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.

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."

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.

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."

On July 23, 2024 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported positive treatment updates from its Phase 2 clinical trial, THIO-101, evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo) in patients with advanced non-small cell lung cancer (NSCLC) who failed two or more standard-of-care therapy regimens (Press release, MAIA Biotechnology, JUL 23, 2024, View Source [SID1234645029]).

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The trial’s therapeutic regimen is cycled every 3 weeks, with THIO 180mg administered in 60mg incremental doses on days 1, 2 and 3, followed by immune activation on day 4 (no dosing), and cemiplimab 350mg administered on day 5. As of the latest clinical cutoff date, June 12, 2024:

6 patients remain on treatment following at least 12 months of therapy.
Treatment with THIO followed by cemiplimab has been well tolerated throughout the trial, with much lower toxicity compared to standard-of care treatments.
Continuing treatment past 12 months demonstrates safety, efficacy and ongoing benefit from MAIA’s novel telomere targeting NSCLC therapy.
"Our longest treated patient so far has completed 21 cycles of THIO sequenced with a CPI, and 6 patients who have crossed the 12-month survival follow-up are continuing the treatment," said Vlad Vitoc, M.D., Chairman and Chief Executive Officer of MAIA. "With current therapies, second-line patients’ treatment duration is usually around 3-4 months1 and third-line is even lower than that. It is very encouraging to see that our patients can remain on treatment for much longer. The ongoing benefits of THIO in longer-term patients are particularly notable, signifying THIO’s potential as a durable and efficacious treatment for advanced NSCLC patients faced with limited options."

https://www.sciencedirect.com/science/article/pii/S0169500217304373

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with cemiplimab (Libtayo) followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.