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C4 Therapeutics

ZimVie Reports Fourth Quarter and Full Year 2022 Financial Results

March 01, 2023 | Last Trade: US$13.39 0.39 -2.83
  • FY 2022 Third Party Net Sales of $909.5 million
  • FY 2022 Net Loss of ($63.9) million; Net Loss Margin of (7.0%); Adjusted Net Income[1] of $47.9 million
  • FY 2022 Diluted EPS of ($2.45); Adjusted Diluted EPS[1] of $1.84
  • FY 2022 Adjusted EBITDA[1] of $122.5 million; Adjusted EBITDA margin[1] of 13.5%

WESTMINSTER, Colo., March 01, 2023 (GLOBE NEWSWIRE) -- ZimVie Inc. (Nasdaq: ZIMV), a global life sciences leader in the dental and spine markets, today reported financial results for the fourth quarter and full year ended December 31, 2022. Management will host a corresponding conference call today, March 1, 2023, at 4:30 p.m. Eastern Time.

“Our team has been diligently focused on accelerating independence from our prior parent, and despite a difficult macroenvironment, we launched several innovative products and drove significant operational progress in our first year as a company. We remain focused on innovating around our core platforms and driving adoption of our clinically differentiated solutions,” said Vafa Jamali, President and Chief Executive Officer of ZimVie.

Recent Business Highlights

  • Launched T3® PRO Tapered Implant, Next-Generation TSX™ Implant, and Encode® Emergence Healing Abutment designed to optimize restorative care and aesthetics
  • Launched RealGUIDE™ CAD and FULL SUITE software modules enhancing digital dentistry platform
  • Surpassed 200,000 Mobi-C implants worldwide
  • Received positive policy decision from Highmark applicable to The Tether™, ZimVie’s differentiated, non-fusion spinal device for the treatment of idiopathic scoliosis, expanding coverage to 4+ million lives and following a positive policy decision from Anthem in mid-2022
  • Signed a partnership and global development agreement with Brainlab AG. to integrate minimally invasive Vital™ and Virage™ systems and Brainlab AG.’s industry leading portfolio of spine imaging, planning, navigation, and robotic assisted solutions

Recent Operational Highlights

  • Successfully completed 3 ERP conversions
  • Refreshed core IT systems, including successful transition of over 230 applications
  • Exited, downsized, or transformed 5 facilities worldwide
  • Reduced excess inventory to improve cash on hand
  • Paid all 2023 debt principal payments in advance as part of ongoing initiative to reduce leverage  

Fourth Quarter 2022 Financial Results

Third party net sales for the fourth quarter of 2022 were $228.2 million, a decrease of (12.4%) on a reported basis and (9.1%) on a constant currency[1] basis, versus the fourth quarter of 2021. Third party dental segment net sales of $115.8 million decreased by ($9.6) million, or (7.6%) on a reported basis and (2.9%) on a constant currency[1] basis, driven by a general slowdown of customer purchases due to macroeconomic pressures and in anticipation of volume-based procurement (“VBP”) in China. Third party spine segment net sales of $112.3 million decreased by ($22.9) million, or (16.9%) on a reported basis and (14.8%) in constant currency[1], driven by the exit of a number of unprofitable markets in late 2021, the discontinuation of certain products and brands, a slowdown of customer purchases in China in anticipation of VBP, operational disruptions resulting from an ERP implementation, other IT systems projects, and continued competitive pressures in the spine market. Both segments were unfavorably impacted by one less selling day in the fourth quarter of 2022.

Net loss for the fourth quarter of 2022 was ($30.3) million, a decrease of $30.3 million versus the net loss of ($60.7) million in the fourth quarter of 2021, and as a percentage of third-party net sales was (13.3%). The decrease in net loss was primarily due to prior year brand rationalization charges that did not recur, lower inventory charges and lower SG&A costs due to lower variable selling costs on lower net sales as well as cost savings initiatives, partially offset by the net loss impact associated with the revenue declines noted above. Adjusted net income[1] for the fourth quarter of 2022 was $4.3 million, an increase of $13.6 million versus the same prior year period.

Basic and diluted EPS were ($1.16) and adjusted diluted EPS[1] was $0.16 for the fourth quarter of 2022. Weighted average shares outstanding for basic and diluted EPS was 26.1 million.

Adjusted EBITDA[1] for the fourth quarter of 2022 was $28.1 million, or 12.3%, a 70 basis point increase from the fourth quarter of 2021.

Cash and cash equivalents at the end of the fourth quarter of 2022 were $89.6 million and reflect the advanced payment in 2022 of the 2023 required principal payments under our credit agreement.

Full Year 2022 Financial Results

Third party net sales for the full year 2022 were $909.5 million, a decrease of (9.8%) on a reported basis and (6.8%) on a constant currency[1] basis, versus the full year 2021. Third party dental segment net sales of $459.7 million decreased by ($8.8) million, or (1.9%) on a reported basis but increased 2.6% on a constant currency[1] basis. Third party spine segment net sales of $449.8 million decreased by ($90.5) million, or (16.8%) on a reported basis and (14.9%) on a constant currency[1] basis, driven by the exit of a number of unprofitable markets in late 2021, the discontinuation of certain products and brands, the impact of the third party net sales retained by Zimmer Biomet Holdings, Inc. (“Zimmer Biomet”) until we completed our separation activities in certain markets at the end of the third quarter of 2022, distributor bulk orders in the first quarter of 2021 that did not recur, the surge in COVID-19 cases in the first half of 2022 related to the Omicron variant, a slowdown of customer purchases in China in anticipation of VBP, operational disruptions resulting from an ERP implementation and other IT systems projects, continued competitive pressures in the spine market and changes in foreign currency exchange rates.

Net loss for the full year 2022 was ($63.9) million, a decrease of $31.4 million versus the net loss of ($95.3) million in the full year 2021, and as a percentage of third-party net sales was (7.0%). The decrease in net loss was primarily due to prior year brand rationalization charges that did not recur, lower inventory charges and lower SG&A costs due to lower variable selling costs on lower net sales as well as cost savings initiatives, partially offset by the decline in spine third party net sales. Adjusted net income[1] for the full year 2022 was $47.9 million, an increase of $10.8 million versus the prior year.

Basic and diluted EPS were ($2.45) and adjusted diluted EPS[1] was $1.84 for the full year 2022. Weighted average shares outstanding for basic EPS and diluted EPS was 26.1 million.

Adjusted EBITDA[1] for the full year 2022 was $122.5 million, or 13.5% of third-party net sales, a decrease of ($9.1) million but an expansion of 50 basis points from 13.0% in 2021.

Full Year 2023 Financial Guidance:

Projected Year Ending December 31, 2023
Reported Net Sales$825M - $850M
Adjusted EBITDA Margin[2]13.5% to 14.0%
Adjusted EPS[2]$0.30 - $0.50

[1] This is a non-GAAP financial measure. Refer to “Note on Non-GAAP Financial Measures” and the reconciliations in this release for further information.

[2] This is a non-GAAP financial measure for which a reconciliation to the most directly comparable GAAP financial measure is not available without unreasonable efforts. Refer to “Forward-Looking Non-GAAP Financial Measures” in this release, which identifies the information that is unavailable without unreasonable efforts and provides additional information. It is probable that this forward-looking non-GAAP financial measure may be materially different from the corresponding GAAP financial measure.

Financial Information

The financial information included in this release for periods prior to March 1, 2022 is derived from the financial statements and records of the dental and spine businesses of Zimmer Biomet due to the fact that during such periods, ZimVie was still a wholly-owned subsidiary of, and operated under those businesses of, Zimmer Biomet.

Conference Call

ZimVie will host a conference call today, March 1, 2023, at 4:30 p.m. ET to discuss its fourth quarter and full-year 2022 financial results. To access the call, please register online at https://investor.zimvie.com/events-presentations/event-calendar. A live and archived audio webcast will also be available on this site.

About ZimVie

ZimVie is a global life sciences leader in the dental and spine markets that develops, manufactures, and delivers a comprehensive portfolio of products and solutions designed to support dental tooth replacement and restoration procedures and treat a wide range of spine pathologies. In March 2022 the company became an independent, publicly traded spin-off of the dental and spine business units of Zimmer Biomet to breathe new life, dedicated energy, and strategic focus to its portfolio of trusted brands and products. From its headquarters in Westminster, Colorado, and additional facilities around the globe, the company serves customers in over 70 countries worldwide with a robust offering of dental and spine solutions including differentiated product platforms supported by extensive clinical evidence. For more information about ZimVie, please visit us at www.ZimVie.com. Follow @ZimVie on Twitter, Facebook, LinkedIn, or Instagram.

Note on Non-GAAP Financial Measures

This press release includes non-GAAP financial measures that differ from financial measures calculated in accordance with U.S. generally accepted accounting principles (“GAAP”). These non-GAAP financial measures may not be comparable to similar measures reported by other companies and should be considered in addition to, and not as a substitute for, or superior to, other measures prepared in accordance with GAAP.

Adjusted EBITDA is a non-GAAP financial measure provided in this release for certain periods, and is calculated by excluding certain items from net income (loss) on a GAAP basis, as detailed in the reconciliations presented later in this press release. Adjusted EBITDA margin is Adjusted EBITDA divided by third party net sales for the applicable period.

Sales change information in this release is presented on a GAAP (reported) basis and on a constant currency basis. Constant currency percentage changes exclude the effects of foreign currency exchange rates. They are calculated by translating current and prior-period sales at the same predetermined exchange rate. The translated results are then used to determine year-over-year percentage increases or decreases.

Net income (loss) and diluted earnings (loss) per share in this release are presented on a GAAP (reported) basis and on an adjusted basis. Adjusted net income (loss) and adjusted diluted earnings per share exclude the effects of certain items, which are detailed in the reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures presented later in this press release.

Reconciliations of these non-GAAP measures to the most directly comparable GAAP financial measures are included in this press release.

Management uses non-GAAP financial measures internally to evaluate the performance of the business. Additionally, management believes these non-GAAP measures provide meaningful incremental information to investors to consider when evaluating the performance of the company. Management believes these measures offer the ability to make period-to-period comparisons that are not impacted by certain items that can cause dramatic changes in reported income but that do not impact the fundamentals of our operations. The non-GAAP measures enable the evaluation of operating results and trend analysis by allowing a reader to better identify operating trends that may otherwise be masked or distorted by these types of items that are excluded from the non-GAAP measures.

Forward-Looking Non-GAAP Financial Measures

This press release also includes certain forward-looking non-GAAP financial measures for the year ending December 31, 2023. We calculate forward-looking non-GAAP financial measures based on internal forecasts that omit certain amounts that would be included in GAAP financial measures. We have not provided quantitative reconciliations of these forward-looking non-GAAP financial measures to the most directly comparable forward-looking GAAP financial measures because the excluded items are not available on a prospective basis without unreasonable efforts. For example, the timing of certain transactions is difficult to predict because management’s plans may change. In addition, the company believes such reconciliations would imply a degree of precision and certainty that could be confusing to investors. It is probable that these forward-looking non-GAAP financial measures may be materially different from the corresponding GAAP financial measures.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including, among others, any statements about our expectations, plans, intentions, strategies, or prospects. We generally use the words “may,” “will,” “expects,” “believes,” “anticipates,” “plans,” “estimates,” “projects,” “assumes,” “guides,” “targets,” “forecasts,” “sees,” “seeks,” “should,” “could,” “would,” “predicts,” “potential,” “strategy,” “future,” “opportunity,” “work toward,” “intends,” “guidance,” “confidence,” “positioned,” “design,” “strive,” “continue,” “track,” “look forward to” and similar expressions to identify forward-looking statements. All statements other than statements of historical or current fact are, or may be deemed to be forward-looking statements. Such statements are based upon the current beliefs, expectations, and assumptions of management and are subject to significant risks, uncertainties, and changes in circumstances that could cause actual outcomes and results to differ materially from the forward-looking statements. These risks, uncertainties and changes in circumstances include, but are not limited to: the effects of the COVID-19 global pandemic and other adverse public health developments on the global economy, our business and operations and the business and operations of our suppliers and customers, including the deferral of elective procedures and our ability to collect accounts receivable; dependence on new product development, technological advances and innovation; shifts in the product category or regional sales mix of our products and services; supply and prices of raw materials and products; pricing pressures from competitors, customers, dental practices and insurance providers; changes in customer demand for our products and services caused by demographic changes or other factors; challenges relating to changes in and compliance with governmental laws and regulations affecting our U.S. and international businesses, including regulations of the U.S. Food and Drug Administration and foreign government regulators, such as more stringent requirements for regulatory clearance of products; competition; the impact of healthcare reform measures; reductions in reimbursement levels by third-party payors; cost containment efforts sponsored by government agencies, legislative bodies, the private sector and healthcare group purchasing organizations, including the volume-based procurement process in China; control of costs and expenses; dependence on a limited number of suppliers for key raw materials and outsourced activities; the ability to obtain and maintain adequate intellectual property protection; breaches or failures of our information technology systems or products, including by cyberattack, unauthorized access or theft; the ability to retain the independent agents and distributors who market our products; our ability to attract, retain and develop the highly skilled employees we need to support our business; the effect of mergers and acquisitions on our relationships with customers, suppliers and lenders and on our operating results and businesses generally; a determination by the Internal Revenue Service that the distribution or certain related transactions should be treated as taxable transactions; financing transactions undertaken in connection with the separation and risks associated with additional indebtedness; the impact of the separation on our businesses and the risk that the separation and the results thereof may be more difficult, time-consuming and/or costly than expected, which could impact our relationships with customers, suppliers, employees and other business counterparties; restrictions on activities following the distribution in order to preserve the tax-free treatment of the distribution; the ability to form and implement alliances; changes in tax obligations arising from tax reform measures, including European Union rules on state aid, or examinations by tax authorities; product liability, intellectual property and commercial litigation losses; changes in general industry and market conditions, including domestic and international growth rates; changes in general domestic and international economic conditions, including inflation and interest rate and currency exchange rate fluctuations; and the impact of the ongoing financial and political uncertainty on countries in the Euro zone on the ability to collect accounts receivable in affected countries. You are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate. Forward-looking statements speak only as of the date they are made, and we expressly disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Media Contact Information:

ZimVie
Laura Driscoll • This email address is being protected from spambots. You need JavaScript enabled to view it.
(774) 284-1606

Investor Contact Information:

Gilmartin Group LLC
Marissa Bych • This email address is being protected from spambots. You need JavaScript enabled to view it.

ZIMVIE INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)

  For the Three Months Ended December 31, For the Twelve Months Ended December 31,
  2022 2021  2022 2021 
Net Sales      
Third party, net 228,164 260,596  909,487 1,008,830 
Related party, net 956 977  4,375 5,819 
Total Net Sales 229,120 261,573  913,862 1,014,649 
Cost of products sold, excluding intangible asset amortization (73,347)(125,172) (296,679)(381,569)
Related party cost of products sold, excluding intangible asset amortization (930)(742) (4,107)(4,248)
Intangible asset amortization (20,689)(21,178) (80,867)(86,219)
Research and development (15,254)(17,399) (62,691)(61,328)
Selling, general and administrative (134,461)(149,312) (523,970)(554,377)
Restructuring (4,868)(1,053) (11,354)(3,344)
Acquisition, integration, divestiture and related (3,982)(12,053) (29,437)(24,064)
Operating expenses (253,531)(326,909) (1,009,105)(1,115,149)
Operating Loss (24,411)(65,336) (95,243)(100,500)
Other income (expense), net 2,626 (73) 3,603 (465)
Interest expense, net (6,432)16  (18,279)(292)
Loss before income taxes (28,217)(65,393) (109,919)(101,257)
Benefit for income taxes (2,127)4,702  46,038 6,003 
Net Loss (30,344)(60,691) (63,881)(95,254)
Loss Per Common Share - Basic (1.16)(2.33) (2.45)(3.66)
Loss Per Common Share - Diluted (1.16)(2.33) (2.45)(3.66)


ZIMVIE INC.

CONSOLIDATED BALANCE SHEETS
(in thousands, except per share data)

  As of December 31, 
  2022  2021 
ASSETS      
Current Assets:      
Cash and cash equivalents $89,601  $100,399 
Accounts receivable, less allowance for credit losses  168,961   164,241 
Related party receivable  8,483    
Inventories  233,854   246,832 
Prepaid expenses and other current assets  36,964   25,380 
Total Current Assets  537,863   536,852 
Property, plant and equipment, net  148,439   180,243 
Goodwill  259,999   267,810 
Intangible assets, net  654,965   766,175 
Other assets  40,790   75,656 
Total Assets $1,642,056  $1,826,736 
LIABILITIES AND EQUITY      
Current Liabilities:      
Accounts payable $43,998  $45,026 
Related party payable  13,176    
Income taxes payable  14,356   6,278 
Other current liabilities  145,779   133,280 
Total Current Liabilities  217,309   184,584 
Deferred income taxes, net  98,062   129,475 
Lease liability  22,287   45,317 
Other long-term liabilities  13,561   15,983 
Non-current portion of debt  532,233    
Total Liabilities  883,452   375,359 
Stockholders' Equity:      
Common stock, $0.01 par value, 150,000 shares authorized
Shares, issued and outstanding, of 26,222 and 0, respectively
  262    
Preferred stock, $0.01 par value, 15,000 shares authorized, 0 shares issued and outstanding      
Additional paid in capital  897,028    
Accumulated deficit  (47,532)   
Net parent company investment     1,494,157 
Accumulated other comprehensive loss  (91,154)  (42,780)
Total Stockholders' Equity  758,604   1,451,377 
Total Liabilities and Stockholders' Equity $1,642,056  $1,826,736 

The accompanying notes are an integral part of these consolidated financial statements.

ZIMVIE INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)

  For the Years Ended December 31, 
  2022  2021  2020 
Cash flows provided by operating activities:         
Net loss $(63,881) $(95,254) $(178,999)
Adjustments to reconcile net loss to net cash provided by operating
activities:
         
Depreciation and amortization  122,789   129,719   134,331 
Goodwill impairment        142,000 
Share-based compensation  30,289   7,309   5,945 
Deferred income tax provision  (70,422)  (22,089)  (22,806)
Loss on disposal of fixed assets  3,358       
Other non-cash items  1,172       
Changes in operating assets and liabilities, net of acquired assets
and liabilities
         
Income taxes  5,485   (3,201)  904 
Accounts receivable  (26,156)  27,172   (1,072)
Related party receivables  (8,483)      
Inventories  10,210   33,062   (6,141)
Accounts payable and accrued liabilities  21,842   (6,591)  (3,030)
Related party payables  13,176       
Other assets and liabilities  (14,751)  (5,842)  14,848 
Net cash provided by operating activities  24,628   64,285   85,980 
Cash flows used in investing activities:         
Additions to instruments  (10,089)  (28,244)  (32,699)
Additions to other property, plant and equipment  (16,457)  (28,405)  (5,568)
Business combination investments, net of acquired cash        (8,415)
Other investing activities  (2,117)  (3,700)  (2,832)
Net cash used in investing activities  (28,663)  (60,349)  (49,514)
Cash flows provided by (used in) financing activities:         
Net transactions with Zimmer Biomet Holdings, Inc  6,920   90,006   (43,830)
Dividend paid to Zimmer Biomet Holdings, Inc  (540,567)      
Proceeds from term loans  595,000       
Payments on term loans  (58,544)      
Debt issuance costs  (5,170)      
Net cash flows from unremitted collections from factoring programs        (1,626)
Repayments of debt due to Zimmer Biomet Holdings, Inc     (16,905)  (668)
Net activity under employee stock compensation plans  1,059       
Other financing activities  (5)  (752)  (359)
Net cash (used in) provided by financing activities  (1,307)  72,349   (46,483)
Effect of exchange rates on cash and cash equivalents  (5,456)  (3,305)  435 
(Decrease) increase in cash and cash equivalents  (10,798)  72,980   (9,582)
Cash and cash equivalents, beginning of year  100,399   27,419   37,001 
Cash and cash equivalents, end of period $89,601   100,399   27,419 
             
Supplemental cash flow information:         
Income taxes paid, net $25,730  $12,089  $4,654 
Interest paid  17,283       
Non-cash settlement of debt due to parent     4,939    
Supplemental schedule of noncash investing and financing activities:         
Derecognition of right-of-use assets $(14,174) $  $ 
Derecognition of lease liabilities  15,303       
          

The accompanying notes are an integral part of these consolidated financial statements.

SUPPLEMENTAL FINANCIAL INFORMATION AND NON-GAAP FINANCIAL MEASURES (UNAUDITED)

Total Net Sales by Segment and Region (in thousands)

  For the Three Months Ended December 31,    
   2022  2021 Change (%) Foreign Exchange ImpactConstant Currency % Change
United States $67,535 $69,496 -2.8% - -2.8%
International  48,308  55,911 -13.6% -10.7%-2.9%
Total Dental Net Sales  115,843  125,407 -7.6% -4.7%-2.9%
United States  90,853  101,200 -10.2% - -10.2%
International  21,468  33,989 -36.8% -8.3%-28.5%
Total Spine Net Sales  112,321  135,189 -16.9% -2.1%-14.8%
Total Third Party Net Sales  228,164  260,596 -12.4% -3.3%-9.1%
Related Party Net Sales  956  977 -2.1% - - 
Total Net Sales $229,120 $261,573 -12.4% -3.4%-9.0%

 

  For the Twelve Months Ended December 31,    
   2022  2021 Change (%) Foreign Exchange ImpactConstant Currency % Change
United States $272,726 $267,689 1.9% - 1.9%
International  186,955  200,793 -6.9% -10.4%3.5%
Total Dental Net Sales  459,681  468,482 -1.9% -4.5%2.6%
United States  357,416  407,883 -12.4% - -12.4%
International  92,390  132,465 -30.3% -7.6%-22.7%
Total Spine Net Sales  449,806  540,348 -16.8% -1.9%-14.9%
Total Third Party Net Sales  909,487  1,008,830 -9.8% -3.0%-6.8%
Related Party Net Sales  4,375  5,819 -24.8% - - 
Total Net Sales $913,862 $1,014,649 -9.9% -3.2%-6.7%

Reconciliation of Adjusted Net Income (Loss) and Adjusted EPS (in thousands, except per share data)

 For the Three Months Ended December 31, 2022
       
 Net SalesCost of products
sold, excluding
intangible asset
amortization
Operating
expenses,
excluding cost of
products sold
Operating
Income
(Loss)
Net Income
(Loss)
Diluted
EPS
Reported$229,120 $(74,277)$(179,254)$(24,411)$(30,344)$(1.16)
Pre vs. post-spin cost structure differences[1] -  -  -  -  - $- 
Restructuring[2] -  -  4,868  4,868  4,868 $0.19 
Acquisition, integration, divestiture and related[3] -  -  3,982  3,982  3,982 $0.15 
European medical device regulation[4] -  -  3,510  3,510  3,510 $0.13 
One-time carve-out allocations and other one-time costs[5] -  1,875  -  1,875  1,875 $0.07 
Intangible asset amortization -  -  20,689  20,689  20,689 $0.79 
Related party (956) 930  -  (26) (26)$- 
One-time share-based compensation expense[6] -  -  1,000  1,000  1,000 $0.04 
Tax effect of above adjustments -  -  -  -  (1,287)$(0.05)
Favorable Puerto Rico tax ruling[7] -  -  -  -  - $- 
Adjusted$228,164 $(71,472)$(145,205)$11,487 $4,267 $0.16 
       
 For the Three Months Ended December 31, 2021
       
 Net SalesCost of products
sold, excluding
intangible asset
amortization
Operating
expenses,
excluding cost of
products sold
Operating
Income
(Loss)
Net Income
(Loss)
Diluted
EPS
Reported$261,573 $(125,914)$(200,995)$(65,336)$(60,691)$(2.33)
Pre vs. post-spin cost structure differences[1] -  -  3,027  3,027  3,027 $0.12 
Restructuring[2] -  -  1,053  1,053  1,053 $0.04 
Acquisition, integration, divestiture and related[3] -  -  12,053  12,053  12,053 $0.46 
European medical device regulation[4] -  -  3,092  3,092  3,092 $0.12 
One-time carve-out allocations and other one-time costs[5] -  31,794  8,365  40,159  40,159 $1.54 
Intangible asset amortization -  -  21,178  21,178  21,178 $0.81 
Related party (977) 742  110  (125) (125)$- 
One-time share-based compensation expense[6] -  -  -  -  - $- 
Tax effect of above adjustments -  -  -  -  (29,117)$(1.12)
Favorable Puerto Rico tax ruling[7] -  -  -  -  - $- 
Adjusted$260,596 $(93,378)$(152,117)$15,101 $(9,371)$(0.36)

Reconciliation of Adjusted Net Income and Adjusted EPS (in thousands, except per share data)

 For the Twelve Months Ended December 31, 2022
  
 Net SalesCost of products
sold, excluding
intangible asset
amortization
Operating
expenses,
excluding cost of
products sold
Operating
Income
(Loss)
Net Income
(Loss)
Diluted
EPS
Reported$913,862 $(300,786)$(708,319)$(95,243)$(63,881)$(2.45)
Pre vs. post-spin cost structure differences[1] -  -  5,271  5,271  5,271 $0.20 
Restructuring[2] -  -  11,354  11,354  11,354 $0.44 
Acquisition, integration, divestiture and related[3] -  -  29,437  29,437  29,437 $1.13 
European medical device regulation[4] -  -  10,064  10,064  10,064 $0.39 
One-time carve-out allocations and other one-time costs[5] -  (164) 4,890  4,726  4,726 $0.18 
Intangible asset amortization -  -  80,867  80,867  80,867 $3.10 
Related party (4,375) 4,107  -  (268) (268)$(0.01)
One-time share-based compensation expense[6] -  1,664  12,981  14,645  14,645 $0.56 
Tax effect of above adjustments -  -  -  -  (38,639)$(1.48)
Favorable Puerto Rico tax ruling[7] -  -  -  -  (5,712)$(0.22)
Adjusted$909,487 $(295,179)$(553,455)$60,853 $47,864 $1.84 
       
 For the Twelve Months Ended December 31, 2021
       
 Net SalesCost of products
sold, excluding
intangible asset
amortization
Operating
expenses,
excluding cost of
products sold
Operating
Income
(Loss)
Net Income
(Loss)
Diluted
EPS
Reported$1,014,649 $(385,817)$(729,332)$(100,500)$(95,254)$(3.66)
Pre vs. post-spin cost structure differences[1] -  -  7,439  7,439  7,439 $0.29 
Restructuring[2] -  -  3,344  3,344  3,344 $0.13 
Acquisition, integration, divestiture and related[3] -  -  24,064  24,064  24,064 $0.92 
European medical device regulation[4] -  -  5,627  5,627  5,627 $0.22 
One-time carve-out allocations and other one-time costs[5] -  37,356  15,300  52,656  52,656 $2.02 
Intangible asset amortization -  -  86,219  86,219  86,219 $3.31 
Related party (5,819) 4,248  317  (1,254) (1,254)$(0.05)
One-time share-based compensation expense[6] -  -  -  -  - $- 
Tax effect of above adjustments -  -  -  -  (45,806)$(1.76)
Favorable Puerto Rico tax ruling[7] -  -  -  -  - $- 
Adjusted$1,008,830 $(344,213)$(587,022)$77,595 $37,035 $1.42 

[1] Reflects certain items captured in the GAAP carve-out financial statements that have not continued post-spin, including, but not limited to, facilities that did not convey with ZimVie in the spin, redundant personnel costs incurred as a result of the spin, and the difference between the pre-spin allocations of Zimmer Biomet’s corporate costs in accordance with GAAP, versus the expected post-spin corporate costs for ZimVie.
[2] In June 2022 and November 2022, we instituted restructuring plans and the expenses incurred in the three and twelve months ended December 31, 2022 under these plans were primarily related to employee termination benefits and the exit of our spine products operations in China as a result of an unsuccessful volume-based procurement program bid. Zimmer Biomet instituted restructuring plans in the fourth quarters of 2019 and 2021, and the restructuring costs we incurred under those plans were primarily related to employee termination benefits, contract terminations and retention period compensation and benefits.
[3] Acquisition, integration, divestiture, and related costs are limited to a specific period of time and related to ZimVie being established as a standalone public company.
[4] Expenses incurred for initial compliance with the European Union ("EU") Medical Device Regulation ("MDR") for previously- approved products.
[5] One-time expenses captured through allocations made for purposes of the GAAP carve-out financial statement results. The adjustments to cost of products sold in Q4 2021 were one-time charges due to the spine brand rationalization project. The adjustments to cost of products sold in Q4 2022 were related to non-cash asset write offs from the exit of our Spine products operations in China as a result of an unsuccessful VBP bid.
[6] One-time share-based compensation expense due to replacement awards provided in connection with the separation from Zimmer Biomet.
[7] Tax benefit in Q3 2022 from a favorable Puerto Rico tax ruling related to the intercompany sale of intellectual property prior to the spin.

Reconciliation of Adjusted EBITDA (in thousands)

  For the Three Months
Ended December 31,
 For the Twelve Months
Ended December 31,
   2022  2021   2022  2021 
Net Sales      
Third party, net $228,164 $260,596  $909,487 $1,008,830 
Related party, net  956  977   4,375  5,819 
Total Net Sales $229,120 $261,573  $913,862 $1,014,649 
       
Net Income (Loss)  (30,344) (60,691)  (63,881) (95,254)
Interest expense, net  6,432  (16)  18,279  292 
Income tax benefit  2,127  (4,702)  (46,038) (6,003)
Depreciation and amortization  30,320  33,992   122,374  129,659 
EBITDA  8,535  (31,417)  30,734  28,694 
Share-based compensation  5,307  2,273   31,224  11,079 
Restructuring[1]  4,868  1,053   11,354  3,344 
Acquisition, integration, divestiture and related[2]  3,982  12,053   29,437  24,064 
Related party income  (26) (125)  (268) (1,254)
European medical device regulation[3]  3,510  3,092   10,064  5,627 
Pre vs. post-spin cost structure differences[4]    3,027   5,271  7,439 
One-time carve-out allocations and other one-time costs[5]  1,875  40,159   4,726  52,656 
Adjusted EBITDA $28,051 $30,115  $122,542 $131,649 
Net Income (Loss) Margin[6]  -13.3% -23.3%  -7.0% -9.4%
Adjusted EBITDA Margin[7]  12.3% 11.6%  13.5% 13.0%

[1] In June 2022 and November 2022, we instituted restructuring plans and the expenses incurred in the three and twelve months ended December 31, 2022 under these plans were primarily related to employee termination benefits and the exit of our spine products operations in China as a result of an unsuccessful volume-based procurement program bid. Zimmer Biomet instituted restructuring plans in the fourth quarters of 2019 and 2021, and the restructuring costs we incurred under those plans were primarily related to employee termination benefits, contract terminations and retention period compensation and benefits.
[2] Acquisition, integration, divestiture, and related costs are limited to a specific period of time and related to ZimVie being established as a standalone public company.
[3] Expenses incurred for initial compliance with the EU MDR for previously-approved products.
[4] Reflects certain items captured in the GAAP carve-out financial statements that have not continued post-spin, including, but not limited to, facilities that did not convey with ZimVie in the spin, redundant personnel costs incurred as a result of the spin, and the difference between the pre-spin allocations of Zimmer Biomet’s corporate costs in accordance with GAAP, versus the expected post-spin corporate costs for ZimVie.
[5] One-time expenses captured through allocations made for purposes of the GAAP carve-out financial statement results. The adjustments to cost of products sold in Q4 2021 were one-time charges due to the spine brand rationalization project. The adjustments to cost of products sold in Q4 2022 were related to non-cash asset write offs from the exit of our Spine products operations in China as a result of an unsuccessful VBP bid..
[6] Net Income (Loss) Margin is calculated as Net Income (Loss) divided by third-party net sales for the applicable period
[7] Adjusted EBITDA Margin is Adjusted EBITDA divided by third party net sales for the applicable period.

Reconciliation of Adjusted Effective Tax Rate

 Three Months Ended
December 31,
 Twelve Months Ended
December 31,
 2022  2021  2022  2021 
Effective tax rate(7.5)% 7.2% 41.9% 6.0%
Tax effect of adjustments made to earnings before taxes(1)53.7  154.4  (45.0) 45.8 
Other certain tax adjustments-  -  (0.7) - 
Adjusted effective tax rate46.2% 161.6% (3.8)% 51.8%

[1] Includes intangible asset amortization; restructuring and other cost reduction initiatives; acquisition, integration, divestiture and related; litigation; EU MDR; and other charges.

Astria Therapeutics

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