Boston Scientific Announces Results for Second Quarter 2024

On July 24, 2024 Boston Scientific Corporation (NYSE: BSX) reported net sales of $4.120 billion during the second quarter of 2024, growing 14.5 percent on a reported basis, 16.1 percent on an operational1 basis and 14.7 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, JUL 24, 2024, View Source [SID1234645035]). The company reported GAAP net income attributable to Boston Scientific common stockholders of $324 million or $0.22 per share (EPS), compared to $261 million or $0.18 per share a year ago, and achieved adjusted3 EPS of $0.62 for the period, compared to $0.53 a year ago.

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"We delivered a quarter marked by exceptional performance, reflecting our global team’s relentless pursuit of innovation that is supported by strong clinical evidence and investments aligned with our strategy of category leadership," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "We remain excited about our plans for the future, and I am incredibly grateful for the commitment and winning spirit of our employees around the world."

Second quarter financial results and recent developments:

Reported net sales of $4.120 billion, representing an increase of 14.5 percent on a reported basis, compared to the company’s guidance range of 10.5 to 12.5 percent; 16.1 percent on an operational basis; and 14.7 percent on an organic basis, compared to the company’s guidance range of 10 to 12 percent, all compared to the prior year period.

Reported GAAP net income attributable to Boston Scientific common stockholders of $0.22 per share, compared to the company’s guidance range of $0.35 to $0.37 per share, and achieved adjusted EPS of $0.62 per share, compared to the guidance range of $0.57 to $0.59 per share.

Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 9.0 percent reported, 10.1 percent operational and 7.6 percent organic
Cardiovascular: 17.8 percent reported, 19.7 percent operational and 19.0 percent organic

Achieved the following net sales growth in each region, compared to the prior year period:
United States (U.S.): 16.9 percent reported and operational
Europe, Middle East and Africa (EMEA): 13.7 percent reported and 16.1 percent operational
Asia-Pacific (APAC): 7.0 percent reported and 13.2 percent operational
Latin America and Canada (LACA): 15.3 percent reported and 15.7 percent operational
Emerging Markets4: 14.8 percent reported and 19.3 percent operational

Received National Medical Products Administration (NMPA) approval in China for the FARAPULSE Pulsed Field Ablation (PFA) System.

Presented the following clinical data at Heart Rhythm 2024:
Outcomes from a sub-analysis of the pivotal ADVENT clinical trial of the FARAPULSE PFA System, which demonstrated that treatment with the system resulted in an atrial arrhythmia burden (i.e., the total arrhythmia duration experienced by a patient) of less than 0.1% – a clinically meaningful threshold – in significantly more patients compared to thermal ablation.
Acute outcomes from the global FARADISE registry, which demonstrated favorable 30-day outcomes in more than 1,100 patients treated with the FARAPULSE PFA System, with no deaths or reports of coronary spasm, persistent phrenic nerve palsy, atrioesophageal fistula or pulmonary vein stenosis.
Positive results from the ongoing pivotal MODULAR ATP clinical trial of the Modular CRM (mCRM) System5 which met all pre-specified six-month safety and effectiveness endpoints. This is the first modular cardiac rhythm management (mCRM) system that consists of the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) System and the EMPOWER Leadless Pacemaker.

Initiated the U.S. launch of the AGENT Drug-Coated Balloon, indicated to treat in-stent restenosis in patients with coronary artery disease, and received NMPA approval for the device in China.

Announced agreement to acquire Silk Road Medical, Inc., (Nasdaq: SILK) a publicly traded medical technology company that commercialized a platform of products to prevent stroke in patients with carotid artery disease, subject to customary closing conditions.

Presented outcomes at the 2024 American Society of Pain & Neuroscience meeting from three follow-up studies of patients treated with the Intracept Intraosseous Nerve Ablation System, which demonstrated significant improvements in vertebrogenic pain with nearly one-third of patients 100% pain free after five years.

Elected to the company’s board of directors Dr. Cheryl Pegus, former partner at Morgan Health and former executive vice president of Health & Wellness at Walmart.

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 other intangible asset impairment charges, acquisition/divestiture-related net charges (credits), investment portfolio net losses (gains) and impairments, restructuring and restructuring-related net charges (credits), certain litigation-related net charges (credits), European Union Medical Device Regulation (EU MDR) implementation costs, debt extinguishment net charges, deferred tax expenses (benefits) and certain discrete tax items.
4. Periodically, we assess our list of Emerging Markets countries, and effective January 1, 2023, modified our list to include all countries except the United States, Western and Central Europe, Japan, Australia, New Zealand and Canada.
5. The EMPOWER Leadless Pacemaker is an investigational device and limited by U.S. law to investigational use only. It is not available for sale. Some device references are for informational purposes only and are pending CE Mark. Not available in the European Economic Area.

Net sales for the second quarter by business and region:

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Increase/(Decrease)

Three Months Ended

June 30,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational

Basis

Impact of
Recent
Acquisitions/
Divestitures

Organic
Basis

(in millions)

2024

2023

Endoscopy

$ 676

$ 631

7.1 %

1.3 %

8.4 %

(0.5) %

7.9 %

Urology

525

485

8.2 %

0.9 %

9.1 %

— %

9.1 %

Neuromodulation

282

244

15.5 %

0.7 %

16.2 %

(12.5) %

3.7 %

MedSurg

1,483

1,360

9.0 %

1.0 %

10.1 %

(2.5) %

7.6 %

Cardiology

2,047

1,704

20.1 %

1.9 %

22.0 %

— %

22.0 %

Peripheral Interventions

590

535

10.2 %

2.1 %

12.3 %

(2.8) %

9.4 %

Cardiovascular

2,637

2,239

17.8 %

1.9 %

19.7 %

(0.7) %

19.0 %

Net Sales

$ 4,120

$ 3,599

14.5 %

1.6 %

16.1 %

(1.4) %

14.7 %

View News Release Full Screen

Increase/(Decrease)

Three Months Ended June 30,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational

Basis

(in millions)

2024

2023

U.S.

$ 2,466

$ 2,110

16.9 %

— %

16.9 %

EMEA

822

723

13.7 %

2.5 %

16.1 %

APAC

670

626

7.0 %

6.2 %

13.2 %

LACA

162

140

15.3 %

0.4 %

15.7 %

Net Sales

$ 4,120

$ 3,599

14.5 %

1.6 %

16.1 %

Emerging Markets4

$ 680

$ 592

14.8 %

4.6 %

19.3 %

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

Net sales 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 2024

The company estimates net sales growth for the full year 2024, versus the prior year period, to be in range of approximately 13.5 to 14.5 percent on a reported basis, and 13 to 14 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 estimates EPS on a GAAP basis in a range of $1.34 to $1.38 and estimates adjusted EPS, excluding certain charges (credits), of $2.38 to $2.42.

The company estimates net sales growth for the third quarter of 2024, versus the prior year period, to be in a range of approximately 13 to 15 percent on both a reported basis and 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 $0.36 to $0.38 and adjusted EPS, excluding certain charges (credits), of $0.57 to $0.59.

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: investors.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.

Alkermes plc Reports Second Quarter 2024 Financial Results

On July 24, 2024 Alkermes plc (Nasdaq: ALKS) reported financial results for the second quarter of 2024 (Press release, Alkermes, JUL 24, 2024, View Source [SID1234645034]).

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"Our second quarter results reflect solid execution across our business, delivering double-digit, year-over-year growth for our proprietary commercial product portfolio and robust profitability. We enter the second half of the year in a strong financial position with clear operational priorities to drive the performance of our commercial portfolio and advance our neuroscience development pipeline, including the phase 2 program for ALKS 2680 in narcolepsy type 1 and type 2," said Richard Pops, Chief Executive Officer of Alkermes. "As a profitable, smid-cap biotech growth company with multiple commercial products and a development pipeline with significant value potential, we are executing our plan to become a leader in the field of neuroscience."

Key Financial Highlights

Revenues

(In millions)

Three Months Ended
June 30,

Six Months Ended
June 30,

2024

2023

2024

2023

Total Revenues

$

399.1

$

617.4*

$

749.5

$

905.0*

Total Proprietary Net Sales

$

269.3

$

231.5

$

502.8

$

446.2

VIVITROL

$

111.9

$

102.1

$

209.5

$

198.7

ARISTADAi

$

86.0

$

82.4

$

164.9

$

162.5

LYBALVI

$

71.4

$

47.0

$

128.4

$

85.0

Profitability

(In millions)

Three Months Ended
June 30,

Six Months Ended
June 30,

2024

2023

2024

2023

GAAP Net Income From Continuing Operations

$

94.7

$

279.1

$

133.6

$

267.1

GAAP Net Loss From Discontinued Operations

$

(3.3)

$

(42.0)

$

(5.4)

$

(71.8)

GAAP Net Income

$

91.4

$

237.1*

$

128.2

$

195.2*

Non-GAAP Net Income From Continuing Operations

$

123.4

$

134.3

$

199.6

$

164.4

Non-GAAP Net Loss From Discontinued Operations

$

(3.3)

$

(40.0)

$

(5.4)

$

(67.7)

Non-GAAP Net Income

$

120.1

$

94.3

$

194.2

$

96.7

EBITDA From Continuing Operations

$

118.6

$

299.1

$

170.1

$

306.2

EBITDA From Discontinued Operations

$

(3.9)

$

(41.4)

$

(6.4)

$

(77.4)

EBITDA

$

114.7

$

257.7*

$

163.7

$

228.9*

*As a result of the successful resolution of the arbitration with Janssen Pharmaceutica N.V., the three months ended June 30, 2023 included approximately $245.5 million of back royalties (and related interest) related to U.S. net sales of long-acting INVEGA products (consisting of $195.4 million for 2022 and $50.1 million for the first quarter of 2023) that would ordinarily have been recognized in prior periods.

Revenue Highlights

LYBALVI

Revenues for the quarter were $71.4 million.
Revenues and total prescriptions for the quarter grew 52% and 44%, respectively, compared to the second quarter of 2023.
ARISTADAi

Revenues for the quarter were $86.0 million.
New to brand prescriptions for the quarter grew 6% sequentially compared to the first quarter of 2024.
VIVITROL

Revenues for the quarter were $111.9 million.
Revenues for the quarter grew 10% compared to the second quarter of 2023, driven by the alcohol dependence indication.
Manufacturing & Royalty Revenues

Royalty revenues from INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI for the quarter were $78.7 million.
VUMERITY manufacturing and royalty revenues for the quarter were $35.2 million.
Key Operating Expenses

Please see Note 1 below for details regarding discontinued operations.

(In millions)

Three Months Ended
June 30,

Six Months Ended
June 30,

2024

2023

2024

2023

R&D Expense – Continuing Operations

$

59.6

$

68.2

$

127.3

$

132.0

R&D Expense – Discontinued Operations

$

3.9

$

32.6

$

6.4

$

62.4

SG&A Expense – Continuing Operations

$

168.1

$

195.8

$

347.9

$

363.6

SG&A Expense – Discontinued Operations

$

$

9.5

$

$

16.1

Balance Sheet

At June 30, 2024, the company recorded cash, cash equivalents and total investments of $962.5 million, compared to $807.8 million at March 31, 2024. The company’s total debt outstanding as of June 30, 2024 was $289.5 million.

Share Repurchase Program
During the second quarter of 2024, the company repurchased approximately 3.5 million of the company’s ordinary shares under the share repurchase program authorized in February 2024, at a total purchase price of $84.7 million. As of June 30, 2024, the company had $315.3 million (exclusive of any fees, commissions or other expenses related to such repurchases) remaining under the program.

Financial Expectations for 2024
Alkermes reiterates its financial expectations for 2024, as set forth in its press release dated Feb. 15, 2024.

Recent Events

In April 2024, the company announced positive topline results from the narcolepsy type 2 and idiopathic hypersomnia cohorts in its phase 1b proof-of-concept study evaluating ALKS 2680, the company’s novel, investigational, oral orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy.
In April 2024, the company announced initiation of its Vibrance-1 phase 2 study of ALKS 2680 in patients with narcolepsy type 1.
In May 2024, the company completed the sale of its development and manufacturing facility in Athlone, Ireland to Novo Nordisk. Alkermes received a cash payment for the facility and certain related assets of approximately $91 million.
In May and June 2024, the company presented research related to its psychiatry franchise products—LYBALVI (olanzapine and samidorphan) and ARISTADA (aripiprazole lauroxil)—at several scientific conferences. The conferences included: American Psychiatric Association (APA) Annual Meeting, American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, and Psych Congress Elevate.
In June 2024, the company presented new research related to ALKS 2680 and narcolepsy, including new data from the full narcolepsy type 1 cohort in its phase 1b, proof-of-concept study evaluating ALKS 2680, at SLEEP 2024, the 38th annual meeting of the Associated Professional Sleep Societies (APSS).
Notes and Explanations

1. The company determined that upon the separation of its oncology business, completed on Nov. 15, 2023, the oncology business met the criteria for discontinued operations in accordance with Financial Accounting Standards Board Accounting Standards Codification 205, Discontinued Operations. Accordingly, the accompanying selected financial information has been updated to present the results of the oncology business as discontinued operations for the three and six months ended June 30, 2023.

Conference Call
Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, July 24, 2024, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes’ website.

AIM Announces New Positive Data on Ampligen’s Anti-Tumor Potential When Used as Part of a Combination Therapy

On July 24, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported the publication of new pre-clinical data concerning the company’s drug Ampligen as part of a combinational therapy in the treatment of melanoma, showing that combination dendritic cell-based vaccines including anti-PD-L1 checkpoint inhibitors and Ampligen-containing chemokine modulation helped slow tumor cell growth and improved survival in a mouse model (Press release, AIM ImmunoTech, JUL 24, 2024, View Source [SID1234645033]).

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"Therapeutic Anti-Tumor Efficacy of DC-Based Vaccines Targeting TME-Associated Antigens is Improved When Combined with a Chemokine-Modulating Regimen and/or Anti-PD-L1" was published in the peer-reviewed journal Vaccines.

AIM Medical Officer David Strayer, MD, stated: "This new pre-clinical data further demonstrates Ampligen’s therapeutic potential when used with dendritic-cell vaccines, with anti-PD-L1 checkpoint inhibitors, or in combination with both. The data supports AIM’s belief that we are on the right path in our ongoing development of Ampligen as an anti-tumor therapy."

ICE Bioscience Secures B++ Round Funding to Fuel Global Expansion and Innovation in Drug Discovery

On July 23, 2024 ICE Bioscience reported that the company has successfully closed its B++ round of financing (Press release, ICE Bioscience, JUL 23, 2024, View Source;catname=icenews [SID1234647428]). This achievement marks another substantial endorsement from the capital markets, following our significant fundraising effort in August 2023.

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As a high-growth CRO, this new funding will enable us to expand our cutting-edge services to the global pharmaceutical industry, enhancing our ability to support our clients in drug discovery and development.

We are grateful for the trust and commitment from our financial partners as we continue to innovate and grow. Stay tuned for more updates as we further our mission to drive progress and support the pharmaceutical sector.

Orange Grove Bio and University of Chicago Form Strategic Partnership to Accelerate Biotech Innovation and Commercialization

On July 23, 2024 Orange Grove Bio, a leading integrated biopharmaceutical company, and the University of Chicago’s Polsky Center for Entrepreneurship and Innovation reported a strategic partnership to catalyze the successful commercialization of novel therapeutics and life sciences technologies (Press release, Orange Grove Bio, JUL 23, 2024, View Source [SID1234645078]).

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This collaboration will combine Orange Grove Bio’s expertise in evaluating and financing novel therapeutics with the University of Chicago’s cutting-edge research capabilities. Orange Grove Bio plans to license promising life sciences technologies from the University of Chicago, developing them into new products to enhance human health. The company will provide its scientific expertise and business acumen to support early company formation.

"The University of Chicago boasts superior academic prowess and researchers who are at the top of their field," said Rich Ganz, Senior Venture Partner at Orange Grove Bio. "Our shared resources will maximize the chances of moving groundbreaking work from the lab to the clinic with the goal of benefiting patients in need."

The partnership encompasses several key aspects designed to foster innovation and collaboration. This includes new educational opportunities, such as workshops, seminars, networking events, and mentoring. Additionally, Orange Grove Bio will lead a PhD internship program, offering students valuable career exploration opportunities.

"This partnership will give the team at Orange Grove Bio an inside look at the novel work being done at the University of Chicago and provide our researchers with opportunities to gain industry-informed perspectives on their innovations," said Samir Mayekar, managing director of The University of Chicago’s Polsky Center. "We share a commitment to advancing scientific discoveries and strengthening the biotech ecosystem in Chicago, particularly on the South Side."

This strategic partnership represents a significant step forward in bridging regional gaps in venture capital funding and accelerating the translation of scientific breakthroughs into life-changing treatments. To further these goals, Orange Grove Bio plans to establish a presence on the South Side of Chicago, enabling close interaction with the academic teams at the University and amplifying its commitment to the Midwest biotech ecosystem.

"This partnership is a valuable addition to the University’s resources," said Jeffrey Hubbell, Professor at the University of Chicago’s Pritzker School of Molecular Engineering and founder of several life science companies. "The detailed feedback the Orange Grove Bio team is able to provide helps inform what additional studies or data we should pursue to empower successful external financing."