On October 27, 2022 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported its consolidated financial results for the third quarter ended September 30, 2022 and reviewed recent business highlights (Press release, Alnylam, OCT 27, 2022, View Source [SID1234622451]).

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"The third quarter of 2022 was one of strong execution across our commercial and clinical development operations. AMVUTTRA has completed its first full quarter on the market since its U.S. approval and launch in June and is off to a great start, demonstrating the potential of our RNAi therapeutics portfolio in patients with hATTR amyloidosis with polyneuropathy which achieved 30% U.S. growth compared to Q2. We’re also looking forward to potentially expanding the opportunity for this franchise and are encouraged by the positive APOLLO-B Phase 3 results for patisiran in patients with ATTR amyloidosis with cardiomyopathy presented recently. We are on track to submit an sNDA for ONPATTRO by year-end and hope to bring this treatment option to patients in 2023 assuming successful regulatory review and approval," said Yvonne Greenstreet, MBChB, Chief Executive Officer of Alnylam. "The rest of our pipeline continues to progress well, and we are excited for several important upcoming milestones, including results for a potential biannual dose regimen for vutrisiran, preliminary Phase 1 results for ALN-XDH in patients with gout, completion of enrollment in the KARDIA-2 Phase 2 study of zilebesiran, and initiation of a Phase 1 study of ALN-TTRsc04 in healthy volunteers. We are encouraged by our steady and continuous execution on all fronts, and believe we are on track to achieve our Alnylam P5x25 goals and become a top-tier biotech company."

Third Quarter 2022 and Recent Significant Corporate Highlights

Commercial Performance

Total TTR: ONPATTRO (patisiran) & AMVUTTRA (vutrisiran)

Achieved global net product revenues for ONPATTRO and AMVUTTRA for the third quarter of 2022 of $145 million and $25 million, respectively, representing a total TTR increase of 11% compared to Q2 2022, with the U.S. market contributing 30% total TTR growth underpinned by the strength of the AMVUTTRA launch.
Attained over 2,580 hATTR amyloidosis patients with polyneuropathy worldwide on commercial treatment with ONPATTRO or AMVUTTRA as of September 30, 2022, up from over 2,400 on commercial ONPATTRO as of June 30, 2022, representing 8% total TTR quarterly growth.
Received 475 Start Forms in the U.S. for AMVUTTRA from launch through September 30, 2022, with 46% representing new patients and 54% representing patients switching from ONPATTRO.
GIVLAARI (givosiran)

Achieved global net product revenues for the third quarter of 2022 of $46 million, representing a 1% increase compared to Q2 2022.
Attained over 460 patients worldwide on commercial GIVLAARI treatment as of September 30, 2022, up from over 420 commercial patients as of June 30, 2022, representing 10% quarterly growth.
OXLUMO (lumasiran)

Achieved global net product revenues for the third quarter of 2022 of $16 million, representing a 10% increase compared to Q2 2022.
Attained over 230 patients worldwide on commercial OXLUMO treatment as of September 30, 2022, up from over 200 commercial patients as of June 30, 2022, representing 15% quarterly growth.
Leqvio (inclisiran)

Launch in the U.S. and other markets is ongoing, with focus on patient onboarding, removing access hurdles and enhancing medical education.
R&D Highlights

Patisiran (the non-proprietary name for ONPATTRO), in development for the treatment of ATTR amyloidosis.

Reported positive results from the APOLLO-B Phase 3 study in patients with ATTR amyloidosis with cardiomyopathy. The Company remains on track to submit an sNDA for review by the United States Food and Drug Administration (FDA) by year-end.
Vutrisiran (the non-proprietary name for AMVUTTRA), in development for the treatment of ATTR amyloidosis.

Received marketing authorization for AMVUTTRA for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adults with stage 1 or stage 2 polyneuropathy in Europe and the UK, as well as approval for transthyretin (TTR) type familial amyloidosis with polyneuropathy in Japan.
Alnylam announces today that it does not plan to conduct the optional interim analysis for the HELIOS-B Phase 3 study in patients with ATTR amyloidosis with cardiomyopathy. The study remains on track for topline results in early 2024.
The Company also announces today that it is considering options for the best path toward advancing an RNAi therapeutic for the treatment of Stargardt Disease. At this time, it will not initiate a Phase 3 study of vutrisiran in Stargardt Disease in late 2022, as previously guided, as it continues to evaluate the impact of the Inflation Reduction Act.
Lumasiran (the non-proprietary name for OXLUMO), for the treatment of primary hyperoxaluria type 1 (PH1), and in development for the treatment of recurrent kidney stone disease.

Based on the successful outcome of the ILLUMINATE-C study in children and adults with advanced PH1, received approval from the U.S. FDA of an sNDA for OXLUMO, expanding the indication for the treatment of PH1 to lower urinary oxalate and plasma oxalate levels in pediatric and adult patients, and received approval from the European Medicines Agency (EMA) of a Type II variation to include the ILLUMINATE-C data in the label.
Cemdisiran, in development for the treatment of complement-mediated diseases, in collaboration with Regeneron.

Reported positive results from the Phase 2 study in patients with immunoglobulin A nephropathy (IgAN).
Alnylam is working with Regeneron to finalize plans for the Phase 3 clinical development of cemdisiran in IgAN.
Early- and mid-stage investigational RNAi therapeutic pipeline programs and RNAi platform

Published preclinical results in Nature Biotechnology based on novel conjugate technology facilitating delivery of siRNA to the CNS and other extrahepatic tissues.
Vir Biotechnology announced that the first patient has been dosed in the Phase 2 SOLSTICE clinical trial evaluating ALN-HBV02 (VIR-2218) and VIR-3434 as monotherapy and in combination for the treatment of people living with chronic hepatitis D virus (HDV), which occurs as a simultaneous co-infection or super-infection alongside hepatitis B virus (HBV).
Published research findings in Nature Communications identifying mutations in the INHBE gene associated with protection against abdominal obesity and metabolic syndrome.
Reported preliminary data from the ongoing Phase 1 study of ALN-HSD, in development for the treatment of nonalcoholic steatohepatitis (NASH).
Alnylam announces today that enrollment and dose escalation continue in the Phase 1 study of ALN-APP in patients with early onset Alzheimer’s Disease, in collaboration with Regeneron, and initial results are now expected in early 2023.
Filed a Clinical Trial Application (CTA) for ALN-TTRsc04, the first clinical program from the Company’s IKARIA platform, aimed at achieving an annual dosing regimen with highly potent and reversible effects of TTR lowering.
Additional Business Updates

Appointed Piyush Sharma as Chief Ethics and Compliance Officer and Evan Lippman as Chief Corporate Development and Strategy Officer.
Issued $1,035 million convertible senior notes with proceeds primarily used to pay down Blackstone $700 million credit facility and approximately $200 million in prepayment premiums under the credit facility, the purchase of capped call transactions, and underwriter fees.
Ranked #1 on Fast Company’s fourth annual list of Best Workplaces for Innovators.
Named a Top Place to Work for Women by Fortune magazine.
Upcoming Events

In late 2022, Alnylam intends to:

Present a review of its pipeline and platform activities at its upcoming R&D Day being held virtually on Thursday, December 15, 2022.
Submit an sNDA to the FDA for review for ONPATTRO for the treatment of patients with ATTR amyloidosis with cardiomyopathy.
Report results on a biannual dose regimen for vutrisiran.
Initiate a Phase 1 study for ALN-TTRsc04 in healthy volunteers.
Complete enrollment in the Phase 2 study of lumasiran in patients with recurrent renal stones.
Complete enrollment in the KARDIA-2 Phase 2 study of zilebesiran (at or around year-end).
Report preliminary results from the Phase 1 study of ALN-XDH in patients with gout.
Submit CTA filings for ALN-KHK for the treatment of metabolic liver disease, including diabetes, and in collaboration with its partner Regeneron, submit an IND for ALN-PNP for the treatment of NASH.

CER = Constant Exchange Rate, representing growth calculated as if the exchange rates had remained unchanged from those used in the third quarter 2021. CER is a Non-GAAP measure.

Net product revenues increased 39% at actual currency during the third quarter of 2022, as compared to the prior year, and 49% at CER. The increase is primarily due to increased patients on ONPATTRO, AMVUTTRA, GIVLAARI, and OXLUMO.
Net Revenues from Collaborations

Net revenues from collaborations increased 45% during the third quarter 2022, as compared to the prior year, primarily due to an increase in revenue from our collaboration with Regeneron resulting from the timing of reimbursable activities.

Research & Development (R&D) Expenses

GAAP and non-GAAP R&D expenses increased during the third quarter 2022, as compared to the prior year, primarily due to increases in headcount to support our R&D pipeline and development expenses associated with the KARDIA-1 and KARDIA-2 zilebesiran Phase 2 studies, offset by a decrease in the cost of clinical batches manufactured during the quarter. GAAP R&D expenses further increased due to increased stock-based compensation expense related to the accounting for certain performance-based awards that vested during the period.
Selling, General & Administrative (SG&A) Expenses

GAAP and non-GAAP SG&A expenses increased during the third quarter 2022, as compared to the prior year, primarily due to increased headcount and other strategic investments in support of the U.S. AMVUTTRA launch and other corporate purposes. GAAP SG&A expenses further increased due to stock-based compensation expense related to the accounting for certain performance-based awards that vested during the period.
Other Financial Highlights

GAAP Other expense, net, increased during the third quarter 2022 as compared to the prior year, primarily due to a $77 million loss on the extinguishment of the Blackstone credit agreement and a $25 million loss from the fair value adjustment on the development derivative liability.
Cash, cash equivalents and marketable securities were $2.27 billion as of September 30, 2022 compared to $2.44 billion as of December 31, 2021 with the decrease primarily due to our year-to-date operating loss in 2022. This decrease was largely offset by approximately $200 million received from employee option award exercises and approximately $135 million received from the issuance of convertible debt, net of repayment of borrowings, inclusive of prepayment premiums under the credit facility, the purchase of capped call transactions, and underwriter fees.
A reconciliation of our GAAP to non-GAAP results for the current quarter is included in the tables of this press release.

1 Prior FY 2022 guidance utilized April 18, 2022 FX rates of: 1 EUR = 1.08 USD; 1 GBP = 1.31 USD; 1 CHF = 1.06 USD; 1 CAD = 0.79 USD, 1 USD = 126 JPY

2 Updated FY 2022 guidance utilizes September 27, 2022 FX rates of: 1 EUR = 0.96 USD; 1 GBP = 1.08 USD; 1 CHF = 1.01 USD; 1 CAD = 0.73 USD, 1 USD = 145 JPY

3 Primarily excludes $230-$250 million of stock-based compensation expense from estimated GAAP R&D and SG&A expenses.

Use of Non-GAAP Financial Measures
This press release contains non-GAAP financial measures, including expenses adjusted to exclude certain non-cash expenses and non-recurring gains outside the ordinary course of the Company’s business. These measures are not in accordance with, or an alternative to, GAAP, and may be different from non-GAAP financial measures used by other companies.

The items included in GAAP presentations but excluded for purposes of determining non-GAAP financial measures for the periods presented in this press release are stock-based compensation expenses, realized and unrealized (gains) losses on marketable equity securities and loss on the extinguishment of debt. The Company has excluded the impact of stock-based compensation expense, which may fluctuate from period to period based on factors including the variability associated with performance-based grants for stock options and restricted stock units and changes in the Company’s stock price, which impacts the fair value of these awards. The Company has excluded the impact of the realized and unrealized (gains) losses on marketable equity securities because the Company does not believe these adjustments accurately reflect the performance of the Company’s ongoing operations for the period in which such gains or losses are reported, as their sole purpose is to adjust amounts on the balance sheet. The Company has excluded the loss on the extinguishment of debt because the Company believes the item is a non-recurring transaction outside the ordinary course of the Company’s business.

Percentage changes in revenue growth at CER are presented excluding the impact of changes in foreign currency exchange rates for investors to understand the underlying business performance. The current period’s foreign currency revenue values are converted into U.S. dollars using the average exchange rates from the prior period.

The Company believes the presentation of non-GAAP financial measures provides useful information to management and investors regarding the Company’s financial condition and results of operations. When GAAP financial measures are viewed in conjunction with non-GAAP financial measures, investors are provided with a more meaningful understanding of the Company’s ongoing operating performance and are better able to compare the Company’s performance between periods. In addition, these non-GAAP financial measures are among those indicators the Company uses as a basis for evaluating performance, allocating resources and planning and forecasting future periods. Non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between GAAP and non-GAAP measures is provided later in this press release.

Conference Call Information
Management will provide an update on the Company and discuss third quarter 2022 results as well as expectations for the future via conference call on Thursday, October 27, 2022 at 8:30 am ET. To access the call, please register online at https://register.vevent.com/register/BI1581caadac4f4c80820e2eb8a001b2c3. Participants are requested to register at a minimum 15 minutes before the start of the call. A replay of the call will be available two hours after the call and archived on the same web page for six months.

A live audio webcast of the call will be available on the Investors section of the Company’s website at www.alnylam.com/events. An archived webcast will be available on the Alnylam website approximately two hours after the event.

About ONPATTRO (patisiran)
ONPATTRO is an RNAi therapeutic that is approved in the United States and Canada for the treatment of the polyneuropathy of hATTR amyloidosis in adults. ONPATTRO is also approved in the European Union, Switzerland and Brazil for the treatment of hATTR amyloidosis in adults with Stage 1 or Stage 2 polyneuropathy, and in Japan for the treatment of hATTR amyloidosis with polyneuropathy. ONPATTRO is an intravenously administered RNAi therapeutic targeting transthyretin (TTR). It is designed to target and silence TTR messenger RNA, thereby reducing the production of TTR protein before it is made. Reducing the pathogenic protein leads to a reduction in amyloid deposits in tissues. For more information about ONPATTRO, including full Prescribing Information, visit ONPATTRO.com.

About GIVLAARI (givosiran)
GIVLAARI is an RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) approved in the United States and Brazil for the treatment of adults with acute hepatic porphyria (AHP). GIVLAARI is also approved in the European Union for the treatment of AHP in adults and adolescents aged 12 years and older. In the pivotal study, givosiran was shown to significantly reduce the rate of porphyria attacks that required hospitalizations, urgent healthcare visits or intravenous hemin administration at home compared to placebo. GIVLAARI is Alnylam’s first commercially available therapeutic based on its Enhanced Stabilization Chemistry ESC-GalNAc conjugate technology to increase potency and durability. GIVLAARI is administered via subcutaneous injection once monthly at a dose based on actual body weight and should be administered by a healthcare professional. GIVLAARI works by specifically reducing elevated levels of ALAS1 messenger RNA (mRNA), leading to reduction of toxins associated with attacks and other disease manifestations of AHP. For more information about GIVLAARI, including the full U.S. Prescribing Information, visit GIVLAARI.com.

About OXLUMO (lumasiran)
OXLUMO (lumasiran) is an RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1). HAO1 encodes glycolate oxidase (GO). Thus, by silencing HAO1 and depleting the GO enzyme, OXLUMO inhibits production of oxalate – the metabolite that directly contributes to the pathophysiology of PH1. OXLUMO utilizes Alnylam’s Enhanced Stabilization Chemistry (ESC)-GalNAc-conjugate technology, which enables subcutaneous dosing with increased potency and durability and a wide therapeutic index. OXLUMO has received regulatory approvals from the U.S. Food and Drug Administration (FDA) for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients and from the European Medicines Agency (EMA) for the treatment of PH1 in all age groups. In the pivotal ILLUMINATE-A study, OXLUMO was shown to significantly reduce levels of urinary oxalate relative to placebo, with the majority of patients reaching normal or near-normal levels. In the ILLUMINATE-B pediatric Phase 3 study, OXLUMO demonstrated an efficacy and safety profile consistent to that observed in ILLUMINATE-A. In the ILLUMINATE-C study, OXLUMO resulted in substantial reductions in plasma oxalate in patients with advanced PH1. Across all three studies, injection site reactions (ISRs) were the most common drug-related adverse reaction. OXLUMO is administered via subcutaneous injection once monthly for three months, then once quarterly beginning one month after the last loading dose at a dose based on actual body weight. For patients who weigh less than 10 kg, ongoing dosing remains monthly. OXLUMO should be administered by a healthcare professional. For more information about OXLUMO, including the full U.S. Prescribing Information, visit OXLUMO.com.

About AMVUTTRA (vutrisiran)
AMVUTTRA (vutrisiran) is an RNAi therapeutic approved in the United States for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. It is a double‑stranded small interfering RNA (siRNA) that targets mutant and wild‑type transthyretin (TTR) messenger RNA (mRNA). Using Alnylam’s Enhanced Stabilization Chemistry (ESC)-GalNAc-conjugate delivery platform, AMVUTTRA is designed for increased potency and high metabolic stability to allow for subcutaneous injection once every three months (quarterly). Results from the pivotal HELIOS-A Phase 3 study demonstrate AMVUTTRA rapidly reduces serum TTR levels, has the potential to reverse neuropathy impairment relative to baseline and improves other key measures of disease burden relative to external placebo in patients with the polyneuropathy of hATTR amyloidosis. For more information about AMVUTTRA, including the full U.S. Prescribing Information, visit AMVUTTRA.com.

About LNP Technology
Alnylam has licenses to Arbutus Biopharma LNP intellectual property for use in RNAi therapeutic products using LNP technology.

About RNAi
RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as "a major scientific breakthrough that happens once every decade or so," and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines known as RNAi therapeutics is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, function upstream of today’s medicines by potently silencing messenger RNA (mRNA) – the genetic precursors – that encode for disease-causing or disease pathway proteins, thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.

On October 27, 2022 Alkermes plc (Nasdaq: ALKS) reported the 2022 recipients of the Alkermes Inspiration Grants program. Grants were awarded to nine nonprofit organizations working to address the needs of people living with alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and cancer (Press release, Alkermes, OCT 27, 2022, View Source [SID1234622450]). The selected programs also have a focus on addressing unmet needs in historically under-resourced or underrepresented communities with longstanding and widespread health disparities.

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"This year’s Alkermes Inspiration Grants recipients inspire us with their innovative approaches to providing critical support for people living with addiction, serious mental illness or cancer, as well as their caregivers and family members. These organizations have the potential to positively impact people across the U.S. and offer an opportunity to engage diverse communities in new ways," said Richard Pops, Chief Executive Officer of Alkermes.

Nearly 250 applications were submitted for this highly competitive program. Submissions were evaluated based on a set of criteria outlined in the request for proposals, including clearly defined needs, objectives, activity format, mode of delivery and intended audience, and relevance to historically under-resourced or underrepresented communities. Grant recipients were selected by a committee that included senior leaders from Alkermes and individuals from outside the organization chosen to represent the perspectives of people with lived experience, caregivers and patient advocates.

"Alkermes’ desire to support high-impact programs that can help those affected by addiction, cancer and serious mental illness came through clearly throughout the review process. I was impressed with the purposeful and collaborative effort, and the particular focus on supporting underserved communities and regions across the country," commented committee member Sharon Slade, Chief Marketing Officer, Cancer Research Institute.

Since 2016, the Alkermes Inspiration Grants program has awarded more than $4.5 million in funding to innovative programs that support the needs of those impacted by serious diseases in our areas of focus. For more information on the Alkermes Inspiration Grants program, please visit View Source

2022 Grant Recipient Organizations and Programs:

The American Psychiatric Association Foundation’s Building Bridges to Care: APAF Mental Health and Faith Community Partnership aims to foster dialogue to improve the understanding of mental health and substance use disorders, reduce stigma and increase connections to care with local community organizations, including faith-based organizations. The group will develop and disseminate culturally appropriate mental health information and resources for people with mental health and substance use disorders, including schizophrenia and bipolar disorder and/or caregivers for people living with these illnesses.

Community Anti-Drug Coalitions of America (CADCA) will create an alcohol use disorder (AUD) awareness video and fact sheet to further support CADCA’s training of local grassroots groups, known as community coalitions, with the goal of developing effective community problem-solving strategies related to substance use disorders. Groups are taught how to assess their local alcohol, tobacco and other drug-related problems and develop a comprehensive plan to address them. The video and fact sheet will be used to increase awareness and reduce stigma of AUD and seeking treatment.

Depression and Bipolar Support Alliance’s (DBSA) Addressing Mental Health Disparities Through Peer Support program will train Asian American/Pacific Islander, Black and rural peers with lived experience as support group facilitators and create 10 peer-led support groups. The goal is for participants to address and overcome systemic barriers, increase their access to mental health support and achieve positive mental health outcomes along their recovery journeys.

Foundation for Women’s Cancer’s (FWC) Move The Message campaign is designed to motivate high-risk and historically marginalized communities to take preventive action by increasing awareness of gynecologic cancers through dissemination of vital FWC resources. Gynecological cancer mortality rates are increasing among women of color and rural women, with late-stage diagnoses more prevalent due to lack of education and awareness. FWC will take its message directly to communities across the country to drive awareness and enhance education and support of early diagnoses by motivating people to help #MoveTheMessage.

The National Association for Children of Addiction’s (NACoA) Children Deserve Recovery, Too! program seeks to deliver NACoA’s Children Program Kit training on-demand via a Learning Management System to 40 community-based youth-serving nonprofits in historically under-resourced and underrepresented communities with high rates of alcohol or opioid use disorder. Children living with a parent or caregiver who has alcohol or opioid use disorder are at high risk for experiencing adverse childhood experiences (ACEs), making them vulnerable to lifelong negative mental and physical health consequences. Early prevention and intervention are key for addressing this systemic issue, and this program will provide proven, trauma-sensitive, culturally informed educational support programs to mitigate the impact of ACEs.

Ovarcome’s Lifecycle of OVARCOMING program seeks to eradicate disparities in equity of care and information to Ovarcomers that are in an underrepresented part of the population. Ovarcome will educate, inform, engage and empower ovarian cancer survivors, caregivers, friends, family members and the general population with information on screening, genetics, detection, diagnosis, and treatment; a book of inspiration with real life stories for newly diagnosed patients; a video and resource packet to make Ovarcomers feel cared for; and a Clinical Trials Finder in both English and Spanish, among other resources. This information will help people take ownership of their treatment process and the journey of OVARCOMING.

Parents of Addicted Loved Ones’ Healing Families of Substance Use Disorder in the Nation’s Largest Cities program will start free weekly meeting groups utilizing Parents of Addicted Loved Ones’ evidence-based education in the nation’s 15 largest cities. The lessons used in the meetings will give parents whose adult children suffer from substance use disorder (SUD) the tools needed to encourage their loved one’s recovery and provide peer-to-peer support to face the challenges of SUD.

Sound Mind Live’s "Released" Mental Health Docuseries on bipolar disorder will be a five-part docuseries that will take us inside the lives and work of five influential musicians living with bipolar disorder. Each episode will focus on one artist living with bipolar disorder and how their journey with the condition and making music helped them break free from stigma to find support, healing and, ultimately, themselves to share their creations with the world. This will further the work Sound Mind Live does to bring together a coalition of mental health and music organizations with musicians and music lovers to build a supportive community and open dialogue around mental illness.

Young People in Recovery’s (YPR) Native American Youth Substance Use Disorder Recovery Support Services Pilot will be a community-based chapter and redesign of one of their existing life-skills curriculum programs to be linguistically and culturally appropriate for Native American youths who struggle with substance misuse or who are in recovery from substance use disorder. YPR will partner with one tribe to launch a new chapter to serve tribal constituents under age 30. The program will be staffed by Native Americans and create a youth advisory board to inform the program with the values, language, and traditions of the specific tribe.

On October 27, 2022 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported a detailed, long-term business plan to drive shareholder value and also provided long-term financial guidance (Press release, Acorda Therapeutics, OCT 27, 2022, View Source [SID1234622449]).

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Acorda has developed a long-term business plan to increase the value of the Company, focused on growing INBRIJA (levodopa inhalation powder), maximizing AMPYRA (dalfampridine), and implementing additional operational and manufacturing efficiencies. Due to the recent Alkermes arbitration award, along with continued fiscal discipline, Acorda has substantial liquidity, which the Company expects will allow it to execute on its business plan. Acorda expects to be cash-flow positive in 2023. The outcome of the reverse stock split proposal at the upcoming Special Meeting of Stockholders, scheduled for November 4, 2022, will be a key determinant of Acorda’s strategic alternatives and ability to execute its business plan.

Key Assumptions Underlying Business Plan and Guidance

INBRIJA will continue to grow in the U.S.
INBRIJA will expand into additional ex-U.S. markets
AMPYRA will continue to lose market share, but at a stabilizing rate
Acorda’s expectation is to be cash-flow positive in 2023
Shareholder approval of reverse stock split proposal; continued Nasdaq listing
INBRIJA

The Company believes that INBRIJA has a significant opportunity to expand the market for on-demand treatments
INBRIJA currently enjoys a 67% market share within the on-demand treatment class1
Healthcare professionals report they are generally more comfortable with INBRIJA than apomorphine-based on-demand treatments2
< 2% of the 380,000 people with Parkinson’s who experience OFF periods are actively on any on-demand treatment3
Acorda is implementing high-potential initiatives to grow the INBRIJA business
Launching new brand campaigns for physicians and people with Parkinson’s
Expanding usage of recently launched E-prescribing platform, which removes barriers to prescribing and has increased fulfillment rates
Introducing cash-pay option to improve patient access
Focusing sales team with a hyper-targeted call strategy
Ex-U.S. revenue expected to increase in 2023 and 2024 as Germany launch progresses and additional launches commence in Spain and Latin America
Partner discussions are in progress for Asia and additional EU markets
AMPYRA

Alkermes arbitration ruling significantly improves operating margins
$16.5M cash received October 2022
No further royalty payments and ability to find lower-cost supply, which has already been secured
$10-$12M savings in 2023 annual cost of goods (based on volume)
AMPYRA net sales currently at ~13% of peak sales
AMPYRA currently holds ~15% of dalfampridine market4
Long-term value of the brand expected at ~10% of peak sales through 2027
Field team continues to promote the brand
~200 health care professionals resumed prescribing AMPYRA in 2022
Tenacity of prescribers and patients has resulted in fewer payer restrictions5
~70% of all covered lives have access to AMPYRA6
Financial Guidance

Acorda provided the following long-term financial guidance ranges, assuming successful implementation of the business plan and its key assumptions:

CEO Video Q&A Friday, October 28 at 1:00pm ET / 10:00am PT

Acorda will hold a video Q&A with its CEO, Ron Cohen, M.D., on Friday, October 28 at 1:00pm ET / 10:00am PT. The call will review Acorda’s long-term business plan and the items on the ballot for Acorda’s Special Meeting of Shareholders on November 4, 2022. Participants will be able to submit questions to Dr. Cohen, which he will address live.

Video Q&A Participation Instructions

To participate in the video event:

Click the link below from a laptop or mobile device. (Mobile device users will be prompted to download the BlueJeans app.) View Source
If prompted, enter the following case-sensitive Event ID: rraraavy

On October 26, 2022 Boston Scientific reported that it generated net sales of $3.170 billion during the third quarter of 2022, growing 8.1 percent on a reported basis, 13.7 percent on an operational1 basis and 11.5 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, OCT 26, 2022, View Source;_gl=1*lnrr96*_ga*MTE5OTI0MTk5Mi4xNjcyNDYzODY2*_ga_759NN7RMMK*MTY3MjQ2Mzg2NS4xLjEuMTY3MjQ2NDEwNS4wLjAuMA.. [SID1234625690]). The company reported GAAP net income available to common stockholders of $174 million or $0.12 per share (EPS), compared to $405 million or $0.28 per share a year ago, and achieved adjusted3 EPS of $0.43 for the period, compared to $0.41 a year ago.

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"I’m pleased with our team’s ongoing commitment to executing our strategy, and the double-digit organic revenue growth we delivered across nearly every business," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "Despite ongoing challenges in the macro environment, we remain focused on enhancing our portfolio and delivering strong global performance."

Third quarter financial results and recent developments:

Reported net sales of $3.170 billion, representing an increase of 8.1 percent on a reported basis, compared to the company’s guidance range of 6 to 8 percent; 13.7 percent on an operational basis; and 11.5 percent on an organic basis, compared to the company’s guidance range of 8 to 10 percent, all compared to the prior year period.
Reported GAAP net income available to common stockholders of $0.12 per share, compared to the company’s guidance range of $0.20 to $0.24 per share, and achieved adjusted EPS of $0.43 per share, compared to the guidance range of $0.43 to $0.45 per share.
Achieved net sales growth in each reportable segment4, compared to the prior year period:
MedSurg: 6.5 percent reported, 11.0 percent operational and 9.8 percent organic
Cardiovascular: 9.1 percent reported, 15.3 percent operational and 12.6 percent organic
Achieved net sales growth/(declines) in each region, compared to the prior year period:
U.S.: 12.0 percent reported and operational
EMEA (Europe, Middle East and Africa): (0.8) percent reported and 15.2 percent operational
APAC (Asia-Pacific): 2.8 percent reported and 15.3 percent operational
LACA (Latin America and Canada): 20.4 percent reported and 24.2 percent operational
Emerging Markets5: 28.1 percent reported and 40.0 percent operational
Received CE Mark for the LUX-Dx Insertable Cardiac Monitor System, a long-term diagnostic device inserted under the skin in patients to detect arrhythmias associated with conditions such as atrial fibrillation (AF), cryptogenic stroke and syncope.
Received U.S. Food and Drug Administration (FDA) approval to expand the instructions for use labeling for the WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device to include a 45-day dual anti-platelet therapy (DAPT) option as an alternative to 45-day oral anticoagulation plus aspirin for post-procedural treatment of patients with non-valvular atrial fibrillation.
Launched Rezūm Water Vapor Therapy, a non-surgical treatment for benign prostatic hyperplasia (BPH), in Japan following regulatory approval from Japan’s Ministry of Health, Labor and Welfare (MHLW) and approval of a new reimbursement category from Japan’s Central Social Insurance Medical Counsel (Chuikyo) for both the device and procedure.
Launched a line extension of the ELUVIA Drug-Eluting Stent (DES), introducing the longest-length DES (150 mm) available for treatment of patients with peripheral artery disease (PAD) in the superficial femoral artery (SFA).
Presented late-breaking clinical data for the PROTECTED TAVR randomized trial evaluating the use of the SENTINEL Cerebral Protection System to reduce the risk of peri-procedural stroke in patients with aortic valve stenosis who are indicated for transcatheter aortic valve replacement (TAVR). The primary endpoint was not met, as data demonstrated a non-significant 21% relative risk reduction in all-stroke through 72 hours or time of hospital discharge in patients treated with the device vs. TAVR alone, while a secondary non-powered analysis demonstrated a significant 63% relative risk reduction in disabling stroke.
Completed enrollment in the AGENT IDE trial, a prospective, multi-center, randomized study evaluating the safety and effectiveness of the AGENT Drug Coated Balloon for the treatment of patients with coronary artery disease who experience in-stent restenosis.
Completed the acquisition of Obsidio, Inc., a privately-held company that developed a gel embolic material technology used for embolization of blood vessels in the peripheral vasculature.

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 third quarter by business and region:

Increase/(Decrease)

Three Months Ended

September 30,

Reported
Basis

Less: Impact
of Foreign
Currency
Fluctuations

Operational

Basis

Less:

Impact of
Recent
Acquisitions
/ Divestitures

Organic
Basis

(in millions)

2022

2021

Endoscopy

$ 559

$ 533

4.9 %

(5.6) %

10.4 %

— %

10.4 %

Urology and Pelvic Health

433

384

12.6 %

(3.6) %

16.2 %

3.6 %

12.6 %

Neuromodulation

221

221

(0.1) %

(3.2) %

3.2 %

— %

3.2 %

MedSurg4

1,213

1,138

6.5 %

(4.4) %

11.0 %

1.2 %

9.8 %

Cardiology

1,479

1,342

10.2 %

(6.3) %

16.5 %

3.7 %

12.8 %

Peripheral Interventions

479

452

5.9 %

(6.0) %

12.0 %

— %

12.0 %

Cardiovascular4

1,958

1,794

9.1 %

(6.2) %

15.3 %

2.8 %

12.6 %

Net Sales

$ 3,170

$ 2,932

8.1 %

(5.5) %

13.7 %

2.2 %

11.5 %

Increase/(Decrease)

Three Months Ended
September 30,

Reported
Basis

Less: Impact
of Foreign
Currency
Fluctuations

Operational

Basis

(in millions)

2022

2021

U.S.

$ 1,934

$ 1,726

12.0 %

— %

12.0 %

EMEA

585

590

(0.8) %

(16.0) %

15.2 %

APAC

532

517

2.8 %

(12.5) %

15.3 %

LACA

119

99

20.4 %

(3.8) %

24.2 %

Net Sales

$ 3,170

$ 2,932

8.1 %

(5.5) %

13.7 %

Emerging Markets5

$ 454

$ 354

28.1 %

(11.9) %

40.0 %

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 Fourth Quarter 2022

The company now estimates net sales growth for the full year 2022, versus the prior year period, to be approximately 6.5 percent on a reported basis, and approximately 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 $0.57 to $0.63 and estimates adjusted EPS, excluding certain charges (credits), of $1.71 to $1.74.

The company estimates net sales growth for the fourth quarter of 2022, versus the prior year period, to be in a range of approximately 2 to 4 percent on a reported basis, and approximately 7 to 9 percent on an organic basis. Fourth 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 $0.23 to $0.28 and adjusted EPS, excluding certain charges (credits), of $0.45 to $0.48.

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 fourth quarter and full year 2022; our financial performance; our business plans and product performance, and new and anticipated product approvals and launches. 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

September 30,

Nine Months Ended

September 30,

in millions, except per share data

2022

2021

2022

2021

Net sales

$ 3,170

$ 2,932

$ 9,440

$ 8,761

Cost of products sold

979

900

2,945

2,739

Gross profit

2,191

2,032

6,495

6,022

Operating expenses:

Selling, general and administrative expenses

1,132

1,066

3,357

3,206

Research and development expenses

339

310

993

884

Royalty expense

11

14

34

38

Amortization expense

202

184

604

549

Intangible asset impairment charges

125

128

132

173

Contingent consideration net expense (benefit)

20

(26)

68

(117)

Restructuring net charges (credits)

4

9

18

18

Litigation-related net charges (credits)

—

—

42

302

Gain on disposal of businesses and assets

—

(40)

—

(48)

1,833

1,645

5,248

5,003

Operating income (loss)

358

387

1,247

1,019

Other income (expense):

Interest expense

(63)

(86)

(406)

(254)

Other, net

(51)

181

(96)

192

Income (loss) before income taxes

245

483

745

957

Income tax expense (benefit)

57

64

188

10

Net income (loss)

$ 188

$ 419

$ 558

$ 946

Preferred stock dividends

(14)

(14)

(42)

(42)

Net income (loss) available to common stockholders

$ 174

$ 405

$ 516

$ 905

Net income (loss) per common share – basic

$ 0.12

$ 0.28

$ 0.36

$ 0.64

Net income (loss) per common share – assuming
dilution

$ 0.12

$ 0.28

$ 0.36

$ 0.63

Weighted-average shares outstanding

Basic

1,431.6

1,423.8

1,429.7

1,421.3

Assuming dilution

1,440.0

1,435.6

1,438.7

1,433.0

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BOSTON SCIENTIFIC CORPORATION

NON-GAAP NET INCOME AND NET INCOME PER SHARE RECONCILIATIONS

(Unaudited)

Three Months Ended September 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

$ 2,191

$ 1,833

$ 358

$ (114)

$ 245

$ 188

$ (14)

$ 174

$ 0.12

Non-GAAP adjustments:

Amortization expense

—

(202)

202

—

202

174

—

174

0.12

Intangible asset impairment charges

—

(125)

125

—

125

96

—

96

0.07

Acquisition / divestiture-related net
charges (credits)

23

(65)

87

26

113

112

—

112

0.08

Restructuring and restructuring-related
net charges (credits)

14

(4)

18

—

18

16

—

16

0.01

Litigation-related net charges (credits)

—

—

—

—

—

(0)

—

(0)

(0.00)

Investment portfolio net losses (gains)

—

—

—

(3)

(3)

(3)

—

(3)

(0.00)

EU MDR implementation costs

12

(7)

20

—

20

17

—

17

0.01

Debt extinguishment charges

—

—

—

—

—

(0)

—

(0)

(0.00)

Deferred tax expenses (benefits)

—

—

—

—

—

35

—

35

0.02

Adjusted

$ 2,240

$ 1,430

$ 810

$ (91)

$ 719

$ 634

$ (14)

$ 620

$ 0.43

Three Months Ended September 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

$ 2,032

$ 1,645

$ 387

$ 95

$ 483

$ 419

$ (14)

$ 405

$ 0.28

Non-GAAP adjustments:

Amortization expense

—

(184)

184

—

184

168

—

168

0.12

Intangible asset impairment charges

—

(128)

128

—

128

109

—

109

0.08

Acquisition / divestiture-related net
charges (credits)

12

19

(7)

(225)

(232)

(230)

—

(230)

(0.16)

Restructuring and restructuring-related
net charges (credits)

19

(26)

44

—

44

39

—

39

0.03

Litigation-related net charges (credits)

—

—

—

—

—

(0)

—

(0)

(0.00)

Investment portfolio net losses (gains)

—

—

—

26

26

19

—

19

0.01

EU MDR implementation costs

9

(4)

13

—

13

12

—

12

0.01

Deferred tax expenses (benefits)

—

—

—

—

—

43

—

43

0.03

Discrete tax items

—

—

—

—

—

17

—

17

0.01

Adjusted

$ 2,071

$ 1,322

$ 750

$ (104)

$ 646

$ 595

$ (14)

$ 581

$ 0.41

(1) For the three months ended September 30, 2022 and 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)

Nine Months Ended September 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 (2)

Reported

$ 6,495

$ 5,248

$ 1,247

$ (502)

$ 745

$ 558

$ (42)

$ 516

$ 0.36

Non-GAAP adjustments:

Amortization expense

—

(604)

604

—

604

519

—

519

0.36

Intangible asset impairment charges

—

(132)

132

—

132

103

—

103

0.07

Acquisition / divestiture-related net
charges (credits)

73

(177)

250

26

276

279

—

279

0.19

Restructuring and restructuring-related
net charges (credits)

49

(33)

82

—

82

71

—

71

0.05

Litigation-related net charges (credits)

—

(42)

42

—

42

33

—

33

0.02

Investment portfolio net losses (gains)

—

—

—

8

8

4

—

4

0.00

EU MDR implementation costs

33

(19)

52

—

52

45

—

45

0.03

Debt extinguishment charges

—

—

—

194

194

149

—

149

0.10

Deferred tax expenses (benefits)

—

—

—

—

—

98

—

98

0.07

Discrete tax items

—

—

—

—

—

(0)

—

(0)

(0.00)

Adjusted

$ 6,651

$ 4,242

$ 2,409

$ (274)

$ 2,135

$ 1,858

$ (42)

$ 1,816

$ 1.26

Nine Months Ended September 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 (2)

Reported

$ 6,022

$ 5,003

$ 1,019

$ (62)

$ 957

$ 946

$ (42)

$ 905

$ 0.63

Non-GAAP adjustments:

Amortization expense

—

(549)

549

—

549

496

—

496

0.35

Intangible asset impairment charges

—

(173)

173

—

173

148

—

148

0.10

Acquisition / divestiture-related net
charges (credits)

33

52

(19)

(425)

(444)

(449)

—

(449)

(0.31)

Restructuring and restructuring-related
net charges (credits)

59

(74)

133

—

133

118

—

118

0.08

Litigation-related net charges (credits)

—

(302)

302

—

302

233

—

233

0.16

Investment portfolio net losses (gains)

—

—

—

178

178

136

—

136

0.09

EU MDR implementation costs

24

(12)

35

—

35

32

—

32

0.02

Deferred tax expenses (benefits)

—

—

—

—

—

86

—

86

0.06

Discrete tax items

—

—

—

—

—

(21)

—

(21)

(0.01)

Adjusted

$ 6,138

$ 3,946

$ 2,191

$ (308)

$ 1,883

$ 1,725

$ (42)

$ 1,683

$ 1.17

(2) For the nine months ended September 30, 2022 and 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
Q4 and FY 2022 GUIDANCE RECONCILIATIONS
(Unaudited)

Net Sales

Q4 2022 Estimate

Full Year 2022
Estimate

(Low)

(High)

Reported growth

2.0 %

4.0 %

~6.5%

Less: Impact of foreign currency fluctuations

(6.5) %

(6.5) %

~(5.0)%

Operational growth

8.5 %

10.5 %

~11.5%

Less: Impact of certain acquisitions / divestitures

1.5 %

1.5 %

~2.5%

Organic growth

7.0 %

9.0 %

~9.0%

Earnings per Share

Q4 2022 Estimate

Full Year 2022 Estimate

(Low)

(High)

(Low)

(High)

GAAP results

$ 0.23

$ 0.28

$ 0.57

$ 0.63

Amortization expense

0.12

0.12

0.48

0.48

Intangible asset impairment charges

—

—

0.07

0.07

Acquisition / divestiture-related net charges (credits)

0.04

0.03

0.23

0.22

Restructuring and restructuring-related net charges (credits)

0.03

0.02

0.08

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

$ 0.45

$ 0.48

$ 1.71

$ 1.74

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 charges (credits); 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), which 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); and certain litigation-related net charges (credits), EU MDR implementation costs, debt extinguishment charges, deferred tax expenses (benefits) and discrete tax items. 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.

On October 26, 2022 Papyrus Therapeutics Inc reported that Data will be presented by R Yang and colleagues from the Guangxi Medical University Cancer Hospital and H Gabra demonstrating that intravenously administered rOPCML-Fc has excellent tumor targeting affinity forhuman ovarian cancer patient derived xenografts (PDX) and produces strong dose dependent monotherapy efficacy both in-vitro and in-vivo (Press release, Papyrus Therapeutics, OCT 26, 2022, View Source;utm_medium=rss&utm_campaign=papyrus-therapeutics-research-presentation-at-the-34th-eortc-nci-aacr-meeting-in-barcelona-spain-on-27th-october%25ef%25bf%25bc [SID1234623197]). Intravenous treatment at 10mg/kg over 4 weeks showed a 93% reduction in tumor volume without any obvious toxicities as judged by lack of differences in animals’ activities and weight in treated animals, as compared with control vehicle treated animals.

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Chief Scientific Officer Professor Hani Gabra commented "We are excited to present these data which confirm that our approach to the intravenous restoration of tumor suppression function is indeed feasible, efficacious and safe using our recombinant engineered Fc fusion Opioid Binding/Cell Adhesion Molecule-like [rOPCML]. These encouraging results are consistent with data generated by Papyrus and support the company’s effort to develop novel extracellular tumor suppressor therapies."