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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"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.

SHINE Submits Drug Master File for n.c.a. Lu-177

On July 27, 2022 SHINE Technologies, LLC (SHINE), a next-generation nuclear technology company, reported the company has submitted a Drug Master File (DMF) with the U.S. Food and Drug Administration for non-carrier-added lutetium-177 (Lu-177) chloride, a radiopharmaceutical at the forefront of precision cancer treatment (Press release, Shine Medical Technologies, JUL 27, 2022, View Source [SID1234618509]).

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In targeted cancer therapy, the cancer-killing radioisotope Lu-177 is paired with a cancer-seeking molecule to form a smart compound that directly targets and attacks cancer cells.

SHINE is the emerging leader in the production of this medical radioisotope. With its proprietary technology, SHINE intends to be the industry’s only vertically integrated producer of Lu-177, providing a reliable and scalable supply without the need for aging nuclear reactors.

The DMF submission provides confidential detailed information about facilities, procedures, or articles used in the manufacturing, processing, and storing of drugs. It is a clear commitment to the several companies that have requested letters of authorization to access SHINE’s drug master file in support of their clinical trials which are underway to fight cancer. And it is also an important step in SHINE’s path to meeting the increasing global demand for Lu-177.

"As global demand for lutetium-177 increases, SHINE is poised to scale our operations and be the preferred partner for customers seeking a high-quality, reliable supply of lutetium-177," said Chris Vessell, general manager of SHINE’s Therapeutics Division.

"We’ve been producing lutetium-177 that meets or exceeds customer specifications for some time now, and the DMF submittal represents the next step in getting our product into regular commercial use." said Greg Piefer, founder and CEO of SHINE Technologies. "We’re looking forward to growing our vertically-integrated and sustainable process to ensure the world has scalable access to these game-changing, cancer-destroying products as new therapies are approved."

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]):

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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].

Nuvectis Pharma, Inc. Announces Approximately $15.9 Million Private Placement

On July 27, 2022 Nuvectis Pharma, Inc (Nasdaq: NVCT) ("Nuvectis" or the "Company"), a biopharmaceutical company focused on the development of precision medicines for serious conditions of unmet medical need in oncology, reported that it has entered into definitive agreements with healthcare-focused institutional and accredited investors for the issuance and sale of 1,924,689 shares of common stock (or pre-funded warrants in lieu thereof) at a purchase price of $8.25 per share and preferred investment option (Press release, Nuvectis Pharma, JUL 27, 2022, View Source [SID1234617156]). The investors also purchased preferred investment options to purchase up to an aggregate of 1,924,689 shares of common stock. The preferred investment options will have an exercise price of $9.65, will become exercisable commencing six months following date of issuance and will have a term of three and one-half years from the date of issuance.

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Gross proceeds to Nuvectis from the offering are expected to be approximately $15.9 million, before deducting placement agent fees and other offering expenses payable by the Company.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the private placement.

The closing of the private placement is expected to occur on or about July 29, 2022, subject to the satisfaction of customary closing conditions. Nuvectis intends to use the net proceeds from the private placement for working capital and general corporate purposes

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Under an agreement with the investors, the Company agreed to file an initial registration statement with the Securities and Exchange Commission covering the resale of the shares of common stock to be issued to the investors (including the shares of common stock issuable upon the exercise of the preferred investment options and pre-funded warrants).

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Beyond Air® Schedules First Fiscal Quarter 2023 Financial Results Conference Call and Webcast

On July 27, 2022 Beyond Air, Inc. (NASDAQ: XAIR), a medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, reported that it will report financial results for its first fiscal quarter ended June 30, 2022 on Thursday, August 11, 2022 (Press release, Beyond Air, JUL 27, 2022, View Source [SID1234617097]). The Company’s management team is scheduled to host a conference call and webcast at 4:30 pm Eastern Time the same day.

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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

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