-to-bill ratio of 1.16x.
  • Year-over-year ending backlog growth of 22.3% in Clinical Solutions and 24.9% in Deployment Solutions as of September 30, 2021.
  • GAAP net income of $78.2 million increased from $63.4 million in the third quarter of 2020.
  • Adjusted EBITDA of $202.6 million increased 10.8% year-over-year.
  • GAAP diluted earnings per share of $0.75 increased from $0.60 in the third quarter of 2020.
  • Adjusted diluted earnings per share of $1.22 increased 17.3% year-over-year.
  • Closed the acquisition of StudyKIK, a leading technology-enabled clinical trial recruitment and retention company.

MORRISVILLE, N.C., Nov. 03, 2021 (GLOBE NEWSWIRE) — Syneos Health (Nasdaq:SYNH), the only fully integrated biopharmaceutical solutions organization, today reported financial results for the three and nine months ended September 30, 2021.

“We delivered another strong quarter of results demonstrating the strength of our differentiated product development strategy and continued momentum in the market, exceeding the midpoint of our guidance across all financial metrics,” said Alistair Macdonald, CEO, Syneos Health. “Our Clinical and Commercial teams again achieved double-digit growth fueled by strong demand for our innovative, integrated solutions, as demonstrated by our robust awards and backlog. We also recently closed our acquisitions of StudyKIK, a clinical trial recruitment and retention company, and RxDataScience, a data analytics, data management and Artificial Intelligence company. These acquisitions will further enable Syneos Health to deliver new tech-enabled, insights-powered capabilities to customers helping us achieve our goal of shortening the distance from lab to life.”

Please refer to the “Use of Non-GAAP Financial Measures” and “Reconciliation of GAAP to Non-GAAP Measures” included in this press release and accompanying tables for important disclosures about non-GAAP measures and a reconciliation of these measures to the nearest GAAP measures.

Third Quarter 2021 Results

Revenue of $1,348.2 million increased 22.7% on a reported basis and 22.0% on a constant currency basis for the three months ended September 30, 2021, compared to the same period in the prior year, due in part to the prior period being impacted by the COVID-19 pandemic. Clinical Solutions revenue increased 23.9% on a reported basis and 23.1% on a constant currency basis to $1,037.4 million. Acquisitions contributed approximately 975 basis points to Clinical Solutions reported revenue growth. Commercial Solutions revenue increased 18.7% on a reported basis and 18.4% on a constant currency basis to $310.8 million. The divestiture of medication adherence resulted in an approximate 310 basis point headwind to Commercial Solutions reported revenue growth. Prior period segment results have been recast to reflect the move of Regulatory and Operations Consulting from Commercial Solutions to Clinical Solutions.

GAAP net income for the three months ended September 30, 2021 increased 23.4% to $78.2 million, resulting in diluted earnings per share of $0.75, compared to GAAP net income of $63.4 million, or diluted earnings per share of $0.60, for the three months ended September 30, 2020. Adjusted net income for the three months ended September 30, 2021 increased 16.0% to $127.8 million, resulting in adjusted diluted earnings per share of $1.22, compared to adjusted net income of $110.2 million, or adjusted diluted earnings per share of $1.04, for the three months ended September 30, 2020.

Adjusted EBITDA for the three months ended September 30, 2021 increased 10.8% to $202.6 million from the same period in the prior year.

Year-to-Date 2021 Results

Revenue of $3,839.6 million increased 17.2% on a reported basis and 15.7% on a constant currency basis for the nine months ended September 30, 2021, compared to the same period in the prior year, due in part to the prior period being impacted by the COVID-19 pandemic. Clinical Solutions revenue increased 19.8% on a reported basis and 18.1% on a constant currency basis to $2,966.5 million. Acquisitions contributed approximately 770 basis points and the divestiture of contingent staffing resulted in an approximate 80 basis point headwind to Clinical Solutions reported revenue growth. Commercial Solutions revenue increased 9.1% on a reported basis and 8.4% on a constant currency basis to $873.0 million. The divestiture of medication adherence resulted in an approximate 270 basis point headwind to Commercial Solutions reported revenue growth. Prior period segment results have been recast to reflect the move of Regulatory and Operations Consulting from Commercial Solutions to Clinical Solutions.

GAAP net income for the nine months ended September 30, 2021 increased 57.5% to $158.9 million, resulting in diluted earnings per share of $1.51, compared to GAAP net income of $100.9 million, or diluted earnings per share of $0.96, for the nine months ended September 30, 2020. Adjusted net income for the nine months ended September 30, 2021 increased 29.0% to $312.7 million, resulting in adjusted diluted earnings per share of $2.98, compared to adjusted net income of $242.4 million, or adjusted diluted EPS of $2.30, for the nine months ended September 30, 2020.

Adjusted EBITDA for the nine months ended September 30, 2021 increased 20.4% to $528.4 million from the same period in the prior year.

Net New Business Awards and Backlog

Net new business awards and book-to-bill ratios for the three and twelve months ended September 30, 2021 were as follows (in millions):

         
                     
     
                         
                         
                         
    Three Months Ended
September 30, 2021
  Twelve Months Ended
September 30, 2021
         
                     
     
                         
                         
                         
    Net new
business
awards
    Book-to-bill
ratio
  Net new
business
awards
    Book-to-bill
ratio
         
                     
     
                         
                         
                         
    (dollars in millions)
         
                     
     
                         
                         
                         
Clinical Solutions   $ 1,353.8     1.30x   $ 5,322.2     1.39x
         
                     
     
                         
                         
                         
Commercial Solutions     276.9     0.89x     1,331.1     1.16x
         
                     
     
                         
                         
                         
Total   $ 1,630.7     1.21x   $ 6,653.3     1.34x

Our backlog as of September 30, 2021 was as follows (in millions):

    2021     2020     Growth %  
Clinical Solutions   $ 11,281.4     $ 9,222.4       22.3 %
Commercial Solutions – Deployment Solutions     732.8       586.7       24.9 %
Total backlog   $ 12,014.2     $ 9,809.1       22.5 %

Liquidity and Capital Management Update

Cash flows provided by operating activities were $48.5 million and $264.3 million during the three and nine months ended September 30, 2021, respectively.

On October 13, 2021, the Company further amended its accounts receivable financing agreement to increase the amount it can borrow from $365.0 million to $400.0 million, extended the maturity to October 2024, and drew down the additional $35.0 million. At the same time, the Company paid down $35.0 million on the facilities under its Credit Agreement, resulting in no net impact on leverage.

During the three months ended September 30, 2021, the Company did not repurchase common stock. During the nine months ended September 30, 2021, the Company repurchased $117.5 million of common stock and has $182.5 million of remaining share repurchase authorization available through December 31, 2022.

Full Year 2021 Business Outlook

The Company’s guidance takes into account a number of factors, including existing backlog, current sales pipeline, trends in cancellations and delays, and the Company’s ForwardBound initiative, which includes expansion of the Syneos Operations Network, process optimization, and automation initiatives. In addition, the guidance presented below represents the Company’s best efforts to estimate the impact of COVID-19 on its business. The severity and duration of the COVID-19 pandemic are outside of the Company’s control and, given the uncertain nature of the pandemic, could cause the Company’s future operating results to be different from our current expectations, particularly if the impact of the pandemic worsens. Furthermore, the guidance presented below is based on current foreign currency exchange rates, current interest rates, and the Company’s expected non-GAAP effective tax rate of approximately 24.0% for the year ending December 31, 2021. The guidance is based upon the Company’s estimated number of weighted average diluted shares outstanding, and does not take into account any share repurchases beyond the third quarter of 2021. The Company’s full year 2021 guidance is outlined below:

    Previous Guidance issued August 9, 2021     Updated Guidance issued November 3, 2021  
    FY 2021     FY 2021  
    Low     High     Low     High  
    (in millions, except per share data)     (in millions, except per share data)  
Revenue   $ 5,180.0     $ 5,300.0     $ 5,200.0     $ 5,280.0  
GAAP Net Income     206.6       222.0       228.9       242.2  
GAAP Diluted EPS     1.96       2.11       2.18       2.30  
Adjusted EBITDA     750.0       780.0       755.0       775.0  
Adjusted Diluted EPS   $ 4.25     $ 4.43     $ 4.35     $ 4.49  

Webcast and Conference Call Details

Syneos Health will host a conference call at 8:00 a.m. ET on November 3, 2021, to discuss its third quarter 2021 financial results. The live webcast will be available in listen-only mode in the Events section of the Company’s Investor Relations website at investor.syneoshealth.com. To participate via phone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call.

An archived replay of the conference call is expected to be available online at investor.syneoshealth.com after 1:00 p.m. ET on November 3, 2021.

About Syneos Health

Syneos Health® (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. The Company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Syneos Health brings together approximately 28,000 clinical and commercial minds with the ability to support customers in more than 110 countries. The Company shares insights, uses the latest technologies, and applies advanced business practices to speed its customers’ delivery of important therapies to patients. To learn more about how Syneos Health is shortening the distance from lab to life® visit syneoshealth.com.

Forward-Looking Statements

Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including the future impact of the COVID-19 pandemic on our business, financial results and financial condition, anticipated financial results for the full year 2021, benefits of recent acquisitions and plans for capital deployment. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include, but are not limited to: risks associated with the COVID-19 pandemic; the Company’s potential failure to generate a large number of new business awards and the risk of delay, termination, reduction in scope, or failure to go to contract of business awards; the Company’s potential failure to convert backlog to revenue; fluctuations in the Company’s operating results and effective income tax rate; the impact of potentially underpricing the Company’s contracts, overrunning cost estimates, or failing to receive approval for or experiencing delays with documentation of change orders; cyber-security and other risks associated with the Company’s information systems infrastructure; changes and costs of compliance with regulations related to data privacy; concentration of the Company’s customers or therapeutic areas; the risks associated with doing business internationally; risks related to the impact of the U.K.’s withdrawal from the European Union; challenges by tax authorities of the Company’s intercompany transfer pricing policies; the Company’s potential failure to successfully increase its market share, grow its business, and execute its growth strategies; the Company’s ability to effectively upgrade its information systems; the Company’s failure to perform its services in accordance with contractual requirements, regulatory standards, and ethical considerations; risks related to the management of clinical trials; risks related to investments in the Company’s customers’ businesses or drugs and the Company’s related commercial rights strategies; the need to hire, develop, and retain key personnel; the impact of unfavorable economic conditions, including the uncertain international economic environment, changes in exchange rates; effective income tax rate fluctuations; the Company’s ability to protect its intellectual property; risks related to the Company’s acquisition strategy, including its ability to realize synergies; the Company’s relationships with customers who are in competition with each other; any failure to realize the full value of the Company’s goodwill and intangible assets; risks related to restructuring; the Company’s compliance with anti-corruption and anti-bribery laws; the Company’s dependence on third parties; potential employment liability; the Company’s ability to utilize net operating loss carryforwards and other tax attributes; downgrades of the Company’s credit ratings; competition in the biopharmaceutical services industry; outsourcing trends and changes in aggregate spending and research and development budgets; the impact of, including changes in, government regulations and healthcare reform; the Company’s ability to keep pace with rapid technological change; the cost of and the Company’s ability to service its substantial indebtedness; other risks related to ownership of the Company’s common stock; and other risk factors set forth in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 as updated by the Company’s other SEC filings, copies of which are available free of charge on the Company’s website at investor.syneoshealth.com. The Company assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Use of Non-GAAP Financial Measures

In addition to the financial measures prepared in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”), this press release contains certain non-GAAP financial measures, including adjusted net income (including adjusted diluted earnings per share), EBITDA, adjusted EBITDA, and non-GAAP effective income tax rate. We also present revenue growth in constant currency. Constant currency revenue growth is defined as revenues for a given period restated at the comparative period’s foreign currency exchange rates measured against the comparative period’s revenues. Constant currency segment revenue growth is defined as revenue for a given period restated at the comparative period’s foreign currency exchange rates measured against the comparative period’s revenues.

A “non-GAAP financial measure” is generally defined as a numerical measure of a company’s financial performance that excludes or includes amounts from the most directly comparable measure calculated and presented in accordance with GAAP in the statements of operations, balance sheets, or statements of cash flows of the Company.

The Company defines adjusted net income (including adjusted diluted earnings per share) as net income (including diluted earnings per share) excluding acquisition-related amortization; restructuring and other costs; transaction and integration-related expenses; share-based compensation expense; gain or loss on extinguishment of debt; other income (expense), net; and the income tax effect of the above adjustments.

EBITDA represents earnings before interest, taxes, depreciation and amortization. The Company defines adjusted EBITDA as EBITDA, further adjusted to exclude expenses and transactions that the Company believes are not representative of its core operations, namely: restructuring and other costs; transaction and integration-related expenses; share-based compensation expense; other income (expense), net; and gain or loss on extinguishment of debt. The Company presents EBITDA and adjusted EBITDA because it believes they are useful metrics for investors as they are commonly used by investors, analysts and debt holders to measure the Company’s ability to fund capital expenditures and meet working capital requirements.

Each of the non-GAAP measures noted above are used by management and the Board to evaluate the Company’s core operating results because they exclude certain items whose fluctuations from period-to-period do not necessarily correspond to changes in the core operations of the business. Adjusted net income (including adjusted diluted earnings per share) and adjusted EBITDA are used by management and the Board to assess the performance of the Company’s business.

Non-GAAP measures have limitations in that they do not reflect all of the amounts associated with the Company’s results of operations as determined in accordance with GAAP. Also, other companies might calculate these measures differently. Investors are encouraged to review the reconciliations of the non-GAAP financial measures to their most directly comparable GAAP measures included in this press release and the accompanying tables.

Syneos Health, Inc. and Subsidiaries
Consolidated Statements of Operations
(in thousands, except per share data)
(Unaudited)

    Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
    2021     2020     2021     2020  
       
Revenue   $ 1,348,230     $ 1,099,004     $ 3,839,586     $ 3,275,758  
                                 
Costs and operating expenses:                                
Direct costs (exclusive of depreciation and amortization)     1,031,887       820,228       2,969,718       2,550,134  
Selling, general, and administrative expenses     139,524       118,051       421,507       351,942  
Restructuring and other costs     7,209       6,523       18,403       23,414  
Depreciation     17,680       17,301       54,285       51,830  
Amortization     38,574       38,147       117,618       115,746  
Total operating expenses     1,234,874       1,000,250       3,581,531       3,093,066  
Income from operations     113,356       98,754       258,055       182,692  
                                 
Total other expense, net:                                
Interest expense, net     16,774       20,442       62,650       68,126  
Loss on extinguishment of debt           346       2,802       346  
Other (income) expense, net     (3,827 )     10,596       (5,856 )     (2,573 )
Total other expense, net     12,947       31,384       59,596       65,899  
Income before provision for income taxes     100,409       67,370       198,459       116,793  
Income tax expense     22,166       3,954       39,587       15,892  
Net income   $ 78,243     $ 63,416     $ 158,872     $ 100,901  
                                 
Earnings per share:                                
Basic   $ 0.76     $ 0.61     $ 1.53     $ 0.97  
Diluted   $ 0.75     $ 0.60     $ 1.51     $ 0.96  
Weighted average common shares outstanding:                                
Basic     103,562       104,277       103,924       104,247  
Diluted     104,785       105,588       105,087       105,483  

Syneos Health, Inc. and Subsidiaries
Consolidated Balance Sheets
(in thousands, except par value)
(Unaudited)

    September 30, 2021     December 31, 2020  
ASSETS                
Current assets:                
Cash, cash equivalents, and restricted cash   $ 122,535     $ 272,173  
Accounts receivable and unbilled services, net     1,527,032       1,344,781  
Prepaid expenses and other current assets     114,632       121,058  
Total current assets     1,764,199       1,738,012  
Property and equipment, net     205,479       216,200  
Operating lease right-of-use assets     221,101       223,285  
Goodwill     4,896,907       4,776,178  
Intangible assets, net     880,847       933,525  
Deferred income tax assets     39,032       35,059  
Other long-term assets     209,394       141,047  
Total assets   $ 8,216,959     $ 8,063,306  
                 
LIABILITIES AND SHAREHOLDERS’ EQUITY                
Current liabilities:                
Accounts payable   $ 110,347     $ 113,684  
Accrued expenses     693,599       611,042  
Deferred revenue     819,903       793,068  
Current portion of operating lease obligations     45,842       42,082  
Current portion of finance lease obligations     18,580       17,455  
Total current liabilities     1,688,271       1,577,331  
Long-term debt     2,894,262       2,902,054  
Operating lease long-term obligations     215,907       221,760  
Finance lease long-term obligations     29,579       31,522  
Deferred income tax liabilities     7,532       20,216  
Other long-term liabilities     61,297       68,311  
Total liabilities     4,896,848       4,821,194  
                 
Commitments and contingencies                
                 
Shareholders’ equity:                
Preferred stock, $0.01 par value; 30,000 shares authorized, 0 shares issued and outstanding at September 30, 2021 and December 31, 2020            
Common stock, $0.01 par value; 600,000 shares authorized, 103,688 and 103,935 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively     1,037       1,039  
Additional paid-in capital     3,456,378       3,461,747  
Accumulated other comprehensive loss, net of taxes     (48,392 )     (40,801 )
Accumulated deficit     (88,912 )     (179,873 )
Total shareholders’ equity     3,320,111       3,242,112  
Total liabilities and shareholders’ equity   $ 8,216,959     $ 8,063,306  

Syneos Health, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(in thousands)
(Unaudited)

    Nine Months Ended
September 30,
 
    2021     2020  
Cash flows from operating activities:                
Net income   $ 158,872     $ 100,901  
Adjustments to reconcile net income to net cash provided by operating activities:                
Depreciation and amortization     171,903       167,576  
Share-based compensation     48,891       47,266  
Provision for doubtful accounts     51       1,357  
(Benefit from) provision for deferred income taxes     (21,324 )     21,306  
Foreign currency transaction gains     (6,320 )     (7,747 )
Fair value adjustment of contingent obligations     (597 )     (3,791 )
Loss on extinguishment of debt     2,802       346  
Other non-cash items     6,657       1,881  
Changes in operating assets and liabilities, net of effect of acquisitions:                
Accounts receivable, unbilled services, and deferred revenue     (154,162 )     15,542  
Accounts payable and accrued expenses     99,417       (2,226 )
Other assets and liabilities     (41,891 )     (31,244 )
Net cash provided by operating activities     264,299       311,167  
Cash flows from investing activities:                
Payments related to acquisitions of businesses, net of cash acquired     (226,347 )      
Proceeds from notes receivable from divestiture     5,000        
Purchases of property and equipment     (29,917 )     (38,493 )
Investments in unconsolidated affiliates     (5,074 )     (6,859 )
Loan to unconsolidated affiliate     (3,844 )      
Net cash used in investing activities     (260,182 )     (45,352 )
Cash flows from financing activities:                
Proceeds from issuance of long-term debt, net of discount     494,505        
Payments of debt financing costs     (544 )     (300 )
Repayments of long-term debt     (602,277 )     (113,750 )
Proceeds from accounts receivable financing agreement     65,000       31,600  
Repayments of accounts receivable financing agreement           (6,600 )
Proceeds from revolving line of credit     30,000       300,000  
Repayments of revolving line of credit           (300,000 )
Payments of contingent consideration related to acquisitions     (7,197 )     (26,634 )
Payments of finance leases     (12,748 )     (12,735 )
Payments for repurchases of common stock     (117,521 )     (62,029 )
Proceeds from exercises of stock options     26,223       22,973  
Payments related to tax withholdings for share-based compensation     (30,924 )     (20,701 )
Net cash used in financing activities     (155,483 )     (188,176 )
Effect of exchange rate changes on cash, cash equivalents, and restricted cash     1,728       7,568  
Net change in cash, cash equivalents, and restricted cash     (149,638 )     85,207  
Cash, cash equivalents, and restricted cash – beginning of period     272,173       163,689  
Cash, cash equivalents, and restricted cash – end of period   $ 122,535     $ 248,896  

Syneos Health, Inc. and Subsidiaries
Reconciliation of GAAP to Non-GAAP Measures
(in thousands)
(Unaudited)

    Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
    2021     2020     2021     2020  
EBITDA and adjusted EBITDA:                                
Net income, as reported   $ 78,243     $ 63,416     $ 158,872     $ 100,901  
Interest expense, net     16,774       20,442       62,650       68,126  
Income tax expense     22,166       3,954       39,587       15,892  
Depreciation     17,680       17,301       54,285       51,830  
Amortization (a)     38,574       38,147       117,618       115,746  
EBITDA     173,437       143,260       433,012       352,495  
Restructuring and other costs (b)     7,209       6,523       18,403       23,414  
Transaction and integration-related expenses (c)     10,679       6,955       31,099       17,900  
Share-based compensation (d)     15,099       15,093       48,891       47,266  
Other (income) expense, net (e)     (3,827 )     10,596       (5,856 )     (2,573 )
Loss on extinguishment of debt (f)           346       2,802       346  
Adjusted EBITDA   $ 202,597     $ 182,773     $ 528,351     $ 438,848  

Syneos Health, Inc. and Subsidiaries
Reconciliation of GAAP to Non-GAAP Measures
(in thousands, except per share data)
(Unaudited)

    Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
    2021     2020     2021     2020  
Adjusted net income:                                
Net income, as reported   $ 78,243     $ 63,416     $ 158,872     $ 100,901  
Amortization (a)     38,574       38,147       117,618       115,746  
Restructuring and other costs (b)     7,209       6,523       18,403       23,414  
Transaction and integration-related expenses (c)     10,679       6,955       31,099       17,900  
Share-based compensation (d)     15,099       15,093       48,891       47,266  
Other (income) expense, net (e)     (3,827 )     10,596       (5,856 )     (2,573 )
Loss on extinguishment of debt (f)           346       2,802       346  
Income tax adjustment to normalized rate (g)     (18,188 )     (30,853 )     (59,153 )     (60,642 )
Adjusted net income   $ 127,789     $ 110,223     $ 312,676     $ 242,358  
                                 
Diluted weighted average common shares outstanding     104,785       105,588       105,087       105,483  
                                 
Adjusted diluted earnings per share   $ 1.22     $ 1.04     $ 2.98     $ 2.30  
  1. Represents the amortization of intangible assets associated with acquired backlog, customer relationships, trade names and trademarks, and intellectual property.
  2. Restructuring and other costs consist primarily of severance costs associated with a reduction/optimization of our workforce in line with our expectations of future business operations and termination costs in connection with abandonment and closure of redundant facilities and other lease-related charges.
  3. Represents fees associated with acquisitions, stock repurchases and secondary stock offerings, debt placement and refinancings, and other corporate transactions costs.
  4. Represents non-cash share-based compensation expense related to awards granted under equity incentive plans.
  5. Other (income) expense is comprised primarily of foreign currency exchange gains and losses, other gains and losses related to investments, and contingent consideration on divested businesses.
  6. Loss on extinguishment of debt is associated with debt prepayments and refinancing activities.
  7. Represents the income tax effect of the non-GAAP adjustments made to arrive at adjusted net income using an estimated effective tax rate of approximately 24.0% for the three and nine months ended September 30, 2021 and September 30, 2020. These rates have been adjusted to exclude tax impacts related to valuation allowances recorded against deferred tax assets.

Syneos Health, Inc. and Subsidiaries
Reconciliation of GAAP to Non-GAAP
Full Year 2021 Guidance
(in millions, except per share data)
(Unaudited)

    Previous Guidance Issued
August 9, 2021
    Updated Guidance Issued
November 3, 2021
   
    Low     High     Low     High    
EBITDA and Adjusted EBITDA:                                  
GAAP net income   $ 206.6     $ 222.0     $ 228.9     $ 242.2    
Adjustments (a):                                  
Interest expense, net     84.0       87.0       80.0       80.0    
Income tax expense     88.6       95.2       81.2       85.9    
Depreciation     78.0       80.0       73.0       74.0    
Amortization     158.0       158.0       161.0       161.0    
EBITDA     615.2       642.2       624.1       643.1    
Restructuring and other costs     25.0       26.0       23.0       23.0    
Transaction and integration-related expenses     43.0       44.0       47.0       48.0    
Share-based compensation     66.0       67.0       64.0       64.0    
Other income, net     (2.0 )     (2.0 )     (5.9 )     (5.9 )  
Loss on extinguishment of debt     2.8       2.8       2.8       2.8    
Adjusted EBITDA   $ 750.0     $ 780.0     $ 755.0     $ 775.0    
    Previous Guidance issued August 9, 2021     Updated Guidance issued November 3, 2021    
    Adjusted
Net Income
    Adjusted Diluted
Earnings Per Share
    Adjusted
Net Income
    Adjusted Diluted
Earnings Per Share
   
    Low     High     Low     High     Low     High     Low     High    
Adjusted net income and adjusted diluted earnings per share:                                                                  
GAAP net income and diluted earnings per share   $ 206.6     $ 222.0     $ 1.96     $ 2.11     $ 228.9     $ 242.2     $ 2.18     $ 2.30    
Adjustments:                                                                  
Amortization (a)     158.0       158.0       1.50       1.50       161.0       161.0       1.53       1.53    
Restructuring and other costs (a)     25.0       26.0       0.24       0.25       23.0       23.0       0.22       0.22    
Transaction and integration-related expenses (a)     43.0       44.0       0.41       0.42       47.0       48.0       0.45       0.46    
Share-based compensation (a)     66.0       67.0       0.63       0.64       64.0       64.0       0.61       0.61    
Other income, net (a)     (2.0 )     (2.0 )     (0.02 )     (0.02 )     (5.9 )     (5.9 )     (0.06 )     (0.06 )  
Loss on extinguishment of debt (a)     2.8       2.8       0.03       0.03       2.8       2.8       0.03       0.03    
Income tax adjustment to normalized rate (b)     (52.6 )     (52.0 )     (0.50 )     (0.49 )     (63.2 )     (63.1 )     (0.60 )     (0.60 )  
Adjusted net income and adjusted diluted earnings per share (c)   $ 446.8     $ 465.8     $ 4.25     $ 4.43     $ 457.6     $ 472.0     $ 4.35     $ 4.49    
  1. Amounts are estimates with an estimated range of +/- 5% and are presented gross without the benefit of associated income tax deduction.
  2. Income tax expense is calculated and the adjustments are tax-affected at an approximate effective rate of 24.0%, which represents the Company’s estimated full year non-GAAP effective tax rate.
  3. Guidance for Adjusted Diluted EPS is based on an expectation of a fully diluted weighted average share count for the year ending December 31, 2021 of approximately 105.1 million shares, which will vary by quarter.

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Artificial Intelligence

Brainomix Achieves Breakthrough with FDA Clearance of e-Lung AI Software

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Established market leader in stroke AI imaging receives its first FDA clearance in the lung imaging space.With this expanded foundation of AI-driven healthcare solutions, the Oxford-based company remains committed to driving innovation and delivering impactful advancements in imaging biomarkers.OXFORD, England, and CHICAGO, May 17, 2024 /PRNewswire/ — Brainomix, a pioneer in artificial intelligence (AI) imaging solutions to enable precision medicine, is proud to announce the FDA clearance of its latest product, Brainomix 360 e-Lung. Brainomix’s entry into the lung imaging space follows a series of successful clearances and widespread clinical adoption of its Brainomix 360 Stroke platform in both the US and Europe.

The clearance of e-Lung marks a significant milestone in Brainomix’s journey to expand its footprint in medical imaging beyond stroke-related applications and represents a notable step forward in the quest for advanced lung imaging solutions. The company, with its rich academic heritage and record of scientific excellence, will expand its research collaborations in the pulmonology space to yield new insights to inform future iterations of e-Lung and chart a path towards continual improvements for the lung imaging technology.
Dr Deji Adegunsoye, Assistant Professor of Medicine and Scientific Director of the Interstitial Lung Disease Program at University of Chicago Medicine, said: “This is an exciting step for Brainomix, who have a demonstrated track record of developing novel AI-based solutions in stroke and are now applying that expertise to develop innovative tools in the lung space. The preliminary data for e-Lung is impressive and would indicate that we have a promising tool that could help to expedite healthcare delivery and improve clinically meaningful outcomes for patients with lung disease.”
Brainomix recently announced the publication of a new study1 in the prestigious peer-reviewed journal American Journal of Respiratory and Critical Care Medicine (AJRCCM), resulting from a research collaboration with AstraZeneca. The results showed that Brainomix’s proprietary lung imaging biomarkers, which include the weighted reticulovascular score (WRVS), stratified patients at risk of Idiopathic Pulmonary Fibrosis (IPF) progression, outperforming standard measures.
Dr Michalis Papadakis, CEO and Co-Founder of Brainomix, said: “We are harnessing our expertise in AI-powered imaging to develop novel biomarkers in other disease indications where AI can support imaging-based diagnostic and treatment decisions.
“This e-Lung FDA clearance reflects our focus on developing innovative solutions that empower healthcare professionals with cutting-edge tools for sophisticated disease evaluation, enhancing access to treatments that can ultimately work to improve patient outcomes.”
Brainomix will be presenting its latest e-Lung data at the American Thoracic Society (ATS) annual conference in San Diego May 17th – 22nd, including results from research collaborations with Heidelberg University and with Seattle-based Avalyn Pharma.
Am. J. Respir. Crit. Care Med.: 2024 Feb 16 – e-Lung CT Biomarker Stratifies Patients at Risk of IPF Progression in a 52-Week Clinical Trialhttps://www.atsjournals.org/doi/abs/10.1164/rccm.202312-2274LEAbout Brainomix
Brainomix specializes in the creation of AI-powered software solutions to enable precision medicine for better treatment decisions in stroke and lung fibrosis. With origins as a spin-out from the University of Oxford, Brainomix is an expanding commercial-stage company with offices in the UK, Ireland and the USA, and operations in more than 30 countries. A private company, backed by leading healthtech investors, Brainomix has innovated award-winning imaging biomarkers and software solutions that have been clinically adopted in hundreds of hospitals worldwide. Its first product, the Brainomix 360 stroke platform, provides clinicians with the most comprehensive stroke imaging solution, driving increased treatment rates and improving functional independence for patients.
To learn more about Brainomix and its technology visit www.brainomix.com, and follow us on Twitter, LinkedIn and Facebook.
Contacts
Jeff Wyrtzen, Chief Marketing & Business Development [email protected] +44 (0)7927 164210T +44 (0)1865 582730
Media enquiries
Charles ConsultantsSue [email protected] M +44 (0)7968 726585
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CUBE acquires global regulatory intelligence businesses from Thomson Reuters

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LONDON, May 17, 2024 /PRNewswire/ — CUBE, a global leader in Automated Regulatory Intelligence (ARI) and Regulatory Change Management (RCM), announces today its acquisition of the Thomson Reuters Regulatory Intelligence and Oden products and businesses.

The acquisition of these global businesses represents a major step forward in CUBE’s growth plans. It will deliver significant scale across many of the world’s leading and systemically important financial institutions. CUBE’s existing global customer base will be expanded to total approximately 1,000 customers in banking, insurance, asset and investment management, payments and adjacent regulated industries.
CUBE’s global employees will expand to 600, of which close to 250 are highly qualified regulatory subject matter experts, legal and compliance professionals.
Ben Richmond, founder and CEO of CUBE said: “Thomson Reuters is known to be the biggest and best in the industry for providing regulatory expert analysis and subject matter expertise, alongside world-leading journalism and news. The combination of CUBE’s purpose-built AI, with the years of content curated by Thomson Reuters Regulatory Intelligence and Oden expert analysts, will accelerate innovation. Together, we will deliver regulatory transformation capabilities for our global customers that could only have been imagined before.”
Richmond continues: “This combination will provide tremendous scale and depth across CUBE’s regulatory content and technology. It is a significant step toward creating an industry-defining regulatory compliance and risk platform that will benefit all customers and elevate the industry as a whole.”
Through this acquisition, CUBE will provide an expanded and comprehensive selection of specialized regulatory intelligence and regulatory change services, committed to excellence, quality, and highly contextualised and meaningful regulatory content for customers. By combining cutting-edge technology and subject matter expertise at scale CUBE will set a new bar for the industry in regulatory automation and content.
Chris Maguire, General Manager, Risk and Fraud, Corporates, Thomson Reuters said: “It was clear to us that CUBE had established itself as a leading regulatory intelligence provider for global enterprise clients in the financial services and insurance sectors. We wanted to ensure our customers and employees could work with an organisation that would continue to innovate and significantly invest in solutions like Thomson Reuters Regulatory Intelligence and Oden. We are working tirelessly to ensure a seamless and value-enhancing transition for customers and employees, and we are looking forward to working with the CUBE team during this transition.” 
Christopher Fielding, Hg, said: “We’re delighted to further extend our market reach, bringing in two high quality and complementary global businesses to the CUBE platform.”
Thomas Martin, Hg, added: “We see these acquisitions as enabling further innovation in the regulatory intelligence and change management sector, leading to strengthened demand for these quality solutions across the globe.”
The terms of the transaction will not be disclosed.
About CUBE
CUBE provides a highly comprehensive and robust source of classified, and meaningful AI-driven regulatory data to power its Automated Regulatory Intelligence (ARI) and Regulatory Change Management (RCM) solutions. CUBE’s purpose-built regulatory technology including its AI engine (RegBrain) and software platform (RegPlatform) tracks, analyses, and monitors laws, rules, and regulations in every country and in every published language to create an always up-to-date regulatory footprint that transforms visibility and compliance capability for customers across the globe.
With operations across Europe, North America, Canada, Asia, and Australia, CUBE serves a diverse and global base of customers and partners including the largest financial institutions in the world who leverage CUBE’s platform to streamline their complex regulatory intelligence and change management processes.
Following the strategic partnership with Hg in March 2024, CUBE announced the acquisition of US-based Reg-Room in May 2024.
About Hg
Hg supports the building of sector-leading enterprises that supply businesses with critical software applications or workflow services, delivering a more automated workplace for their customers.
This industry is characterised by digitisation trends that are in early stages of adoption and are set to transform the workplace for professionals over decades to come. Hg’s support combines deep end-market knowledge with world class operational resources, together providing compelling support to entrepreneurial leaders looking to scale their business – businesses that are well invested, enduring and serve their customers well.
With a vast European network and strong presence across North America, Hg’s 400 employees and around $70 billion in funds under management support a portfolio of around 50 businesses, worth over $140 billion aggregate enterprise value, with over 110,000 employees, consistently growing revenues at more than 20%.
About Regulatory Intelligence
Regulatory Intelligence is a proactive, connected, and comprehensive solution that tracks and analyses regulatory changes within ~2,000 regulatory bodies and rulebooks for more than 20 countries. It enables banking, financial services, and insurance (BFSI) sectors to manage exposure to operational, regulatory, and compliance risk.
About Oden
Oden State Rules and Regulations (SR&R), Oden Policy Terminator/Sentry PT, and OdenTrack provide repositories and automated solutions for complying with state rules and regulations on the provisioning of Personal and Business Insurance in the US.

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Cayman Enterprise City Publishes Socio-Economic Impact Assessment by Economist and Leading Advisor on the Caribbean, Marla Dukharan

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The Impact of Cayman Enterprise City’s Socio-Economic Development Project Nears USD $1 Billion
GRAND CAYMAN, Cayman Islands, May 16, 2024 /PRNewswire/ — Cayman Enterprise City (CEC) has released a Socio-Economic Impact Assessment by Marla Dukharan. The report illustrates that CEC is increasing its impact by supporting higher earnings for Caymanians and is driving a shift towards a knowledge-based economy by focusing on high productivity sectors. The release by Dukharan reads, “Caymanian resourcefulness and private sector-led innovation have been the driving force behind the islands’ outstanding socio-economic success. Cayman Enterprise City underpins the next generation of Cayman innovation and dynamism.”

With an economic impact of USD $130 million in 2023, contributing just under USD $1 billion to the local economic activity in 12 years since inception, “CEC is helping the nation to diversify economically, in terms of sectors and jobs, ensuring locals have economic and employment opportunities that match the nation’s progress,” the report reads.
The CEC socio-economic development project is now home to 352 Special Economic Zones Companies (SEZCos), many of which are globally recognised institutions led by top executives and industry experts. “CEC member companies are providing high-value employment with salaries exceeding those typically found outside of the special economic zone,” said Charlie Kirkconnell, Chief Executive Officer at CEC. “The CEC community is fully invested in Cayman and the report illustrates that the CEC socio-economic development project is making a very significant impact on Cayman’s economy and community.”
“As CEC continues to grow, it continues to create significant employment and entrepreneurial opportunities for Caymanians and we encourage anyone that might be interested in finding out how they might get involved, whether as a member of the community and/or as a volunteer in our Enterprise Cayman non-profit organisation (NPO).”
77% of Caymanian-held jobs at CEC member companies, are in sectors with high social returns and increasing global demand. “By putting skills first and prioritizing learning, CEC is enabling new industries to take root,” the release by Dukharan reads.
CEC, through its Enterprise Cayman NPO, is a first-mover in private sector-facilitated education and training in the Caribbean, making it a leading force to boost youth participation in the economy. By offering training in specialised skills, Enterprise Cayman is helping to close the gap in higher education and earnings for Caymanians. “Through Enterprise Cayman we’ve set out to strategically support meaningful employment and entrepreneurial opportunities for Caymanians, by providing internship and mentorship opportunities, by hosting skill-building and career focused training, and by providing invaluable networking and community engagement opportunities,” said Kirkconnell.
In 2023 individuals took advantage of 4,226 opportunities to participate in education, training, and career development events and, since launching entrepreneurial programming in 2021, Enterprise Cayman has worked with 41 new Cayman-born business ventures. “We’re helping to develop a local talent pool that meets the demand of Cayman’s growing digital innovation and technology sectors while, in parallel, offering exciting opportunities for individuals to launch new business ventures within an innovative business environment,” said Kirkconnell.  
With CEC’s new campus and state-of-the-art facilities, Signal House, the project “holds the promise of deep, continued economic impact,” the report concludes.
To access CEC’s economic impact assessments and Enterprise Cayman’s annual reports please visit https://www.enterprisecayman.ky/reports. For more information on how to get involved and for upcoming programmes and events visit www.enterprisecayman.ky. 
Website: www.caymanenterprisecity.com LinkedIn: @CaymanEnterpriseCityTwitter:  @CEC_CaymanInstagram: @CaymanEnterpriseCityFacebook: @CaymanEnterpriseCityYouTube: @ceccayman
About Cayman Enterprise City 
Cayman Enterprise City (CEC) is an award-winning development project which consists of three special economic zones (SEZs) focused on attracting knowledge-based and specialised-services businesses to set up a genuine physical presence in the Cayman Islands. The zones included within CEC are Cayman Tech City, Cayman Commodities & Derivatives Centre, and Cayman Maritime & Aviation City. With a dedicated Government Authority, licensing fee concessions and guaranteed fast-track processes, CEC enables international companies to quickly and efficiently establish a Cayman Islands office, which in turn enables them to generate active business income within a tax neutral environment.
About Enterprise Cayman 
Enterprise Cayman is a non-profit organisation (NPO) powered by Cayman Enterprise City in partnership with Cayman Islands’ special economic zone companies (SEZCos). The organisation, which applies the Theory of Change (TOC) methodology, provides Caymanians and residents with access to high-quality learning experiences and opportunities to develop and launch new business ventures, to pursue careers within the technology and innovation sectors, and to join a dynamic network of industry professionals. Let’s grow the next generation of Caymanian innovators and entrepreneurs with Enterprise Cayman!
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FOR MORE INFORMATION:Contact: Kaitlyn Elphinstone  Email: [email protected]  

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