Press Release: Strong execution in Q2 drives full-year 2022 guidance upgrade and delivers rich R&D news flow in Immunology and Rare Disease

On July 28, 2022 Sanofi reported that Q2 2022 sales growth of 8.1% at CER driven by Dupixent, Rare Disease, Vaccines and CHC (Press release, Sanofi, JUL 28, 2022, View Source [SID1234617046])

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Specialty Care grew 21.6% driven by Dupixent (€1,963 million, +43.4%), and double-digit growth in Rare Disease
Vaccines up 8.7% due to strong rebound of Travel and Booster vaccines as well as continued PPH franchise growth
General Medicines achieved 6.0% growth in core assets despite lower COVID-19 related demand for Lovenox
CHC delivered 5th consecutive quarter of growth (+9.1%) driven by Cough & Cold, Allergy and Digestive Wellness
Q2 2022 business EPS(1) up 16.7% at CER driven by higher sales and improving margins

BOI margin up 1.3 ppt to 27.2% due to margin improvement from efficiency gains and EUROAPI deconsolidation
€2.6bn savings achieved at the end of Q2, with the majority reinvested in growth drivers and R&D
Business EPS(1) of €1.73, up 25.4% on a reported basis and 16.7% at CER
IFRS EPS of €0.94 (down 2.1%)
Progress on Corporate Social Responsibility strategy

Sanofi’s Global Health Unit launches a fund for healthcare solutions in underserved regions and Impact, a new brand dedicated for non-profit distribution of 30 Sanofi products to at-risk populations in 40 lower-income countries
Valyou program continues to improve access through lower out-of-pocket cost of insulins for uninsured patients in the U.S.
Sanofi upgraded its scope 3 GHG emission reductions ambition to -30% by 2030, unveiling low energy intensity vaccines facility
Key milestone and regulatory achievements on R&D transformation

Efanesoctocog alfa, the first factor VIII therapy to be granted FDA Breakthrough Therapy Designation for hemophilia A
Dupixent approved in the U.S as first treatment for adults and children aged 12 and older with eosinophilic esophagitis and as first biologic medicine for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis
FDA accepted Dupixent for priority review in adults with prurigo nodularis
Nexviadyme and XenpozymeTM approved in EU
Next-generation COVID-19 booster demonstrated strong results against variants of concern, including Omicron
Full-year 2022 business EPS guidance revised upward

Sanofi now expects 2022 business EPS(1) to grow approximately 15%(2) at CER, barring unforeseen major adverse events. Applying average July 2022 exchange rates, the positive currency impact on 2022 business EPS is estimated between +7.5% to +8.5%
Sanofi Chief Executive Officer, Paul Hudson, commented:

"Our performance in the second quarter was again marked by higher sales across our key growth drivers and outstanding financial results leading us to upgrade our business EPS guidance for the full-year. Notably, we saw significant growth momentum from our Specialty Care business, mainly driven by Dupixent. While we continue to increase our investment in R&D, we delivered important pipeline milestones such as the approval of Dupixent in its fourth disease indication, Eosinophilic Esophagitis. Earlier this month, we had the opportunity to showcase at ISTH the transformative potential of efanesoctocog alfa, the first factor replacement therapy for hemophilia A to receive FDA Breakthrough Therapy Designation. We are also making great progress in advancing our fully integrated social impact strategy, notably in Affordable Access with the launch of Impact, a dedicated brand for non-profit distribution to enable the secure distribution of 30 Sanofi medicines in 40 lower-income countries. As we continue to deliver ahead of schedule on our Play to Win strategy, we are confident in our business outlook for the second half and as a result, we are reiterating our commitment to achieving the BOI margin target of 30% in 2022."

Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 9). (1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (definition in Appendix 9). The consolidated income statement for Q2 2022 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) 2021 business EPS was €6.56; (3) Free cash flow is a non-GAAP financial measure (definition in Appendix 9).

Fresenius revises FY/22 Group guidance driven by significantly worsening headwinds at Fresenius Medical Care – Outlook confirmed for Fresenius Kabi, Fresenius Helios and Fresenius Vamed

On July 28, 2022 Fresenius Medical Care reported it’s financial performance in Q2/22 was significantly impacted by worsened labor shortages and related meaningfully increased wage inflation in the U.S (Press release, Fresenius, JUL 28, 2022, View Source [SID1234617045]). The further deterioration of the macro-economic environment resulted in accelerated non-wage inflation, particularly higher supply chain costs.

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Against this backdrop and growing indications for a persistent unfavorable development of these and other factors, Fresenius Medical Care has revised its outlook for FY/22.

All other Fresenius Group segments confirm their respective outlook for FY/22 for both revenue and EBIT.

However, as a consequence of the development at Fresenius Medical Care, and despite all other Fresenius Group segments confirming their respective outlook for both revenue and EBIT, Fresenius now also revises its Group outlook for FY/22. At constant currency, the Company now anticipates Group sales1 to grow in a low-to-mid single-digit percentage range (previously: mid-single digit percentage range) and Group net income2,3 to decline in a low-to-mid single-digit percentage range (previously: increase in a low-single-digit percentage range).

1 FY/21 base: €37,520 million
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA
3 FY/21 base: €1,867 million; before special items; FY/22: before special items

Stephan Sturm, CEO of Fresenius, said: "As a globally active healthcare group, we, too, have inevitably been impacted by – in many cases massive – cost increases, growing problems in the global supply chains, and staff shortages. And unlike companies in other industries, we cannot simply pass on the resulting cost burdens in the short term by raising our prices. To the extent possible and foreseeable, we factored these burdens into the guidance we provided in February and May. In the meantime, though, it has become apparent that patient-facing healthcare services in the United States are affected even more heavily, hence also Fresenius Medical Care. It will take fortitude and energy to overcome this particularly challenging phase, and I am therefore very pleased that Carla Kriwet will assume her new position as CEO of Fresenius Medical Care quite a bit earlier than initially planned. I am confident that, together with her colleagues, she will find the right solutions and lead Fresenius Medical Care into a successful future."

"Our goal at Fresenius is, and remains, to create more value: for our patients, our employees and our shareholders," added Sturm. "We are working tirelessly, guided by our clear strategic priorities, to achieve this. And we continue to see good prospects, despite the current burdens and difficulties resulting from global crises. Not least because, from our strong market positions, we moved early to capitalize on the right trends, such as home dialysis. Healthcare is a market of the future that we want to play an important role in shaping, and where we intend to continue our sustained, profitable growth."

Assumptions for guidance FY/22
Due to the meaningfully increased uncertainty and volatility related to the war in Ukraine, the ongoing impacts of the COVID-19 pandemic, and a rapidly worsening global macro-economic development, Fresenius now expects significantly more pronounced headwinds in 2022 from supply chain disruptions and cost inflation, including energy prices. Furthermore, Fresenius expects significant negative effects from ongoing labor shortages and associated wage inflation, especially at Fresenius Medical Care in the U.S.

The war in Ukraine is directly and indirectly affecting Fresenius Group operations. The direct adverse effects of the war amounted to €20 million at net income1 level of Fresenius Group in H1/22 and are treated as a special item. Fresenius will continue to closely monitor the potential further consequences of the war, including balance sheet valuations. The guidance does not consider a significant disruption of gas or electricity supplies in Europe.

COVID-19 will continue to impact Fresenius Group operations in 2022. An unlikely but possible significant deterioration of the situation triggering containment measures that could have a significant and direct impact on the health care sector without any appropriate compensation is not reflected in the Group’s FY/22 guidance.

Furthermore, the updated assumptions for Fresenius Medical Care’s FY/22 guidance are also fully applicable to Fresenius Group’s FY/22 guidance. All of these assumptions are subject to considerable uncertainty. The acquisition of Ivenix and the announced acquisition of the majority stake in mAbxience as well as any further potential acquisitions remain excluded from guidance.

1 Net income attributable to shareholders of Fresenius SE & Co. KGaA

Group medium-term targets
As a result of the updated expectations for FY/22, Fresenius now believes its medium-term net income1 target is no longer achievable. Fresenius had expected Group organic net income1 growth to be at the bottom end of the 5% to 9% compounded annual growth rate (CAGR) range for 2020 to 2023. At the same time, Fresenius specifies its Group organic sales growth target to reach the low-end of the targeted 4% to 7% compounded annual growth rate (CAGR) range for 2020 to 2023.

Cost and efficiency program
The Group’s cost and efficiency program is running according to plan and Fresenius confirms its increased savings targets provided in February 2022 of at least €150 million p.a. after tax and minority interest in 2023. For the years thereafter, a further significant increase in sustainable cost savings is expected.

Management Board change at Fresenius Medical Care
Dr. Carla Kriwet will now join Fresenius Medical Care as CEO on October 1, 2022, earlier than previously announced and Rice Powell will step down as CEO effective September 30, 2022.

Preliminary Q2 and H1/22 results2

1 Net income attributable to shareholders of Fresenius SE & Co. KGaA
2 EBIT and net income before special items
3 Excluding Ivenix acquisition

Fresenius Kabi preliminary financial results
Sales in Q2/22 increased by 8% (2% in constant currency) to €1,896 million (Q2/21: €1,755 million). Organic growth was 2%. The positive currency translation effects of 6% in Q2/22 were mainly related to the U.S. dollar and Chinese yuan.

Sales in North America increased by 16% (organic growth: 3%) to €606 million (Q2/21: €522 million), strongly supported by U.S. Dollar-related currency translation effects. Sales in Europe increased by 4% (organic growth: 4%) to €658 million (Q2/21: €634 million). Sales in Asia-Pacific increased by 4% (organic growth: -4%) to €425 million (Q2/21: €409 million). Positive currency translation effects contributed to reported sales growth. Sales in Latin America/Africa increased by 9% (organic growth: 2%) to €207 million (Q2/21: €190 million). Sales for the Biosimilars business were €29 million.

EBIT1 decreased by 9% (-15%2 in constant currency) to €271 million (Q2/21: €298 million). The EBIT margin1 was 14.3% (Q2/21: 17.0%).

Fresenius Kabi EBIT by region

Fresenius Kabi confirms its FY/22 outlook and expects organic sales3 growth in a low-single-digit percentage range. Constant currency EBIT2,4 is expected to decline in a high-single- to low-double-digit percentage range. The sales and EBIT outlook ranges include expected COVID-19 effects and exclude the effects of the acquisitions Ivenix and mAbxience.

1 Before special items
2 Excluding Ivenix acquisition
3 FY/21 base: €7,193 million
4 FY/21 base: €1,153 million, before special items, FY/22 before special items

Fresenius Helios preliminary financial results
Sales increased by 7% (6% in constant currency) to €2,925 million (Q2/21: €2,738 million). Organic growth was 5%. Acquisitions contributed 1% to sales growth.

Sales of Helios Germany increased by 5% (organic growth: 4%) to €1,758 million (Q2/21: €1,675 million). Sales of Helios Spain increased by 8% (7% in constant currency) to €1,101 million (Q2/21: €1,020 million). Organic growth was 6%. Sales of Helios Fertility were €65 million (Q2/21: €42 million).

EBIT1 of Fresenius Helios increased by 2% (1% in constant currency) to €303 million (Q2/21: €298 million) with an EBIT margin1 of 10.4% (Q2/21: 10.9%).

EBIT of Helios Germany increased by 1% to €154 million (Q2/21: €152 million) with an EBIT margin of 8.8% (Q2/21: 9.1%). EBIT of Helios Spain increased by 1% (0% in constant currency) to €148 million (Q2/21: €147 million). The EBIT margin was 13.4% (Q2/21: 14.4%). EBIT1 of Helios Fertility was €7 million with an EBIT1 margin of 10.8% (Q2/21: €5 million).

Fresenius Helios confirms its FY/22 outlook and expects organic sales2 growth in a low- to mid-single-digit percentage range and constant currency EBIT3 growth in a mid-single-digit percentage range. The sales and EBIT outlook ranges include expected COVID-19 effects.

Fresenius Vamed preliminary financial results
Sales increased by 1% (1% in constant currency) to €562 million (Q2/21: €556 million). Organic growth was 1%.
Sales in the service business increased by 6% (6% in constant currency) to €417 million (Q2/21: €392 million). Sales in the project business decreased by 12% (-12% in constant currency) to €145 million (Q2/21: €164 million).
EBIT1 decreased by 31% to €11 million (Q2/21: €16 million) with an EBIT margin1 of 2.0% (Q2/21: 2.9%).
Order intake was €253 million (Q2/21: €713 million). As of June 30, 2022, order backlog was at €3,732 million (December 31, 2021: €3,473 million).

Fresenius Vamed confirms its FY/22 outlook and expects organic sales4 growth in a high-single to low-double-digit percentage range and constant currency EBIT5 to return to absolute pre-COVID-19 levels (FY/19: €134 million). The sales and EBIT outlook ranges include expected COVID-19 effects.

1 Before special items
2 FY/21 base: €10,891 million
3 FY/21 base: €1,127 million, before special items, FY/22 before special items
4 FY/21 base: €2,297 million
5 FY/21 base: €101 million, before special items; FY/22 before special items

Detailed financial results publication and Conference Call
As part of the publication of the preliminary results for Q2/2022, a conference call will be held on July 28, 2022 at 1:30 p.m. CEDT (7:30 a.m. EDT) replacing the originally planned call from August 2, 2022.

All investors are cordially invited to follow the conference call in a live broadcast over the Internet at www.fresenius.com/investors. Following the call, a replay will be available on our website.

On August 2, 2022, Fresenius will publish detailed Q2/22 and H1/22 financials.

Quarterly Activities Report & 4C – 30 June 2022

On July 28, 2022 Patrys reported its Quarterly Activities Report and Appendix 4C Quarterly Cash Flow report for the quarter ended 30 June 2022 (Press release, Patrys, JUL 28, 2022, View Source [SID1234617044]).

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During the last quarter, Patrys has made substantial progress in expanding the base of evidence to support the range of potential clinical applications for its deoxymabs.

Key achievements include:

$250,000 non-dilutive funding to support research by the Telethon Kids’ Institute into potential therapeutic applications for Patrys’ deoxymabs;
New research published showing potential to use PAT-DX1 to regulate Neutrophil Extracellular Traps that play a role in cancer metastasis and inflammation;
Update on research collaboration with Imagion to develop new targeted antibody-based imaging agents for brain cancer;
Our Company holds a strong financial position, with a closing cash balance of $7.8M at 30 June 2022, with an additional $2M in short-term investments.

Cortexyme Corporate Name Change to Quince Therapeutics to Take Effect on August 1, 2022

On July 27, 2022 Cortexyme, Inc. (Nasdaq: CRTX) reported that the company’s planned corporate name change to Quince Therapeutics is expected take effect on Monday, August 1, 2022 (Press release, Quince Therapeutics, JUL 27, 2022, View Source [SID1234619482]). In conjunction with the corporate name change, the company plans to issue a news release that will provide a business update detailing Quince Therapeutics’ go-forward growth strategy and development pipeline plans.

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Additionally, the company’s ticker symbol on the Nasdaq Global Select Market is expected change to "QNCX" effective at the open of market trading on Monday, August 1, 2022. The company’s common stock will continue to trade under the ticker symbol "CRTX" until market close on Friday, July 29, 2022. The corporate name change to Quince Therapeutics does not affect the rights of the company’s stockholders. Outstanding stock certificates are not affected by the name change and will not need to be exchanged.

Quince Therapeutics also plans to launch its new corporate website and social media presence on Twitter and LinkedIn on Monday, August 1, 2022.

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.