Delcath Systems to Present at Upcoming Investor Conferences in August

On July 27, 2022 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that it will present at the following investor conferences in August (Press release, Delcath Systems, JUL 27, 2022, View Source [SID1234617645]):

Schedule your 30 min Free 1stOncology Demo!
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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

BTIG Biotechnology Conference 2022 on August 9, 2022.
Canaccord Genuity 42nd Annual Growth Conference: Presentation to take place on August 10, 2022 at 12:30PM ET. A webcast of the presentation will be available at: View Source
To learn more or to schedule a one-on-one meeting with management, please contact your conference representative or [email protected].

Boston Scientific Announces Results for Second Quarter 2022

On July 27, 2022 Boston Scientific Corporation reported net sales of $3.244 billion during the second quarter of 2022, growing 5.4 percent on a reported basis, 9.6 percent on an operational1 basis and 6.6 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, JUL 27, 2022, View Source [SID1234618927]). The company reported GAAP net income available to common stockholders of $246 million or $0.17 per share (EPS), compared to $172 million or $0.12 per share a year ago, and achieved adjusted3 EPS of $0.44 for the period, compared to $0.40 a year ago.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

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"We had another quarter of excellent performance, a testament to the talent of our global team, the sustainability and diversification of our innovative medical technology portfolio and our strong market positions amid continued macroeconomic challenges," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "As we continue to execute our strategy, we have a tremendous opportunity to continue to deliver on our promise to bring life-changing devices and therapies to more patients who need them."

Second quarter financial results and recent developments:

Reported net sales of $3.244 billion, representing an increase of 5.4 percent on a reported basis, compared to the company’s guidance range of 3 to 6 percent; 9.6 percent on an operational basis; and 6.6 percent on an organic basis, compared to the company’s guidance range of 3 to 6 percent, all compared to the prior year period.
Reported GAAP net income available to common stockholders of $0.17 per share, compared to the company’s guidance range of $0.19 to $0.23 per share, and achieved adjusted EPS of $0.44 per share, compared to the guidance range of $0.41 to $0.43 per share.
Achieved net sales growth in each reportable segment4, compared to the prior year period:
MedSurg: 4.5 percent reported, 7.9 percent operational and 4.8 percent organic
Cardiovascular: 6.0 percent reported, 10.8 percent operational and 7.8 percent organic
Achieved the following regional net sales growth/(decline), compared to the prior year period:
U.S.: 7.4 percent reported and operational
EMEA (Europe, Middle East and Africa): (0.3) percent reported and 11.8 percent operational
APAC (Asia-Pacific): 1.9 percent reported and 11.2 percent operational
Emerging Markets5: 18.9 percent reported and 26.0 percent operational
Received U.S. Food and Drug Administration (FDA) 510(k) clearance for and launched the VersaCross Connect LAAC Access Solution developed by Baylis Medical, featuring a shapable dilator and the radiofrequency (RF) energy technology of the VersaCross RF Transseptal Solution, compatible with the WATCHMAN FXD Curve Access Sheath to provide safe and efficient access to the left side of the heart for WATCHMAN FLX implants.
Received National Medical Products Administration approval in China for the Tria Firm Ureteral Stent. The Tria stent incorporates proprietary PercuShield technology engineered to provide protection against the accumulation of both urine calcium and magnesium salt deposits during indwell.
Late-breaking data from 54,000 patients in the NCDR-LAAO Registry presented at Heart Rhythm 2022 demonstrated that the WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device was associated with a significantly lower (43% reduction) rate of in-hospital major adverse events compared with the previous-generation device driven by lower rates of pericardial effusion requiring intervention and major bleeding.
Late-breaking registry data—including a European study presented at TVT and the latest data from the Italian ITAL-neo Registry presented at EuroPCR—supported reduced paravalvular leak (PVL) and superior performance of the ACURATE neo2 Aortic Valve System over the previous-generation valve.
The investigator-sponsored ATLAS trial demonstrated a highly significant 92 percent reduction in serious lead-related complications at six months for the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) compared to single chamber transvenous ICD devices. ATLAS is the first prospective randomized controlled trial whose primary objective was to evaluate lead-related complication rates between the S-ICD and single chamber TV-ICD devices at six months after implant.
Completed enrollment in the ADVENT clinical trial—a prospective, multi-center, randomized safety and effectiveness pivotal study comparing the FARAPULSE Pulsed Field Ablation (PFA) System to standard-of-care ablation in patients with paroxysmal—or intermittent —atrial fibrillation (AF) with a primary endpoint of freedom from AF at 12 months after a single ablation procedure.
Completed enrollment in the NEwTON AF clinical trial – a prospective, multi-center, single-arm study to establish the safety and effectiveness of the INTELLANAV STABLEPOINT Ablation Catheter and Force-Sensing System in patients with symptomatic, drug-refractory, recurrent paroxysmal atrial fibrillation.
Announced agreement to purchase the majority stake of M.I.Tech Co., Ltd from Synergy Innovation Co., Ltd, subject to customary closing conditions, to broaden and complement the Boston Scientific portfolio of gastrointestinal and airway stents.
Released 2021 Performance Report, highlighting the company’s achievements in advancing environmental, social and governance (ESG) priorities to transform care, invest in employees, accelerate possibilities, protect the environment and create value responsibly.

1. Operational net sales growth excludes the impact of foreign currency fluctuations.

2. Organic net sales growth excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales.

3. Adjusted EPS excludes the impacts of certain charges (credits) which may include amortization expense, goodwill and intangible asset impairment charges, acquisition/divestiture-related net charges (credits), investment portfolio gains and losses, restructuring and restructuring-related net charges (credits), certain litigation-related net charges (credits), EU MDR implementation costs, debt extinguishment charges, deferred tax expenses (benefits) and discrete tax items.

4. In the first quarter of 2022, we reorganized our operational structure and have aggregated our core businesses, each of which generate revenues from the sale of medical devices (Medical Devices), into two reportable segments comprised of MedSurg and Cardiovascular. Within the Cardiovascular segment, the newly formed Cardiology division represents the combined former Rhythm Management and Interventional Cardiology businesses. We have revised prior period amounts to conform to the current year presentation.

5. We define Emerging Markets as the 20 countries that we believe have strong growth potential based on their economic conditions, healthcare sectors and our global capabilities.

Net sales for the second quarter by business and region:

Increase/(Decrease)

Three Months Ended

June 30,

Reported Basis

Less: Impact
of Foreign
Currency
Fluctuations

Operational

Basis

Less:

Impact of
Recent
Acquisitions
/ Divestitures

Organic
Basis

(in millions)

2022

2021

Endoscopy

$ 560

$ 551

1.6 %

(4.3) %

5.8 %

— %

5.8 %

Urology and Pelvic Health

450

397

13.4 %

(2.8) %

16.2 %

9.2 %

7.0 %

Neuromodulation

239

247

(3.4) %

(2.4) %

(1.0) %

— %

(1.0) %

MedSurg4

1,248

1,195

4.5 %

(3.4) %

7.9 %

3.1 %

4.8 %

Cardiology

1,517

1,410

7.6 %

(4.8) %

12.5 %

4.0 %

8.5 %

Peripheral Interventions

478

473

1.2 %

(4.5) %

5.7 %

— %

5.7 %

Cardiovascular4

1,996

1,883

6.0 %

(4.7) %

10.8 %

3.0 %

7.8 %

Medical Devices4

3,244

3,077

5.4 %

(4.2) %

9.6 %

3.0 %

6.6 %

Net Sales

$ 3,244

$ 3,077

5.4 %

(4.2) %

9.6 %

3.0 %

6.6 %

Increase/(Decrease)

Three Months
Ended June 30,

Reported
Basis

Less: Impact
of Foreign
Currency
Fluctuations

Operational

Basis

(in millions)

2022

2021

U.S.

$ 1,933

$ 1,800

7.4 %

— %

7.4 %

EMEA

660

662

(0.3) %

(12.2) %

11.8 %

APAC

530

520

1.9 %

(9.3) %

11.2 %

Latin America and Canada

120

95

26.8 %

(1.1) %

27.9 %

Medical Devices4

3,244

3,077

5.4 %

(4.2) %

9.6 %

Net Sales

$ 3,244

$ 3,077

5.4 %

(4.2) %

9.6 %

Emerging Markets5

$ 427

$ 359

18.9 %

(7.1) %

26.0 %

Amounts may not add due to rounding. Growth rates are based on actual, non-rounded amounts and may not recalculate precisely.

Growth rates that exclude the impact of foreign currency fluctuations and/or the impact of acquisitions / divestitures are not prepared in accordance with U.S. GAAP.

Guidance for Full Year and Third Quarter 2022

The company now estimates net sales growth for the full year 2022, versus the prior year period, to be in a range of approximately 6.5 to 7.5 percent on a reported basis, and approximately 8 to 9 percent on an organic basis. Full year organic net sales guidance excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales. The company now estimates EPS on a GAAP basis in a range of $0.69 to $0.76 and estimates adjusted EPS, excluding certain charges (credits), of $1.74 to $1.77.

The company estimates net sales growth for the third quarter of 2022, versus the prior year period, to be in a range of approximately 6 to 8 percent on a reported basis, and approximately 8 to 10 percent on an organic basis. Third quarter organic net sales guidance excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales. The company estimates EPS on a GAAP basis in a range of $0.20 to $0.24 and adjusted EPS, excluding certain charges (credits), of $0.43 to $0.45.

Conference Call Information

Boston Scientific management will be discussing these results with analysts on a conference call today at 8:00 a.m. ET. The company will webcast the call to interested parties through its website: www.bostonscientific.com. Please see the website for details on how to access the webcast. The webcast will be available for approximately one year on the Boston Scientific website.

About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "may," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our expected net sales; reported, operational and organic revenue growth rates; reported and adjusted EPS for the third quarter and full year 2022; our financial performance; our business plans and product performance; and the impact of the COVID-19 pandemic on the company’s results of operations. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Risks and uncertainties that may cause such differences include, among other things: the impact of the ongoing COVID-19 pandemic on our operations and financial results; the impact of foreign currency fluctuations; future U.S. and global economic, political, competitive, reimbursement and regulatory conditions; manufacturing, distribution and supply chain disruptions and cost increases; disruptions caused by cybersecurity events; disruptions caused by extreme weather or other climate change-related events; labor shortages and increases in labor costs; new product introductions; expected procedural volumes; the closing and integration of acquisitions; demographic trends; intellectual property rights; litigation; financial market conditions; the execution and effect of our business strategy, including our cost-savings and growth initiatives; and future business decisions made by us and our competitors. New risks and uncertainties may arise from time to time and are difficult to predict, including those that have emerged or have increased in significance or likelihood as a result of the COVID-19 pandemic. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this press release.

Note: Amounts reported in millions within this press release are computed based on the amounts in thousands. As a result, the sum of the components reported in millions may not equal the total amount reported in millions due to rounding. Certain columns and rows within tables may not add due to the use of rounded numbers. Percentages presented are calculated from the underlying numbers in dollars.

Use of Non-GAAP Financial Information
A reconciliation of the company’s non-GAAP financial measures to the corresponding GAAP measures, and an explanation of the company’s use of these non-GAAP financial measures, is included in the exhibits attached to this press release.

CONTACT:

Media:

Kate Haranis

Investors:

Lauren Tengler

508-683-6585 (office)

508-683-4479 (office)

Media Relations

Investor Relations

Boston Scientific Corporation

Boston Scientific Corporation

[email protected]

[email protected]

BOSTON SCIENTIFIC CORPORATION

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

Three Months Ended

June 30,

Six Months Ended

June 30,

in millions, except per share data

2022

2021

2022

2021

Net sales

$ 3,244

$ 3,077

$ 6,270

$ 5,829

Cost of products sold

1,011

945

1,966

1,839

Gross profit

2,233

2,132

4,304

3,990

Operating expenses:

Selling, general and administrative expenses

1,165

1,121

2,225

2,139

Research and development expenses

335

298

654

574

Royalty expense

11

12

23

24

Amortization expense

204

180

402

365

Intangible asset impairment charges

7

45

7

45

Contingent consideration net expense (benefit)

36

(85)

48

(91)

Restructuring net charges (credits)

11

3

14

8

Litigation-related net charges (credits)

42

298

42

302

Gain on disposal of businesses and assets

(2)

(9)

1,810

1,870

3,415

3,358

Operating income (loss)

423

262

889

632

Other income (expense):

Interest expense

(64)

(86)

(343)

(168)

Other, net

(14)

(26)

(46)

11

Income (loss) before income taxes

345

149

501

474

Income tax expense (benefit)

85

(37)

131

(53)

Net income (loss)

$ 260

$ 186

$ 370

$ 527

Preferred stock dividends

(14)

(14)

(28)

(28)

Net income (loss) available to common stockholders

$ 246

$ 172

$ 342

$ 500

Net income (loss) per common share – basic

$ 0.17

$ 0.12

$ 0.24

$ 0.35

Net income (loss) per common share – assuming
dilution

$ 0.17

$ 0.12

$ 0.24

$ 0.35

Weighted-average shares outstanding

Basic

1,429.7

1,421.3

1,428.8

1,420.0

Assuming dilution

1,437.8

1,432.5

1,438.1

1,431.7

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BOSTON SCIENTIFIC CORPORATION

NON-GAAP NET INCOME AND NET INCOME PER SHARE RECONCILIATIONS

(Unaudited)

Three Months Ended June 30, 2022

(in millions, except per share data)

Gross
Profit

Operating
Expenses

Operating
Income
(Loss)

Other
Income
(Expense)

Income
(Loss)
Before
Income
Taxes

Net
Income
(Loss)

Preferred
Stock
Dividends

Net
Income
(Loss)
Available to
Common
Stockholders

Impact
per
Share (1)

Reported

$ 2,233

$ 1,810

$ 423

$ (78)

$ 345

$ 260

$ (14)

$ 246

$ 0.17

Non-GAAP adjustments:

Amortization expense

(204)

204

204

175

175

0.12

Intangible asset impairment charges

(7)

7

7

7

7

0.00

Acquisition / divestiture-related net

charges (credits)

23

(67)

91

91

95

95

0.07

Restructuring and restructuring-related

net charges (credits)

17

(18)

35

35

30

30

0.02

Litigation-related net charges (credits)

(42)

42

42

33

33

0.02

Investment portfolio net losses (gains)

4

4

2

2

0.00

EU MDR implementation costs

11

(6)

17

17

14

14

0.01

Debt extinguishment charges

0

0

0

0

0.00

Deferred tax expenses (benefits)

34

34

0.02

Discrete tax items

(1)

(1)

(0.00)

Adjusted

$ 2,284

$ 1,466

$ 818

$ (74)

$ 744

$ 649

$ (14)

$ 635

$ 0.44

(1) For the three months ended June 30, 2022, the effect of assuming the conversion of Mandatory Convertible Preferred Stock (MCPS) into shares of common stock was anti-dilutive, and therefore excluded from the calculation of EPS. Accordingly, GAAP net income and adjusted net income were reduced by cumulative Preferred stock dividends, as presented in our unaudited consolidated statements of operations, for purposes of calculating net income available to common stockholders.

Three Months Ended June 30, 2021

(in millions, except per share data)

Gross
Profit

Operating
Expenses

Operating
Income
(Loss)

Other
Income
(Expense)

Income
(Loss)
Before
Income
Taxes

Net
Income
(Loss)

Preferred
Stock
Dividends

Net
Income
(Loss)
Available to
Common
Stockholders

Impact
per
Share (1)

Reported

$ 2,132

$ 1,870

$ 262

$ (113)

$ 149

$ 186

$ (14)

$ 172

$ 0.12

Non-GAAP adjustments:

Amortization expense

(180)

180

180

161

161

0.11

Intangible asset impairment charges

(45)

45

45

39

39

0.03

Acquisition / divestiture-related net charges (credits)

7

70

(63)

(1)

(64)

(65)

(65)

(0.05)

Restructuring and restructuring-related net charges (credits)

22

(16)

39

39

35

35

0.02

Litigation-related net charges (credits)

(298)

298

298

229

229

0.16

Investment portfolio net losses (gains)

6

6

5

5

0.00

EU MDR implementation costs

8

(4)

12

12

11

11

0.01

Deferred tax expenses (benefits)

25

25

0.02

Discrete tax items

(35)

(35)

(0.02)

Adjusted

$ 2,169

$ 1,396

$ 773

$ (107)

$ 665

$ 591

$ (14)

$ 577

$ 0.40

(1) For the three months ended June 30, 2021, the effect of assuming the conversion of Mandatory Convertible Preferred Stock (MCPS) into shares of common stock was anti-dilutive, and therefore excluded from the calculation of EPS. Accordingly, GAAP net income and adjusted net income were reduced by cumulative Preferred stock dividends, as presented in our unaudited consolidated statements of operations, for purposes of calculating net income available to common stockholders.

An explanation of the company’s use of these non-GAAP financial measures is provided at the end of this document.

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BOSTON SCIENTIFIC CORPORATION

NON-GAAP NET INCOME AND NET INCOME PER SHARE RECONCILIATIONS

(Unaudited)

Six Months Ended June 30, 2022

in millions, except per share data

Gross
Profit

Operating
Expenses

Operating
Income
(Loss)

Other
Income
(Expense)

Income
(Loss)
Before
Income
Taxes

Net
Income
(Loss)

Preferred
Stock
Dividends

Net
Income
(Loss)
Available to
Common
Stockholders

Impact
per
Share (1)

Reported

$ 4,304

$ 3,415

$ 889

$ (388)

$ 501

$ 370

$ (28)

$ 342

$ 0.24

Non-GAAP adjustments:

Amortization expense

(402)

402

402

345

345

0.24

Intangible asset impairment charges

(7)

7

7

7

7

0.00

Acquisition / divestiture-related net charges (credits)

50

(112)

163

163

167

167

0.12

Restructuring and restructuring-related

net charges (credits)

35

(29)

64

64

55

55

0.04

Litigation-related net charges (credits)

(42)

42

42

33

33

0.02

Investment portfolio net losses (gains)

11

11

7

7

0.00

EU MDR implementation costs

21

(12)

33

33

28

28

0.02

Debt extinguishment charges

194

194

149

149

0.10

Deferred tax expenses (benefits)

63

63

0.04

Discrete tax items

(0.00)

Adjusted

$ 4,411

$ 2,811

$ 1,599

$ (183)

$ 1,416

$ 1,224

$ (28)

$ 1,197

$ 0.83

(1) For the six months ended June 30, 2022, the effect of assuming the conversion of MCPS into shares of common stock was anti-dilutive, and therefore excluded from the calculation of EPS. Accordingly, GAAP net income and adjusted net income were reduced by cumulative Preferred stock dividends, as presented in our unaudited consolidated statements of operations, for purposes of calculating net income available to common stockholders.

Six Months Ended June 30, 2021

in millions, except per share data

Gross
Profit

Operating
Expenses

Operating
Income
(Loss)

Other
Income
(Expense)

Income
(Loss)
Before
Income
Taxes

Net
Income
(Loss)

Preferred
Stock
Dividends

Net
Income
(Loss)
Available to
Common
Stockholders

Impact
per
Share (1)

Reported

$ 3,990

$ 3,358

$ 632

$ (157)

$ 474

$ 527

$ (28)

$ 500

$ 0.35

Non-GAAP adjustments:

Amortization expense

(365)

365

365

328

328

0.23

Intangible asset impairment charges

(45)

45

45

39

39

0.03

Acquisition / divestiture-related net charges (credits)

21

34

(13)

(199)

(212)

(219)

(219)

(0.15)

Restructuring and restructuring-related net charges (credits)

40

(48)

88

88

79

79

0.05

Litigation-related net charges (credits)

(302)

302

302

233

233

0.16

Investment portfolio net losses (gains)

152

152

117

117

0.08

EU MDR implementation costs

15

(8)

23

23

20

20

0.01

Deferred tax expenses (benefits)

43

43

0.03

Discrete tax items

(38)

(38)

(0.03)

Adjusted

$ 4,066

$ 2,625

$ 1,442

$ (205)

$ 1,237

$ 1,129

$ (28)

$ 1,102

$ 0.77

(1) For the six months ended June 30, 2021, the effect of assuming the conversion of MCPS into shares of common stock was anti-dilutive, and therefore excluded from the calculation of EPS. Accordingly, GAAP net income and adjusted net income were reduced by cumulative Preferred stock dividends, as presented in our unaudited consolidated statements of operations, for purposes of calculating net income available to common stockholders.

An explanation of the company’s use of these non-GAAP financial measures is provided at the end of this document.

BOSTON SCIENTIFIC CORPORATION
Q3 and FY 2022 GUIDANCE RECONCILIATIONS
(Unaudited)

Net Sales

Q3 2022 Estimate

Full Year 2022 Estimate

(Low)

(High)

(Low)

(High)

Reported growth

6.0 %

8.0 %

6.5 %

7.5 %

Less: Impact of foreign currency fluctuations

(4.0) %

(4.0) %

(4.0) %

(4.0) %

Operational growth

10.0 %

12.0 %

10.5 %

11.5 %

Less: Impact of certain acquisitions / divestitures

2.0 %

2.0 %

2.5 %

2.5 %

Organic growth

8.0 %

10.0 %

8.0 %

9.0 %

Earnings per Share

Q3 2022 Estimate

Full Year 2022 Estimate

(Low)

(High)

(Low)

(High)

GAAP results

$ 0.20

$ 0.24

$ 0.69

$ 0.76

Amortization expense

0.12

0.12

0.48

0.48

Acquisition / divestiture-related net charges (credits)

0.05

0.04

0.19

0.18

Restructuring and restructuring-related net charges (credits)

0.03

0.02

0.09

0.07

Litigation-related net charges (credits)

0.02

0.02

Debt extinguishment charges

0.10

0.10

Other adjustments

0.04

0.04

0.15

0.14

Adjusted results

$ 0.43

$ 0.45

$ 1.74

$ 1.77

Use of Non-GAAP Financial Measures

To supplement our unaudited consolidated financial statements presented on a GAAP basis, we disclose certain non-GAAP financial measures, including adjusted net income (loss), adjusted net income (loss) available to common stockholders and adjusted net income (loss) per share (EPS) that exclude certain amounts; operational net sales, which exclude the impact of foreign currency fluctuations; and organic net sales, which exclude the impact of foreign currency fluctuations as well as the impact of certain acquisitions and divestitures with less than a full period of comparable net sales. These non-GAAP financial measures are not in accordance with generally accepted accounting principles in the United States and should not be considered in isolation from or as a replacement for the most directly comparable GAAP financial measures. Further, other companies may calculate these non-GAAP financial measures differently than we do, which may limit the usefulness of those measures for comparative purposes.

To calculate adjusted net income (loss), adjusted net income (loss) available to common stockholders and adjusted net income (loss) per share we exclude certain charges (credits) from GAAP net income (loss) and GAAP net income (loss) available to common stockholders. Amounts are presented after-tax at the company’s effective tax rate, unless the amount is a significant unusual or infrequently occurring item in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic 740-270-30, "General Methodology and Use of Estimated Annual Effective Tax Rate." Please refer to Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations in our most recent Annual Report filed on Form 10-K filed with the Securities and Exchange Commission or any Quarterly Report on Form 10-Q that we file thereafter for an explanation of each of these adjustments and the reasons for excluding each item.

The GAAP financial measures most directly comparable to adjusted net income (loss), adjusted net income (loss) available to common stockholders and adjusted net income (loss) per share are GAAP net income (loss), GAAP net income (loss) available to common stockholders and GAAP net income (loss) per common share – assuming dilution, respectively.

To calculate operational net sales growth rates, which exclude the impact of foreign currency fluctuations, we convert actual net sales from local currency to U.S. dollars using constant foreign currency exchange rates in the current and prior periods. To calculate organic net sales growth rates, we also remove the impact of acquisitions and divestitures with less than a full period of comparable net sales. The GAAP financial measure most directly comparable to operational net sales and organic net sales is net sales on a GAAP basis.

Reconciliations of each of these non-GAAP financial measures to the corresponding GAAP financial measure are included in the accompanying schedules.

Management uses these supplemental non-GAAP financial measures to evaluate performance period over period, to analyze the underlying trends in our business, to assess our performance relative to our competitors and to establish operational goals and forecasts that are used in allocating resources. In addition, management uses these non-GAAP financial measures to further its understanding of the performance of our operating segments. The adjustments excluded from our non-GAAP financial measures are consistent with those excluded from our operating segments’ measures of net sales and profit or loss. These adjustments are excluded from the segment measures reported to our chief operating decision maker that are used to make operating decisions and assess performance.

We believe that presenting adjusted net income (loss), adjusted net income (loss) available to common stockholders, adjusted net income (loss) per share, operational net sales growth rates and organic net sales growth rates, in addition to the corresponding GAAP financial measures, provides investors greater transparency to the information used by management for its operational decision-making and allows investors to see our results "through the eyes" of management. We further believe that providing this information assists our investors in understanding our operating performance and the methodology used by management to evaluate and measure such performance.

Integra LifeSciences Reports Second Quarter 2022 Financial Results

On July 27, 2022 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the second quarter ending June 30, 2022 (Press release, Integra LifeSciences, JUL 27, 2022, View Source [SID1234616987]).

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Second Quarter 2022 Highlights

Second quarter revenues of $398 million increased 2.0% on a reported basis and 4.8% on an organic basis compared to the prior year.
Six-month revenues for 2022 were $774 million and increased 3.3% on a reported basis and 5.2% on an organic basis compared to the prior year.
Second quarter GAAP earnings per diluted share of $0.54, compared to $0.41 in the prior year; adjusted earnings per diluted share of $0.82, compared to $0.79 in the prior year.
The Company entered into an agreement for the sale of its non-core traditional wound care ("TWC") business.
The Company is tightening its previous full-year 2022 organic growth guidance of 3.8% to 5.2% to an updated range of 4.0% to 5.2%, reflecting better than expected first half performance. Full-year 2022 reported revenue guidance is updated to a range of $1,557 million to $1,575 million representing reported growth of 1.0% to 2.1%, inclusive of the planned sale of the TWC business and an updated foreign currency outlook. Adjusted earnings per share guidance range is updated accordingly to $3.21 to $3.29.
"We are pleased with our strong sales performance in the first half of the year. Our balanced portfolio continues to deliver solid, profitable growth in a challenging environment and we are on track to deliver our full-year organic growth expectations," said Jan De Witte, Integra’s president and chief executive officer. "We are encouraged by the momentum we see in our key markets, while our growth initiatives and operational focus further strengthens our ability to deliver on our long-term financial targets."

Second Quarter 2022 Consolidated Performance

Total reported revenues of $397.8 million increased 2.0% on a reported basis and 4.8% on an organic basis compared to the prior year.

The Company reported GAAP gross margin of 62.7%, compared to 61.2% in the second quarter of 2021. Adjusted gross margin was 68.0%, compared to 68.1% in the prior year.

Adjusted EBITDA for the second quarter of 2022 was $102.8 million, or 25.8% of revenue, compared to $101.0 million, or 25.9% of revenue, in the prior year.

The Company reported GAAP net income of $44.8 million, or $0.54 per diluted share, in the second quarter of 2022, compared to a GAAP net income of $35.1 million, or $0.41 per diluted share, in the prior year.

Adjusted net income for the second quarter of 2022 was $68.3 million, or $0.82 per diluted share, compared to $67.4 million, or $0.79 per diluted share, in the prior year.

Second Quarter 2022 Segment Performance

Codman Specialty Surgical (65% of Revenues)

Total revenues were $257.9 million, representing reported growth of 0.4% and organic growth of 4.3% compared to the second quarter of 2021, driven by strength in both Instruments and Neurosurgery. Neurosurgery growth was driven by advanced energy and CSF management.
Tissue Technologies (35% of Revenue)

Total revenues were $140.0 million, representing reported growth of 5.1% and organic growth of 5.9% compared to the second quarter of 2021, driven by Private Label customer orders and growth in Wound Reconstruction and Care led by sales in our Integra Dermal Matrices and SurgiMend
Strategic Initiatives and Key Developments

Advancing key products

Launched the Aurora Evacuator with Coagulation device in the U.S., designed to be used in conjunction with our Aurora Surgiscope to safely address and evacuate blood in the brain caused by hemorrhagic stroke.

Launched the Neutus EVD system, our first external ventricular drain in China. The Neutus EVD system is manufactured in China by Shanghai Haoju Medical Technology Co., Ltd. and commercialized by the Company under an exclusive distribution arrangement. The device is used in the management of cerebrospinal fluid and is highly complementary to our Bactiseal catheter and advanced intercranial pressure monitoring products.

Key developments

Closed a manufacturing facility located in France; transfer of production to the Company’s existing Switzerland facility is in process.

Announced plans to outsource certain transactional back-office finance and customer service activities to enhance customer quality, build scale for future growth, and capture cost efficiencies. The transition is expected to be completed by year end 2022.

Recognized as a Great Place to Work-Certified Organization in China and voted to 2022 Best Places to Work in NJ list.
Balance Sheet, Cash Flow and Capital Allocation

The Company generated cash flow from operations of $66 million in the quarter. Net debt at the end of the quarter was $1.12 billion, and the consolidated total leverage ratio was 2.5x.

As of quarter end, the Company had total liquidity of approximately $1.69 billion, including approximately $447 million in cash and the remainder available under the revolving credit facility.

Divestiture of the Traditional Wound Care Business

On May 20, 2022, the Company signed a definitive agreement to sell its TWC business, which includes sponges, gauze and conforming bandages and advanced wound care dressings, to Gentell, a leading manufacturer and distributor of advanced wound, skin, and personal care products, for $28.8 million, consisting of $27.8 million in cash plus $1.0 million in milestone payments. Revenues for the TWC business were approximately $27 million in 2021.

The transaction is expected to close at or around the end of August 2022, subject to the satisfaction of customary closing conditions.

"Our portfolio optimization actions over the past two years have allowed us to increase our focus on Integra’s core portfolio of market-leading products in neurosurgery, surgical instrumentation and regenerative tissue and moves us closer to achieving our long-term organic growth and profitability targets," said Jan De Witte.

2022 Outlook

For the full year 2022, the Company is tightening its organic growth expectations from a prior range of 3.8% to 5.2% to an updated range of 4.0% to 5.2%. This reflects the strong first half 2022 revenue performance, while also balancing the uncertainty in global markets and continuing supply constraints.

Full year 2022 reported revenue guidance has been revised to a range of $1,557 million to $1,575 million, representing reported growth of 1.0% to 2.1%, to reflect the pending sale of the TWC business and an additional 115 basis points of unfavorable foreign currency impact compared to guidance provided in April 2022. Foreign currency is now expected to unfavorably impact full year reported growth by approximately 225 basis points compared to the prior year due to the continuing strength of the USD compared to other currencies in which we transact sales.

Full year 2022 adjusted earnings per diluted share guidance is updated to a range of $3.21 to $3.29 reflecting the planned divestiture of the TWC business and an updated foreign currency outlook.

For the third quarter 2022, the Company expects reported revenues in the range of $383 million to $391 million, representing reported growth of -1.0 to 1.0% and organic growth of 2.6% to 4.8%. Adjusted earnings per diluted share is expected to be in a range of $0.78 to $0.82. Guidance reflects the impacts from the planned divestiture of the TWC business, as well as an updated foreign currency outlook on reported revenue and adjusted earnings per share.

The Company’s guidance for the third quarter and full year organic sales growth excludes acquisitions and divestitures as well as the effects of foreign currency and the year-over-year change in revenue from discontinued products. Organic growth includes ACell as of January 20, 2022 and excludes sales from the pending TWC divestiture as of September 1, 2022.

Conference Call and Presentation Available Online

Integra has scheduled a conference call for 8:30 a.m. ET on Wednesday, July 27, 2022, to discuss second quarter 2022 financial results, and forward-looking financial guidance. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question-and-answer session following the call. Integra’s management team will reference a presentation during the conference call, which can be found on the Investor section of the website at investor.integralife.com.

Access to the live call is available by dialing (800) 289-0720 and using the passcode 2688312. A simultaneous webcast of the call will be available via the Company’s website at www.integralife.com. A webcast replay of the call can be accessed through the Investor Relations homepage of Integra’s website at www.integralife.com. A replay of the call will be available until August 7, 2022 by dialing (888) 203-1112 and using the passcode 2688312 .

Versant Ventures Collaborates with AbCellera to Accelerate Drug Development for its Portfolio of Biotech Companies

On July 27, 2022 AbCellera (Nasdaq: ABCL) and Versant Ventures reported a multi-year collaboration to discover therapeutic antibodies for multiple targets selected by Versant’s portfolio of biologics-focused biotechs (Press release, AbCellera, JUL 27, 2022, View Source [SID1234617005]). Versant and AbCellera already have enabled three of the firm’s stealth-stage companies under previous partnerships.

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Under the terms of the deal, Versant portfolio companies will have rights to develop and commercialize the resulting therapeutic antibodies. AbCellera will receive research payments from the companies and will be eligible to receive downstream clinical and commercial milestone payments plus royalties on net sales of products. Further terms are not disclosed.

"In recent years we have made a series of investments into the next generation of therapeutic antibodies," said Markus Enzelberger, Ph.D., a partner at Versant. "We are seeing a wave of innovation in the antibody space that is allowing us to add novel functionalities to these molecules. Our partnership with AbCellera will further enable our portfolio companies to pursue these important biologic medicines."

"AbCellera’s discovery technology provides a complete solution for antibody therapeutics that unlocks new opportunities and levels the playing field for smaller companies, allowing them to advance programs faster, more efficiently and with a competitive advantage," said Carl Hansen, Ph.D., CEO and President of AbCellera. "We are excited to deepen our relationship with the Versant team and look forward to helping them continue a strong track record of bringing together breakthrough science, experienced teams, and capital to create bold new biotech companies."

Previously, Versant and AbCellera partnered in separate multi-target deals to enable three of the firm’s stealth-stage companies with new approaches to optimize and expand antibody therapies. These include antibody-focused newcos in the fields of immunology and oncology based in Canada, the U.S. and Europe.

Xencor to Host Second Quarter 2022 Financial Results Webcast and Conference Call on August 3, 2022

On July 27, 2022 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported it will release second quarter 2022 financial results after the market closes on Wednesday, August 3, 2022 (Press release, Xencor, JUL 27, 2022, View Source [SID1234617021]).

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Xencor management will host a webcast and conference call the same day at 4:30 p.m. ET (1:30 p.m. PT) to discuss the financial results and provide a corporate update.

The live webcast will be available under "Events & Presentations" in the Investors section of the Company’s website located at investors.xencor.com and will be archived for at least 30 days. Participants may register for the conference call at the following link: register.vevent.com/register/BI8b3886bf9772414c8dd5900d3aa4457b.