Health Canada Approves KEYTRUDA® for the treatment of adult patients with FIGO 2014 Stage III-IVA cervical cancer, in combination with chemoradiotherapy (CRT)¹ Français
"The approval of KN-A18 is an important addition to the treatment of gynecological cancers, as it has demonstrated a statistically significant improvement in overall survival and progression-free survival in patients with FIGO 2014 Stage III-IVa," stated Shannon Salvador, Gynecologic Oncologist at the Jewish General Hospital and President of the Society of Gynecologic Oncology of Canada. 4"This recent approval adds another therapeutic option for patients in an important disease space."
"This approval marks a pivotal moment for patients, as it represents the first indication in Canada for KEYTRUDA ® in combination with chemoradiotherapy," said André Galarneau, PhD, Executive Director & Vice President, Oncology Business Unit at Merck Canada. "Reaffirming our commitment to cervical cancer, we are eager to continue expanding treatment options for patients impacted by this disease." 5
About KEYNOTE-A18 / ENGOT-cx11/GOG-3047
KEYNOTE-A18 is a multicenter, randomized, double-blind, placebo-controlled phase III trial (ClinicalTrials.gov, NCT04221945). 2 The trial investigated the efficacy of pembrolizumab in combination with CRT (cisplatin and external beam radiation therapy [EBRT] followed by brachytherapy [BT]) for the treatment of patients with locally advanced cervical cancer. 1
The trial enrolled 1,060 newly diagnosed patients with locally advanced squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix defined as FIGO 2014 stage IB2 to IIB with positive lymph nodes or stage III to IVA regardless of nodal status. 3 There were 599 patients with FIGO 2014 Stage III-IVA.
Randomization was stratified by planned type of EBRT (Intensity modulated radiation therapy [IMRT] or volumetric modulated arc therapy [VMAT] vs. non IMRT and non VMAT), stage at screening of cervical cancer (FIGO 2014 Stage IB2 IIB vs. FIGO 2014 Stage III-IVA), and planned total radiotherapy dose (EBRT + brachytherapy dose of <70 Gy vs. ≥70 Gy as per equivalent dose [EQD2]). 1
Patients were randomized (1:1) to one of two treatment arms:
Pembrolizumab 200 mg IV every 3 weeks (5 cycles) concurrent with cisplatin 40 mg/m2 IV weekly (5 cycles, an optional sixth infusion could be administered per local practice) and radiotherapy (EBRT followed by BT), followed by pembrolizumab 400 mg IV every 6 weeks (15 cycles). 1,3
Placebo IV every 3 weeks (5 cycles) concurrent with cisplatin 40 mg/m2 IV weekly (5 cycles, an optional sixth infusion could be administered per local practice), and radiotherapy (EBRT followed by BT), followed by placebo IV every 6 weeks (15 cycles). 1,3
Treatment continued until RECIST (Response Evaluation Criteria in Solid Tumors) v1.1-defined progression of disease as determined by investigator or unacceptable toxicity. 1
Assessment of tumour status was performed every 12 weeks from completion of CRT for the first two years, followed by every 24 weeks in year 3, and then annually. The major efficacy outcome measures were PFS as assessed by investigator according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, or histopathologic confirmation, and OS. 1
The trial demonstrated statistically significant improvements in both PFS (HR (Hazard Ratio) 0.70; 95% CI (confidence interval): 0.55–0.89; p = 0.002) and OS (HR 0.67; 95% CI: 0.50–0.90; p = 0.004) in the overall population. In an exploratory subgroup analysis for the 459 patients (43%) with FIGO 2014 Stage IB2–IIB disease, the PFS and OS HR estimates were 0.91 (95% CI: 0.63–1.32) and 0.89 (95% CI: 0.55–1.44), respectively, suggesting that the improvements in PFS and OS observed in the overall population were primarily driven by the later-stage subgroup of patients with FIGO 2014 Stage III–IVA disease.
The efficacy results in the exploratory subgroup analysis of 599 patients with FIGO 2014 Stage III-IVA disease showed that pembrolizumab plus CRT demonstrated improvements in PFS (Hazard Ratio (HR) 0.59; 95% CI 0.43, 0.81) and OS (HR 0.58; 95% CI 0.40, 0.85) in the overall population. 1
For the FIGO 2014 Stage III-IVA population, the most common treatment-related adverse events (reported in at least 20% of patients) were anemia, nausea, diarrhea, white blood cell count decreased, neutrophil count decreased, vomiting, platelet count decreased, and hypothyroidism. 6
For complete information, refer to the KEYTRUDA ® product monograph.
About cervical cancer
Cervical cancer forms in the cells lining the cervix, which is the lower part of the uterus. 7 Despite concerted efforts in screening and prevention across Canada, cervical cancer has become the fastest growing cancer type in females. 8,9 In 2024 alone, it was estimated that there were approximately 1,600 women diagnosed with cervical cancer and an estimated 400 deaths as a result of the disease. 10
About KEYTRUDA ®
KEYTRUDA ® is an anti-programmed death receptor-1 (anti-PD-1) therapy that works by helping increase the ability of the body's immune system to help detect and fight tumour cells. KEYTRUDA ® is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumour cells and healthy cells. 11,12,13
KEYTRUDA ® was first approved in Canada in 2015 and currently has indications in several disease areas, including advanced renal cell carcinoma, bladder cancer, non-small cell lung carcinoma, primary mediastinal B-cell lymphoma, classical Hodgkin lymphoma, colorectal cancer, endometrial carcinoma, cervical cancer, esophageal cancer, triple-negative breast cancer, melanoma, and head and neck squamous cell carcinoma. 14
About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable, and healthy future for all people and communities. For more information about our operations in Canada, visit www.merck.ca and connect with us on LinkedIn @MerckCanada.
Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2023 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).
® Merck Sharp & Dohme LLC. Used under license.
© 2025 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.
CA-NON-04142
1 KEYTRUDA ® Product Monograph, page 285-286.
2 https://clinicaltrials.gov/study/NCT04221945
3 The ASCO Post. KEYNOTE-A18: Overall Survival in Cervical Cancer Improved by Pembrolizumab Plus Chemoradiotherapy. https://ascopost.com/issues/october-10-2024/keynote-a18-overall-survival-in-cervical-cancer-improved-by-pembrolizumab-plus-chemoradiotherapy/
4 Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 trial, page 1329.
5 https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1426
6 KEYTRUDA ® Product Monograph, page 146.
7 Canadian Cancer Society. What is cervical cancer?
8 Canadian Cancer Statistics 2023, page 22. https://cdn.cancer.ca/-/media/files/research/cancer-statistics/2023-statistics/2023_pdf_en.pdf?rev=7e0c86ef787d425081008ed22377754d&hash=DBD6818195657364D831AF0641C4B45C
9 Canadian Cancer Statistics 2023, page 80. https://cdn.cancer.ca/-/media/files/research/cancer-statistics/2023-statistics/2023_pdf_en.pdf?rev=7e0c86ef787d425081008ed22377754d&hash=DBD6818195657364D831AF0641C4B45C
10 Canadian Cancer Society. Cervical cancer statistics. https://cancer.ca/en/cancer-information/cancer-types/cervical/statistics
11 KEYTRUDA ® Product Monograph, page 300.
12 KEYTRUDA ® Product Monograph, page 188.
13 KEYTRUDA ® Product Monograph, page 192.
14 KEYTRUDA ® Product Monograph, pages 1-3.
Media Contacts:
Merck Canada Media Relations
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[email protected]
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Fiscal Quarter Ended Two Fiscal Quarters Ended June 28, 2025 June 29, 2024 June 28, 2025 June 29, 2024 Net sales $ 585,313 $ 564,434 $ 1,215,139 $ 1,225,926 Cost of goods sold 303,553 281,497 642,289 627,799 Gross profit 281,760 282,937 572,850 598,127 Royalty income, net 3,249 4,004 8,580 9,220 Selling, general, and administrative expenses 280,965 247,489 551,284 512,859 Operating income 4,044 39,452 30,146 94,488 Interest expense 7,857 7,870 15,676 15,775 Interest income (4,292 ) (3,186 ) (7,434 ) (6,274 ) Other (income) expense, net (1,224 ) 404 (1,148 ) 678 Income before income taxes 1,703 34,364 23,052 84,309 Income tax provision 1,257 6,725 7,067 18,637 Net income $ 446 $ 27,639 $ 15,985 $ 65,672 Basic net income per common share $ 0.01 $ 0.76 $ 0.43 $ 1.80 Diluted net income per common share $ 0.01 $ 0.76 $ 0.43 $ 1.80 Dividend declared and paid per common share $ 0.25 $ 0.80 $ 1.05 $ 1.60 CARTER'S, INC. 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Segment operating income includes net sales, royalty income, and related cost of goods sold and selling, general, and administrative expenses attributable to each segment. Segment operating income excludes unallocated corporate expenses as well as specific charges that are not directly attributable to segment operations, including restructuring costs, operating model improvement costs, leadership transition costs, and impairment charges related to goodwill and indefinite-lived intangible assets, which were included in our previous measure of segment profitability. Prior period segment operating income for the fiscal quarter and two fiscal quarters ended June 29, 2024 have been recast to conform to the current presentation. (2) Unallocated corporate expenses include corporate overhead expenses that are not directly attributable to one of our business segments and include unallocated accounting, finance, legal, human resources, and information technology expenses, occupancy costs for our corporate headquarters, and other benefit and compensation programs, including performance-based compensation. (3) Primarily related to third-party consulting costs. Note: Results may not be additive due to rounding. CARTER'S, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (dollars in thousands, except per share data) (unaudited) June 28, 2025 December 28, 2024 June 29, 2024 ASSETS Current assets: Cash and cash equivalents $ 338,183 $ 412,926 $ 316,646 Accounts receivable, net of allowance for credit losses of $6,340, $5,663, and $4,895, respectively 140,352 194,834 132,360 Finished goods inventories, net of inventory reserves of $10,284, $8,257, and $13,844, respectively 619,074 502,332 599,295 Prepaid expenses and other current assets 60,612 32,580 54,085 Total current assets 1,158,221 1,142,672 1,102,386 Property, plant, and equipment, net of accumulated depreciation of $598,575, $602,670, and $640,751, respectively 188,177 180,956 181,659 Operating lease assets 571,303 577,133 509,168 Tradenames, net 268,777 268,008 298,097 Goodwill 209,016 206,875 209,086 Customer relationships, net 21,854 23,543 25,386 Other assets 38,204 33,980 29,735 Total assets $ 2,455,552 $ 2,433,167 $ 2,355,517 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable $ 306,399 $ 248,200 $ 313,796 Current operating lease liabilities 124,002 130,564 128,952 Other current liabilities 95,270 130,052 84,895 Total current liabilities 525,671 508,816 527,643 Long-term debt, net 498,531 498,127 497,735 Deferred income taxes 42,290 38,210 48,910 Long-term operating lease liabilities 501,804 501,503 436,575 Other long-term liabilities 33,354 31,949 32,904 Total liabilities $ 1,601,650 $ 1,578,605 $ 1,543,767 Commitments and contingencies Shareholders' equity: Preferred stock; par value $0.01 per share; 100,000 shares authorized; none issued or outstanding $ — $ — $ — Common stock, voting; par value $0.01 per share; 150,000,000 shares authorized; 36,467,071, 36,041,995, and 36,280,056 shares issued and outstanding, respectively 365 360 363 Additional paid-in capital 14,460 3,856 — Accumulated other comprehensive loss (32,817 ) (43,678 ) (32,814 ) Retained earnings 871,894 894,024 844,201 Total shareholders' equity 853,902 854,562 811,750 Total liabilities and shareholders' equity $ 2,455,552 $ 2,433,167 $ 2,355,517 CARTER'S, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (dollars in thousands) (unaudited) Two Fiscal Quarters Ended June 28, 2025 June 29, 2024 Cash flows from operating activities: Net income $ 15,985 $ 65,672 Adjustments to reconcile net income to net cash (used in) provided by operating activities: Depreciation of property, plant, and equipment 24,967 27,386 Amortization of intangible assets 1,846 1,858 Provision for excess and obsolete inventory, net 1,853 4,986 (Gain) loss on disposal of property, plant and equipment (4 ) 87 Amortization of debt issuance costs 832 809 Stock-based compensation expense 14,941 9,290 Unrealized foreign currency exchange (gain) loss, net (799 ) 109 Provision for doubtful accounts receivable from customers 1,182 285 Unrealized gain on investments (474 ) (1,081 ) Deferred income taxes expense 3,549 7,153 Effect of changes in operating assets and liabilities: Accounts receivable 54,068 50,516 Finished goods inventories (114,014 ) (70,802 ) Prepaid expenses and other assets (30,218 ) (24,320 ) Accounts payable and other liabilities 17,948 19,743 Net cash (used in) provided by operating activities $ (8,338 ) $ 91,691 Cash flows from investing activities: Capital expenditures $ (26,546 ) $ (24,315 ) Net cash used in investing activities $ (26,546 ) $ (24,315 ) Cash flows from financing activities: Dividends paid $ (38,115 ) $ (58,510 ) Repurchases of common stock — (33,778 ) Withholdings from vesting of restricted stock (4,332 ) (7,436 ) Proceeds from exercises of stock options — 367 Other (370 ) — Net cash used in financing activities $ (42,817 ) $ (99,357 ) Net effect of exchange rate changes on cash and cash equivalents 2,958 (2,586 ) Net decrease in cash and cash equivalents $ (74,743 ) $ (34,567 ) Cash and cash equivalents, beginning of period 412,926 351,213 Cash and cash equivalents, end of period $ 338,183 $ 316,646 CARTER'S, INC. (dollars in millions, except earnings per share) (unaudited) Fiscal Quarter Ended June 28, 2025 SG&A % Net Sales Operating Income % Net Sales Income Taxes Net Income Diluted EPS As reported (GAAP) $ 281.0 48.0 % $ 4.0 0.7 % $ 1.3 $ 0.4 $ 0.01 Operating model improvement costs (b) (6.6 ) 6.6 1.6 5.0 0.14 Leadership transition costs (c) (1.1 ) 1.1 0.3 0.8 0.02 As adjusted (a) $ 273.3 46.7 % $ 11.8 2.0 % $ 3.1 $ 6.3 $ 0.17 Two Fiscal Quarters Ended June 28, 2025 SG&A % Net Sales Operating Income % Net Sales Income Taxes Net Income Diluted EPS As reported (GAAP) $ 551.3 45.4 % $ 30.1 2.5 % $ 7.1 $ 16.0 $ 0.43 Operating model improvement costs (b) (9.8 ) 9.8 2.4 7.4 0.21 Leadership transition costs (c) (7.2 ) 7.2 0.6 6.6 0.18 As adjusted (a) $ 534.3 44.0 % $ 47.1 3.9 % $ 10.0 $ 30.1 $ 0.83 (a) In addition to the results provided in this earnings release in accordance with GAAP, the Company has provided adjusted, non-GAAP financial measurements that present SG&A, operating income, income tax, net income, and net income on a diluted share basis excluding the adjustments discussed above. The Company believes these adjustments provide a meaningful comparison of the Company's results and afford investors a view of what management considers to be the Company's core performance. The adjusted, non-GAAP financial measurements included in this earnings release should not be considered as an alternative to net income or as any other measurement of performance derived in accordance with GAAP. The adjusted, non-GAAP financial measurements are presented for informational purposes only and are not necessarily indicative of the Company's future condition or results of operations. (b) Primarily related to third-party consulting costs. Weighted-average number of common and common equivalent shares outstanding: Basic number of common shares outstanding 35,409,988 35,688,755 35,361,039 35,774,748 Dilutive effect of equity awards — 135 605 1,692 Diluted number of common and common equivalent shares outstanding 35,409,988 35,688,890 35,361,644 35,776,440 As reported on a GAAP Basis: (dollars in thousands, except per share data) Basic net income per common share: Net income $ 446 $ 27,639 $ 15,985 $ 65,672 Income allocated to participating securities (231 ) (523 ) (866 ) (1,218 ) Net income available to common shareholders $ 215 $ 27,116 $ 15,119 $ 64,454 Basic net income per common share $ 0.01 $ 0.76 $ 0.43 $ 1.80 Diluted net income per common share: Net income $ 446 $ 27,639 $ 15,985 $ 65,672 Income allocated to participating securities (231 ) (523 ) (866 ) (1,218 ) Net income available to common shareholders $ 215 $ 27,116 $ 15,119 $ 64,454 Diluted net income per common share $ 0.01 $ 0.76 $ 0.43 $ 1.80 As adjusted (a): Basic net income per common share: Net income $ 6,302 $ 27,639 $ 30,052 $ 65,672 Income allocated to participating securities (231 ) (523 ) (866 ) (1,218 ) Net income available to common shareholders $ 6,071 $ 27,116 $ 29,186 $ 64,454 Basic net income per common share $ 0.17 $ 0.76 $ 0.83 $ 1.80 Diluted net income per common share: Net income $ 6,302 $ 27,639 $ 30,052 $ 65,672 Income allocated to participating securities (231 ) (523 ) (866 ) (1,218 ) Net income available to common shareholders $ 6,071 $ 27,116 $ 29,186 $ 64,454 Diluted net income per common share $ 0.17 $ 0.76 $ 0.83 $ 1.80 (a) In addition to the results provided in this earnings release in accordance with GAAP, the Company has provided adjusted, non-GAAP financial measurements that present per share data excluding the adjustments discussed above. The Company has excluded $5.9 million and $14.1 million in after-tax expenses from these results for the fiscal quarter and two fiscal quarters ended June 28, 2025, respectively. Note: Results may not be additive due to rounding. RECONCILIATION OF U.S. GAAP AND NON-GAAP INFORMATION (dollars in millions) (unaudited) The following table provides a reconciliation of net income to EBITDA and Adjusted EBITDA for the periods indicated: Fiscal Quarter Ended Two Fiscal Quarters Ended Four Fiscal Quarters Ended June 28, 2025 June 29, 2024 June 28, 2025 June 29, 2024 June 28, 2025 Net income $ 0.4 $ 27.6 $ 16.0 $ 65.7 $ 135.8 Interest expense 7.9 7.9 15.7 15.8 31.2 Interest income (4.3 ) (3.2 ) (7.4 ) (6.3 ) (12.2 ) Income tax expense 1.3 6.7 7.1 18.6 33.7 Depreciation and amortization 13.6 14.4 26.8 29.2 55.5 EBITDA $ 18.8 $ 53.5 $ 58.1 $ 123.1 $ 244.1 Adjustments to EBITDA Operating model improvement costs (a) $ 6.6 $ — $ 9.8 $ — $ 9.8 Leadership transition costs (b) 1.1 — 7.2 — 7.2 Organizational restructuring (c) — — — — 1.8 Intangible asset impairment (d) — — — — 30.0 Partial pension plan settlement (e) — — — — 0.9 Total adjustments 7.7 — 17.0 — 49.8 Adjusted EBITDA $ 26.5 $ 53.5 $ 75.0 $ 123.1 $ 293.8 (a) Primarily related to third-party consulting costs. (b) Related to costs associated with the transition of our former CEO, including accelerated vesting of outstanding time-based restricted stock awards. (c) Net expenses related to organizational restructuring. (d) Non-cash impairment charge on the OshKosh indefinite-lived tradename asset. (e) Non-cash charge for partial settlement of the OshKosh B'Gosh Pension Plan. Note: Results may not be additive due to rounding. EBITDA and Adjusted EBITDA are supplemental financial measures that are not defined or prepared in accordance with GAAP. We define EBITDA as net income before interest, income taxes, and depreciation and amortization. Adjusted EBITDA is EBITDA adjusted for the items described in footnotes (a) - (e) to the table above. We present EBITDA and Adjusted EBITDA because we consider them important supplemental measures of our performance and believe they are frequently used by securities analysts, investors, and other interested parties in the evaluation of companies in our industry. These measures also afford investors a view of what management considers to be the Company's core performance. The use of EBITDA and Adjusted EBITDA instead of net income or cash flows from operations has limitations as an analytical tool, and you should not consider them in isolation, or as a substitute for analysis of our results as reported under GAAP. EBITDA and Adjusted EBITDA do not represent net income or cash flow from operations as those terms are defined by GAAP and do not necessarily indicate whether cash flows will be sufficient to fund cash needs. While EBITDA, Adjusted EBITDA and similar measures are frequently used as measures of operations and the ability to meet debt service requirements, these terms are not necessarily comparable to other similarly titled captions of other companies due to the potential inconsistencies in the method of calculation. EBITDA and Adjusted EBITDA do not reflect the impact of earnings or charges resulting from matters that we consider not to be indicative of our ongoing operations. Because of these limitations, EBITDA and Adjusted EBITDA should not be considered as discretionary cash available to us for working capital, debt service and other purposes. Two Fiscal Quarters Ended Reported Net Sales June 28, 2025 Impact of Foreign Currency Translation Constant- Currency Net Sales June 28, 2025 Reported Net Sales June 29, 2024 Reported Net Sales % Change Constant- Currency Net Sales % Change Consolidated net sales $ 1,215.1 $ (9.5 ) $ 1,224.6 $ 1,225.9 (0.9 )% (0.1 )% International segment net sales $ 178.1 $ (9.5 ) $ 187.6 $ 171.0 4.1 % 9.7 % Note: Results may not be additive due to rounding. The Company evaluates its net sales on both an 'as reported' and a 'constant currency' basis. The constant currency presentation, which is a non-GAAP measure, excludes the impact of fluctuations in foreign currency exchange rates that occurred between the comparative periods. Constant currency net sales results are calculated by translating current period net sales in local currency to the U.S. dollar amount by using the currency conversion rate for the prior comparative period. The Company consistently applies this approach to net sales for all countries where the functional currency is not the U.S. dollar. The Company believes that the presentation of net sales on a constant currency basis provides useful supplemental information regarding changes in our net sales that were not due to fluctuations in currency exchange rates and such information is consistent with how the Company assesses changes in its net sales between comparative periods.
