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Lilly and Breast Cancer Advocacy Organizations Collaborate to Drive Awareness of the Complexities of Early Breast Cancer and the Risk of Recurrence

On February 16, 2022 Eli Lilly reported that Breast cancer is a complex disease with many factors that influence whether the cancer will return or spread, yet few resources exist to help people diagnosed with breast cancer understand these risk factors (Press release, Eli Lilly, FEB 16, 2022, View Source [SID1234608178]). In recognizing the need for more education about breast cancer recurrence, Eli Lilly and Company (NYSE: LLY) today launched a new education campaign in collaboration with Breastcancer.org, For the Breast of Us, Living Beyond Breast Cancer, and Susan G. Komen. This campaign aims to educate, support, connect, and empower people diagnosed with early breast cancer (EBC) that has a high risk of recurrence.

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More than 290,650 women and 2,710 men are expected to be diagnosed with breast cancer in the U.S. in 2022.1 Resources often describe early stage breast cancer as treatable and survivable. However, most people are at some risk of recurrence — and understanding individual risk factors is critical. This new initiative is focused on people diagnosed with the most common subtype of EBC: hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-).

"Too often, the risk of breast cancer coming back or progressing to metastatic disease is not part of the care team discussion as people navigate diagnosis, treatment, and care. We believe patients benefit from open conversations about breast cancer recurrence," said Jean Sachs, CEO, Living Beyond Breast Cancer (LBBC). "LBBC is proud to work alongside Breastcancer.org, For the Breast of Us, and Susan G. Komen to collaborate with Lilly in launching this educational campaign."

This initiative provides educational materials and other resources specifically developed for people with HR+, HER2- EBC and their care partners to better understand the complexity of the disease, including the risk of recurrence. The campaign features a digital fact sheet, patient conversation guide, and infographic, all of which explain the clinical characteristics associated with an increased risk of breast cancer recurrence and provide tools in planning treatment in partnership with a care team. Learn more about the campaign’s educational resources here.

"When people are diagnosed with early breast cancer, the initial focus is understandably on selecting and undergoing treatment that will prevent or delay cancer recurrence. However, the risk of developing recurrence may be difficult to comprehend and patients can benefit from additional resources to help understand or augment the information provided by their doctors," said Stacy Moulder, M.D., senior medical director of Lilly Oncology.

Dr. Moulder continued, "This initiative provides patients with comprehensive information on the factors that may affect the risk of breast cancer recurrence. Lilly’s collaboration with advocacy organizations, each of which play a vital role in the breast cancer community, will drive the conversation about risk of breast cancer recurrence further and enable patients to have more informed, proactive discussions with their doctors."

About Early Breast Cancer
Early breast cancer (EBC) is cancer that has not spread beyond the breast or underarm lymph nodes. The most common type of breast cancer is HR+, HER2-. Most EBC is treatable and does not return. However, there are many factors that may influence whether the breast cancer returns.

Fate Therapeutics to Webcast Conference Call Reporting Fourth Quarter and Full Year 2021 Financial Results

On February 16, 2022 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, reported that the Company will host a conference call and live audio webcast on Monday, February 28, 2022 at 5:00 PM ET to report its fourth quarter and full year 2021 financial results and provide a corporate update (Press release, Fate Therapeutics, FEB 16, 2022, https://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-webcast-conference-call-reporting-fourth-7 [SID1234608177]).

In order to participate in the conference call, please dial (877) 303-6235 (domestic) or (631) 291-4837 (international) and refer to conference ID 1888465. The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

Equillium Acquires Bioniz Therapeutics Significantly Expanding Pipeline of Novel Immunomodulatory Drug Candidates

On February 16, 2022 Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need, reported that it has acquired Bioniz Therapeutics, Inc., a privately held clinical-stage biotechnology company (Press release, Equillium, FEB 16, 2022, View Source [SID1234608176]). Bioniz developed its novel structured-domain peptides, including BNZ-1 and BNZ-2, entirely in-house from its proprietary product discovery platform. The Bioniz lead product candidates are multi-specific inhibitors of key disease-driving, clinically validated cytokine targets aimed at addressing unmet needs across a range of immuno-inflammatory indications.

Through the acquisition, Equillium significantly expands its immunology pipeline with a diversified portfolio of first-in-class immuno-inflammatory drug candidates across a range of development stages, consisting of:

BNZ-1: a first-in-class, tri-specific inhibitor of IL-2, IL-9 and IL-15, three inflammatory cytokines implicated in multiple diseases. BNZ-1 has demonstrated clinical proof-of-concept as a novel cytokine inhibitor through a completed Phase 1/2 study in cutaneous T cell lymphoma (CTCL), a dermato-oncology indication, achieving its primary objective of safety and tolerability where the compound was shown to be well tolerated with a favorable safety profile and showed clinically meaningful improvements in mSWAT scores (modified severity-weighted assessment tool). BNZ-1 is Phase 2 ready in alopecia areata, a dermatological autoimmune disorder, and is Phase 2/3 ready in CTCL with open U.S. INDs for each indication and has orphan designation for CTCL in the U.S. and Europe. BNZ-1 is currently formulated for intravenous administration, with subcutaneous formulation development underway. Equillium plans to initially focus further development of BNZ-1 in patients suffering from alopecia areata, where currently no drugs are approved.

BNZ-2: a first-in-class, selective inhibitor of IL-15 and IL-21. BNZ-2 has undergone substantial translational work supporting its potential use as a treatment for various gastrointestinal diseases and is Phase 1 ready for a study planned to include a proof-of-concept evaluation in patients with celiac disease, an immune disorder related to gluten exposure. The high degree of selectivity for IL-15 and IL-21 inhibition aligns well with the demonstrated key involvement of these two cytokines that work synergistically in driving the pathology in celiac disease and other inflammatory gut and hepatic disorders. BNZ-2 is currently formulated for subcutaneous administration where it is positioned to address an unmet need in patients experiencing symptoms despite attempts to maintain a gluten-free diet.

Discovery Platform: Proprietary and patented technology with origins from the National Institute of Health where seminal discoveries in cytokine biology were made. The flexible, structure-based platform is paired with deep in-house knowledge of cytokine pathways and computational modeling to create a discovery capability generating highly differentiated immunology products. The discovery pipeline includes BNZ-3, an advanced pre-clinical candidate that is a stabilized peptide designed to be orally administered and locally acting in the gut to treat GI inflammation.

This robust pipeline, combined with Equillium’s lead asset, itolizumab, a first-in-class anti-CD6 monoclonal antibody being advanced in a Phase 3 study in acute graft-versus-host disease (aGVHD), substantially expands Equillium’s breadth in immunology. This is consistent with our strategy to identify and secure novel drug candidates that are differentiated and synergistic with our expertise in immuno-inflammatory conditions.

"This acquisition is transformative for Equillium. Expanding our pipeline with multiple first-in-class immunomodulatory drug candidates targeting various cytokines sets the stage for significant future potential growth and value creation, including strategic partnering opportunities," said Bruce Steel, chief executive officer of Equillium. "The synergy of the Bioniz drug candidate portfolio with our current capabilities and expertise in immunology could not be stronger. Given today’s market conditions, we felt the time was right to be strategically opportunistic and we are pleased to add these exciting assets to our pipeline which we believe, in combination with itolizumab, can drive significant value for shareholders. Today, we are well positioned to bring novel therapies to patients living with severe immuno-inflammatory diseases and look forward to advancing these molecules into later stage development."

David Pyott, chairman of the board of Bioniz added: "We were most impressed with Equillium’s synergistic mission, deep expertise in immunology and inflammation and strong development capabilities that are uniquely positioned to carry Bioniz’s assets forward. We have every confidence in the Equillium team to drive these programs to success, and to fully realize the potential of our pipeline and novel product discovery platform."

"Our immune system is incredibly complex, with instances of redundancy or synergy seen across a number of key signaling pathways creating challenges for effective therapeutic intervention," said Stephen Connelly, Ph.D., chief scientific officer of Equillium. "The ability to selectively modulate more than one of these key pathways in a manner that addresses this complexity has significant advantages. We believe the Bioniz lead assets, acting upstream, can do this without the broad immuno-suppressive or off-target effects such as those experienced with JAK inhibitors as a class."

Alexandre Kaoukhov, M.D., joins Equillium as senior vice president of clinical development to oversee development of the Bioniz assets. Dr. Kaoukhov, a dermatologist with over twenty years’ experience in the biopharmaceutical industry, brings tremendous medical and development expertise to Equillium. Prior to Bioniz, he was head of global development at Almirall, head of medical dermatology at Allergan, principal medical scientific expert at Novartis, and clinical research physician at Galderma. In addition, Nazli Azimi, Ph.D., founder and CEO of Bioniz, will be retained as an advisor to Equillium while other key research and clinical personnel from Bioniz will transition to Equillium.

We are pleased to announce the promotion of Maple Fung, M.D., to senior vice president of clinical development to oversee itolizumab development. Dr. Fung, a board-certified nephrologist, joined Equillium in early 2020 and has been central to the strategy and clinical leadership of the itolizumab programs. Prior to Equillium, Dr. Fung held senior clinical development roles at Arena Pharmaceuticals, Ionis Pharmaceuticals, Ardea Biosciences, and Amgen.

Following the acquisition, Dolca Thomas, M.D., chief medical officer and executive vice president of research and development at Equillium, will be leaving the company. We would like to thank Dr. Thomas for her contributions to the company.

Transaction Details

With the acquisition of Bioniz, Equillium obtained exclusive worldwide rights to all current and future Bioniz products. The transaction consideration is comprised of an all-stock upfront payment of 5,699,492 unregistered shares of common stock of Equillium issuable to Bioniz stockholders, which represents approximately 19.3% of Equillium’s outstanding capital stock. Approximately 97% of the issued Equillium stock is subject to a standard 6-month lock-up provision and thereafter will be released ratably each month over the following 6 months. Equillium is also obligated to pay Bioniz stockholders up to $57.5 million in potential development milestone payments across three Bioniz clinical candidates (BNZ-1, BNZ-2, and BNZ-3) beginning upon first U.S. marketing approval, and up to $250 million in sales milestone payments based upon BNZ-1 achieving calendar year global net sales of $500, $1,000, $1,500, and $2,000 million. Other than the aforementioned milestones, Equillium does not have any third-party obligations with respect to milestones or royalties related to the Bioniz products or platform. Equillium has sole discretion over the timing and extent of advancing clinical development of the Bioniz products. Bioniz was estimated to have modestly positive net working capital at closing.

Webcast and Conference Call

Management will host a conference call accompanied by a slide presentation to discuss the acquisition of Bioniz for analysts and institutional investors, at 8:00 am ET today, February 16, 2022. To access the call, please dial (888) 350-3846 or (646) 960-0251 and, if needed, provide confirmation number 8770084. A live webcast of the call will also be available on the company’s Investor Relations page at View Source The webcast will be archived for 180 days.

About Itolizumab

Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.

Curve Therapeutics Announces Collaboration with MSD for Next Generation Drug Discovery Platform

On February 16, 2022 Curve Therapeutics (Curve), a private biotechnology company pioneering a potentially game-changing, functional drug discovery platform, reported a global research collaboration with MSD, the trade name of Merck & Co., Inc., Kenilworth, NJ USA, to discover and validate modulators of up to five therapeutic targets using its Microcycle technology, initially for oncology and neurology indications (Press release, Curve Therapeutics, FEB 16, 2022, View Source [SID1234608175]).

Under the terms of the agreement Curve will receive an upfront payment, and will be eligible to receive research, development and commercial milestones totalling up to US$ 1.7B should all five therapeutic programs succeed. Curve will also receive a royalty on net sales of any approved products resulting from the alliance.

Under the agreement, Curve will perform high throughput mammalian cell-based functional screening, hit characterisation, data-mining and analysis, and Microcycle optimisation. MSD will be responsible for lead optimisation, clinical development, manufacturing and commercialisation of compounds identified through the collaboration.

Simon Kerry, PhD, MBA, Chief Executive Officer of Curve, said: "This collaboration is a major milestone for Curve and an important endorsement of our ground-breaking drug discovery platform. Working with MSD on selected therapeutic targets will complement Curve’s in-house drug discovery and development programmes."

Curve’s novel, proprietary platform enables the direct discovery of biologically active molecules against targets that have been difficult to address using conventional drug discovery methods. The platform allows rapid enrichment of highly diverse Microcycle libraries in the cytoplasm of mammalian cells to identify library members that have a desired biological activity against a therapeutic target. Importantly, the compact size of Microcycles enables their transformation to non-peptidic small molecules for lead optimisation and development: an unparalleled advantage compared to other cyclic peptides.

Prof. Ali Tavassoli, Chief Scientific Officer of Curve, said: "Screening a genetically encoded Microcycle library against proteins in their native intracellular state is unique in drug discovery and Curve’s platform creates an unprecedented opportunity to discover functional hits that are readily converted to small-molecule leads against the most challenging targets in drug discovery."

Rob Garbaccio PhD., Vice President Discovery Chemistry MSD Research Laboratories said: "At MSD we are committed to bringing forward medicines for many of the world’s most challenging diseases. We look forward to collaborating with the scientists at Curve to evaluate new ways to treat complex diseases."

Curve originated from world-leading Microcycle research conducted by Professor Tavassoli’s group in the Department of Chemistry at the University of Southampton, UK. The company was established in 2019 by founding investor Advent Life Sciences and subsequently joined by co-lead Epidarex Capital.

Alkermes plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2021 and Provides Financial Expectations for 2022

On February 16, 2022 Alkermes plc (Nasdaq: ALKS) reported financial results for the quarter and year ended Dec. 31, 2021 and provided financial expectations for 2022 (Press release, Alkermes, FEB 16, 2022, View Source [SID1234608172]).

"In 2021, we made significant progress against our strategic priorities of growing our commercial business, expanding and advancing our development pipeline and driving profitability," said Richard Pops, Chief Executive Officer of Alkermes. "The year was highlighted by the FDA approval and our commercial launch of our oral atypical antipsychotic, LYBALVI, which joined ARISTADA, our long-acting injectable antipsychotic, in our psychiatry franchise. We drove new growth with VIVITROL in the alcohol dependence indication. We met important pipeline milestones, initiating potential registration-enabling studies for nemvaleukin and advancing our HDAC inhibitor and orexin development candidates. In 2022, we are focused on execution as we advance the commercial launch of LYBALVI, enroll our nemvaleukin clinical studies, demonstrate disciplined allocation of capital and manage the business to drive long-term profitability and value creation for our shareholders."

Quarter Ended Dec. 31, 2021 Financial Highlights

– Total revenues for the quarter were $324.5 million. This compared to $280.0 million for the same period in the prior year.

– Total operating expenses for the quarter were $322.1 million. This compared to $310.7 million for the same period in the prior year.

– Net income according to generally accepted accounting principles in the United States (GAAP) was $0.9 million for the quarter, or a basic and diluted GAAP earnings per share of $0.01. This compared to GAAP net loss of $42.6 million, or a basic and diluted GAAP loss per share of $0.27, for the same period in the prior year.

– Non-GAAP net income was $38.5 million for the quarter, or a non-GAAP basic earnings per share of $0.24 and diluted earnings per share of $0.23. This compared to non-GAAP net income of $16.5 million, or a non-GAAP basic and diluted earnings per share of $0.10 for the same period in the prior year.

Year Ended Dec. 31, 2021 Financial Results

Revenues

– Total revenues for the year were $1.17 billion. This compared to $1.04 billion in the prior year.

– Net sales of proprietary products for the year were $627.4 million, compared to $551.8 million in the prior year.

Net sales of VIVITROL were $343.9 million, compared to $310.7 million in the prior year, representing an increase of approximately 11%.
Net sales of ARISTADAi were $275.4 million, compared to $241.0 million in the prior year, representing an increase of approximately 14%.
Net sales of LYBALVI were $8.2 million, following commercial launch in October 2021.
– Manufacturing and royalty revenues for the year were $541.8 million, compared to $484.0 million in the prior year.

Royalty revenues from INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA (the "long-acting INVEGA products") were $303.1 million, compared to $274.2 million in the prior year.
Manufacturing and royalty revenues from RISPERDAL CONSTA were $50.9 million, compared to $71.4 million in the prior year.
Manufacturing and royalty revenues from VUMERITY were $87.4 million, compared to $22.5 million in the prior year.
Costs and Expenses

– Total operating expenses for the year were $1.20 billion, compared to $1.15 billion in the prior year.

Cost of Goods Manufactured and Sold were $197.4 million, compared to $178.3 million in the prior year.
R&D expenses were $406.5 million, compared to $394.6 million in the prior year. R&D expenses in 2021 included a $25.0 million development milestone paid to the former shareholders of Rodin Therapeutics, Inc. related to the company’s HDAC inhibitor platform. Excluding this milestone, R&D expenses for the year were $381.5 million.
Selling, General and Administrative (SG&A) expenses were $561.0 million, compared to $538.8 million in the prior year, primarily reflecting increased investment to support the launch of LYBALVI.
Profitability

– GAAP net loss for the year was $48.2 million, or a basic and diluted GAAP loss per share of $0.30 and included the $25.0 million development milestone. This compared to GAAP net loss of $110.9 million, or a basic and diluted GAAP loss per share of $0.70, in the prior year.

– Non-GAAP net income for the year was $129.1 million, or a non-GAAP basic earnings per share of $0.80 and diluted earnings per share of $0.78 and included the $25.0 million development milestone. This compared to non-GAAP net income of $68.6 million, or a non-GAAP basic and diluted earnings per share of $0.43, in the prior year.

Balance Sheet

– At Dec. 31, 2021, Alkermes recorded cash, cash equivalents and total investments of $765.7 million, compared to $659.8 million at Dec. 31, 2020, driven primarily by the company’s operating results and changes in working capital. The company’s total debt outstanding as of Dec. 31, 2021 was $295.8 million.

"In 2021, we managed the business to achieve the high end of our overall financial expectations, as we drove topline growth, continued to optimize our cost structure and focused on operational efficiencies. At the same time, we invested in key strategic priorities including the launch of LYBALVI and the nemvaleukin development program," commented Iain Brown, Chief Financial Officer of Alkermes. "We enter 2022 in a solid financial position. Our financial expectations for the year reflect our continued focus on driving the growth of our proprietary products and disciplined capital allocation focused on opportunities with high potential return on investment in support of the company’s strategy and to drive shareholder value creation."

Financial Expectations for 2022

The following financial expectations for 2022 assume improvement in COVID-19 pandemic-related disruptions, beginning in the second quarter. If current disruptions do not decrease as anticipated, or if new COVID-19-related disruptions emerge, the company’s ability to meet these expectations could be negatively impacted. These financial expectations also reflect removal of all royalties from worldwide sales of the long-acting INVEGA products beginning in 2022. Alkermes has, to date, only received notice of partial termination relating to royalties from the long-acting INVEGA products in the U.S., after January 2022. Alkermes has not received a notice of termination from Janssen in respect of any markets outside the U.S. However, for financial planning purposes only, the company has decided to remove all royalties related to sales in markets outside the U.S. after May 2022. Alkermes continues to disagree with the position taken by Janssen and is prepared to pursue all options at its disposal to enforce its contractual rights and address any unauthorized use of its intellectual property.

All line items are according to GAAP, except as otherwise noted.

In millions (except per share amounts)

2022 Expectations

*Reflects royalties related to sales of INVEGA SUSTENNA/INVEGA TRINZA/INVEGA HAFYERA in the U.S. through January 2022 and royalties related to sales of XEPLION/TREVICTA through May 2022.

+2022 per share expectations are calculated based on a weighted average basic share count of approximately 163.0 million shares outstanding and a weighted average diluted share count of approximately 166.5 million shares outstanding.

Mr. Brown continued, "Over the last several years, we have worked to position the business such that our topline performance will be fueled primarily by the growth of our proprietary products. We estimate that the early termination of the Janssen license agreement in the United States and the impact of its potential termination outside the United States would together reduce our total revenues by approximately $260 million in 2022. From an operational perspective, we have adapted our budget, recognizing that even if we are able to favorably resolve our situation with Janssen, that resolution could take time. Today we are updating our long-term profitability targets to reflect exclusion of worldwide royalties from the long-acting INVEGA products. In the event that the situation with Janssen resolves in a manner favorable to Alkermes, or Janssen does not terminate our license agreement in markets outside the U.S., we would be positioned to accelerate the achievement of these targets. The revised profitability targets that we are announcing today reflect feedback from many of our institutional shareholders, our commitment to continued expense management and our focus on driving long-term profitability."

Profitability Targets

The company today updated its long-term profitability targets to reflect the removal of all royalty revenues related to sales of the long-acting INVEGA products in the U.S. after January 2022 and outside the U.S. after May 2022. The company is not providing reconciliations of, or comparable GAAP measures for, the following updated non-GAAP profitability targets, as they are not determinable without unreasonable efforts.*

The company is committed to achieving:

FY 2025 non-GAAP net income equal to 25% of the company’s total revenues and EBITDAii margin of 20% of total revenues
FY 2026 non-GAAP net income equal to 30% of the company’s total revenues and EBITDA margin of 25% of total revenues
As a bridge to these long-term profitability targets, the company expects to achieve non-GAAP net income in the range of 15% to 20% of the company’s total revenues in FY 2024.

Recent Events:

Psychiatry and Addiction

In October 2021, the company presented clinical data and epidemiology and health economics and outcomes research from its psychiatry and addiction portfolios at scientific conferences, including Psych Congress, the International Society for Affective Disorders (ISAD) Conference, and the Neuroscience Education Institute (NEI) Congress.
In February 2022, the company announced positive topline results from ENLIGHTEN-Early, a phase 3b study that evaluated the effect of LYBALVI compared to olanzapine on body weight in patients with schizophrenia, schizophreniform disorder or bipolar I disorder who were early in their illness. The company plans to submit results from the ENLIGHTEN-Early study to a peer-reviewed journal for publication and present full study results at upcoming scientific meetings.
Oncology

In November 2021, the company presented data from the ION-01 study, a phase 2 trial evaluating intravenous nemvaleukin alfa ("nemvaleukin") in combination with pembrolizumab (KEYTRUDA) in patients with recurrent or metastatic head and neck squamous cell carcinoma that had previously progressed on an anti-PD-(L)1 therapy, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting.
In January 2022, the company presented a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium, highlighting clinical data related to advanced GI cancers from ARTISTRY-1, a phase 1/2 study evaluating the tolerability and efficacy of nemvaleukin administered intravenously as a monotherapy and in combination with pembrolizumab, and preclinical data from the study of nemvaleukin in combination with novel agents in GI cancers.
Neuroscience

In November 2021, the company announced dosing of the first subject in a phase 1 study evaluating the safety and tolerability of ALKS 1140 in healthy adults. ALKS 1140 is designed to increase functional synaptic connections and synaptic integrity in the brain.
Corporate

In November 2021, the company announced the appointment of a new independent director, Cato T. Laurencin, M.D., Ph.D., to the company’s Board of Directors. Dr. Laurencin was designated by Sarissa Capital Management LP and certain affiliates (collectively "Sarissa") in connection with Sarissa’s April 2021 agreement with the company. Dr. Laurencin brings significant experience across a wide range of medical and scientific disciplines, strong administrative skills, and a focus on public health that is consistent with the company’s values and business strategy.
Other

In November 2021, the company announced receipt of notices of partial termination in respect of two license agreements with Janssen Pharmaceutica N.V., a subsidiary of Johnson & Johnson Company and, under these agreements, a licensee and recipient of Alkermes’ nanoparticulate formulation technology, known as NanoCrystal technology. The terminations impact know-how royalties related to sales of long-acting INVEGA products and other products in the United States.
Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. GMT) on Wednesday, Feb. 16, 2022, 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 will be available from 11:00 a.m. ET (4:00 p.m. GMT) on Wednesday, Feb. 16, 2022, through Wednesday, Feb. 23, 2022, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay conference ID is 13726455.