On February 6, 2022 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that ATG-037 has received approval by the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate the Phase I STAMINA trial, a first-in-human study of ATG-037 in patients with locally advanced or metastatic solid tumors (Press release, Antengene, FEB 6, 2022, View Source [SID1234607771]). The primary objective of the study is to evaluate the safety and tolerability of ATG-037 as monotherapy and in combination with an immune checkpoint inhibitor (CPI), to determine the appropriate dose for Phase II studies, and to assess preliminary signal of activity; the secondary objective is to characterize the pharmacology of ATG-037.

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ATG-037 is an orally available, small molecule CD73 inhibitor. CD73 generates adenosine, which leads to immunosuppression in the tumor microenvironment. ATG-037 has demonstrated promising preclinical efficacy as a monotherapy and in combination with CPIs and chemotherapy agents. In preclinical studies, the compound has demonstrated to overcome the "hook effect" that is common in anti-CD73 antibodies. In addition, GLP toxicology studies indicate the compound will have a broad therapeutic window.

Kevin Lynch, M.D., Chief Medical Officer of Antengene commented, "Developing novel molecules that can make a clinical difference in cancer is of paramount importance to Antengene. Preclinical toxicology data suggests that ATG-037 will have a broad therapeutic window and further preclinical data suggests the potential for differentiated characteristics compared to other CD73 inhibitors."

Dr. Lynch continued, "While we remain very interested to explore the drug as a monotherapy, combination therapy of ATG-037 with CPIs and chemotherapies could enable synergistic improvements in tumor response for patients with advanced and metastatic cancers. ATG-037 also has the potential to be used in combination with several agents in the Antengene pipeline including ATG-101, a proprietary PD-L1/4-1BB bispecific antibody, demonstrating the in-house combinatory potential of our pipeline programs. I’m very excited about the start of the clinical program and look forward to next steps with ATG-037."

On February 6, 2022 Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, reported that the Health Sciences Authority (HSA) of Singapore has approved Trodelvy(sacituzumab govitecan or SG) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease (Press release, Everest Medicines, FEB 6, 2022, View Source [SID1234607772]). This marks the first drug approval of Trodelvy received by Everest. The Company expects a series of approvals for Trodelvy in its license territories in the coming year.

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"As part of our larger business strategy to build a robust commercial presence in Asia Pacific markets, we are well-positioned to accelerate quickly during this next phase of growth with an established commercial team, bridging the gap between patients with unmet medical needs and first-in-class biopharmaceutical innovation," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "As a next step we will be working collaboratively with all stakeholders to bring Trodelvy to women in Singapore living with metastatic TNBC."

"TNBC accounts for 15-20% of all breast cancer cases in Singapore, and breast cancer is the country’s leading cause of cancer death in women. This aggressive and difficult-to-treat form of the disease has historically had very limited treatment options, with overall survival remaining unchanged among patients for nearly two decades," said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. This regulatory milestone brings Trodelvy one step closer to Singaporean patients with metastatic TNBC."

In addition to Singapore, Everest is closely coordinating with regulatory bodies in Greater China and South Korea to review its applications for Trodelvy for adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.

In May 2021, the China National Medical Products Administration accepted its Biologics License Application for Trodelvy with priority review.
In December 2021, the Ministry of Food and Drug Safety (MFDS) of South Korea accepted a New Drug Application (NDA) for Trodelvy. Trodelvy was previously granted Fast Track Designation and Orphan Drug Designation in South Korea.
In December 2021, the Taiwan Food and Drug Administration accepted its NDA for Trodelvy. Trodelvy was previously granted Pediatric and Rare Severe Disease Priority Review Designation in Taiwan.
About Triple-Negative Breast Cancer (TNBC)

TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. The median age of breast cancer diagnoses tends to be younger in Asian than western countries, and the percentage of the TNBC molecular subtype has been increasing in the past 10 years. TNBC cells do not have estrogen and progesterone receptors and have limited human epidermal growth factor receptor 2 (HER2). Due to the nature of TNBC, effective treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer.

About Trodelvy

Trodelvy is a first-in-class antibody and topoisomerase inhibitor conjugate directed to the TROP-2 receptor, a protein overexpressed in multiple types of epithelial tumors, including metastatic TNBC and metastatic urothelial cancer (UC), where high expression is associated with poor survival and relapse. Trodelvy is approved for adults with second-line metastatic TNBC in the United States, the European Union, Australia, Canada, Great Britain and Switzerland and approval is based on data submitted from the Phase 3 ASCENT study. Review is also underway in Greater China and South Korea through Everest Medicines. Trodelvy is also approved under the accelerated approval pathway for use in metastatic UC in the United States and continues to be developed for potential use in other TNBC and metastatic UC populations. It is also being developed as an investigational treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer and metastatic non-small cell lung cancer. Additional evaluation across multiple solid tumors is also underway.

Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize SG for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries. In October 2020, SG was included in the updated 2020 China Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer, compiled by the Breast Cancer Expert Committee of the National Cancer Control Center, the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association, and the Cancer Drug Clinical Research Professional Committee of the Chinese Anti-Cancer Association.

On February 6, 2022 Ascletis Pharma Inc. (HKEX: 1672) reported the approval of the Investigational New Drug (IND) application by U.S. Food and Drug Administration (FDA) for in-house developed oral PD-L1 small molecule inhibitor, ASC61, for the treatment of advanced solid tumors (Press release, Ascletis, FEB 6, 2022, View Source [SID1234607773]). This is Ascletis’ second U.S. IND approval in 2022 after ASC22 (Envafolimab) U.S. IND approval for functional cure of chronic hepatitis B (CHB).

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The ASC61 Phase I trial in the U.S. is a dose escalation study in patients with advanced solid tumors. The objectives of such study are to find a recommended Phase II dose (RP2D) and obtain preliminary efficacy in patients with advanced solid tumors. The first U.S. patient is expected to be dosed in the first half of 2022.

ASC61 is an oral potent and highly selective PD-L1 small molecule inhibitor and blocks PD-1/PD-L1 interaction through inducing PD-L1 dimerization and internalization. As a single agent, ASC61 demonstrated significant antitumor efficacy in multiple animal models such as the humanized mouse model. Preclinical studies showed that ASC61 has good safety and pharmacokinetic profiles in animal models.

ASC61 oral tablets, which will be used in the clinical trial, were developed with the in-house proprietary technology.

Compared to injectable PD-1/PD-L1 antibodies, ASC61, as an oral PD-L1 inhibitor, has the following benefits: (1) ease of dosing and no need for hospital visits for injections; (2) all-oral combinations with other oral anti-tumor drugs; and (3) rapid titration of doses for better management of immune-related adverse events (irAEs).

"We are excited about U.S. IND approval of ASC61," said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis, "This IND approval demonstrates Ascletis’ global R&D capability in oncology. As we are advancing the phase III clinical trial of ASC40, a fatty acid synthase (FASN) inhibitor, in combination with Bevacizumab for the treatment of recurrent glioblastoma (rGBM), this U.S. IND approval is another significant milestone for Ascletis’ oncology pipeline. Furthermore, we are exploring opportunities for all-oral combinations between oral PD-L1 small molecule inhibitor ASC61 and ASC40 as well as other oral anti-tumor drugs from our business partners."

On February 6, 2022 Statera Biopharma, Inc. (NASDAQ: STAB) (the "Company" or "Statera Biopharma"), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, reported that it entered into a securities purchase agreement with a certain institutional investor to purchase approximately $2.0 million worth of its common stock and warrants in a registered direct offering (Press release, Cleveland BioLabs, FEB 6, 2022, View Source [SID1234607784]).

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Under the terms of the securities purchase agreement, the Company has agreed to sell approximately 2.0 million shares of its common stock and warrants to purchase approximately 2.0 million shares of common stock. The warrants will be exercisable immediately, have an exercise price of $1.00 per share, and will expire five years from the initial exercise date. The purchase price for one share of common stock and one warrant will be $1.00.

The gross proceeds to the Company from the registered direct offering are estimated to be approximately $2.0 million, before deducting the placement agent’s fees and other estimated offering expenses. The offering is expected to close on or about February 9, 2022, subject to the satisfaction of customary closing conditions.

EF Hutton, division of Benchmark Investments, LLC, is acting as exclusive placement agent for the offering. Bridgeway Capital Partners is acting as the Company’s financial advisor.

Anthony L.G., PLLC is acting as legal counsel to Statera Biopharma, Inc. and Carmel, Milazzo & Feil LLP is acting as legal counsel to EF Hutton for the offering.

The proposed offering of the common stock and warrants described above is being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-238578) filed with the Securities and Exchange Commission (SEC) and declared effective by the SEC on May 29, 2020, and the accompanying prospectus contained therein.

The offering is being made only by means of a prospectus supplement and accompanying prospectus. A prospectus supplement describing the terms of the public offering will be filed with the SEC and will form a part of the effective registration statement.

Copies of the prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, on the SEC’s website at View Source or by contacting EF Hutton, division of Benchmark Investments, LLC Attention: Syndicate Department, 590 Madison Avenue, 39th Floor, New York, NY 10022, by email at [email protected], or by telephone at (212) 404-7002.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 4, 2022 Bristol Myers Squibb (NYSE:BMY) today reports results for the fourth quarter and full year of 2021, which reflect strong sales driven by robust commercial execution and significant advancement of the company’s pipeline that further progressed the company’s portfolio renewal.

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"I am proud of how our company performed in 2021, helping more patients across our therapeutic areas, while achieving 9% revenue and 17% non-GAAP EPS growth, respectively," said Giovanni Caforio, M.D., board chair and chief executive officer, Bristol Myers Squibb. "2021 was a pivotal year for our company as we achieved significant regulatory and clinical milestones and positioned the company to successfully renew our portfolio. I am confident in our ability to execute against our key milestones in 2022, including three planned first-in-class launches with relatlimab plus nivolumab fixed dose combination, mavacamten and deucravacitinib. Our financial strength, dedicated workforce and proven ability to execute will enable us to continue to advance our pipeline, invest in future sources of innovation and position the company for sustained growth."

FOURTH QUARTER FINANCIAL RESULTS

All comparisons are made versus the same period in 2020 unless otherwise stated.

Bristol Myers Squibb posted fourth quarter revenues of $12.0 billion, an increase of 8%, driven by Eliquis,our Immuno-Oncology and new product portfolios.
U.S. revenues increased 11% to $7.5 billion in the quarter. International revenues increased 4% to $4.5 billion in the quarter. When adjusted for foreign exchange impact, international revenues increased 7%.
Gross margin increased from 73.7% to 80.3% in the quarter primarily due to an impairment charge related to marketed product rights in the same period a year ago and lower unwinding of inventory purchase price accounting adjustments.
On a non-GAAP basis, gross margin increased from 79.8% to 80.3% in the quarter primarily driven by foreign exchange and lower royalties.
Marketing, selling and administrative expenses decreased 13% to $2.4 billion in the quarter primarily due to cash settlement of MyoKardia unvested stock awards in the prior year, and certain incremental and accelerated investments to support our business in 2020, partially offset by investments to support new product launches.
On a non-GAAP basis, marketing, selling and administrative expenses decreased 5% in the quarter primarily due to certain incremental and accelerated investments to support our business in 2020, partially offset by investments to support new product launches.
Research and development expenses decreased 30% to $2.6 billion in the quarter. The same period a year ago included license and acquisition charges related to Dragonfly, an in-process research and development (IPR&D) impairment charge and cash settlement of MyoKardia unvested stock awards.
On a non-GAAP basis, research and development expenses increased 3% to $2.6 billion in the quarter primarily due to higher costs related to investments in the overall portfolio.
Amortization of acquired intangible assets decreased 4% to $2.4 billion in the quarter primarily due to an extended marketed product rights exclusivity period.
The effective tax benefit rate was 27.7% in the quarter. Income tax benefit was approximately $510 million despite pre-tax earnings of $1.9 billion in the quarter primarily due to the impact of internal transfers of certain intangible assets of $1.0 billion.
On a non-GAAP basis, the effective tax rate decreased 0.5% to 15.0% in the quarter primarily due to earnings mix.
The company reported net earnings attributable to Bristol Myers Squibb of $2.4 billion, or $1.07 per share, in the fourth quarter, compared to net loss of $10.0 billion, or $(4.45) per share, for the same period a year ago. In addition to the items discussed above, the results in the same period a year ago included an IPR&D charge related to the MyoKardia asset acquisition of $11.4 billion and the impact of fair value adjustments on equity investments and contingent value rights in both periods.
The company reported non-GAAP net earnings attributable to Bristol Myers Squibb of $4.1 billion, or $1.83 per share, in the fourth quarter, compared to non-GAAP net earnings of $3.3 billion, or $1.46 per share, for the same period a year ago.
A discussion of the non-GAAP financial measures is included under the "Use of Non-GAAP Financial Information" section.

*In excess of +100%.
** Included as part of the new product portfolio
***Included as part of the key loss of exclusivity (LOE) brands

*In excess of +100%.
**Included as part of the new product portfolio
***Included as part of the key loss of exclusivity (LOE) brands

FOURTH QUARTER PRODUCT AND PIPELINE UPDATE

Cardiovascular

mavacamten

Regulatory

In November, the company announced that the U.S. Food and Drug Administration (FDA) has extended the review of the New Drug Application (NDA) for mavacamten for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy to April 28, 2022. The extension will allow sufficient time to review information pertaining to updates of the proposed Risk Evaluation Mitigation Strategy (REMS). A REMS program was included in the initial application for mavacamten. No additional data or studies have been requested. (link)
Cardiovascular Portfolio

Medical Meetings

In November, the company presented new data from across its cardiovascular portfolio (link) at the American Heart Association’s (AHA) annual Scientific Sessions, including results from: the:
Phase 2 AXIOMATIC-TKR trial that showed milvexian reduced the risk of postoperative venous thromboembolism in a dose dependent manner without increasing the risk of bleeding compared with enoxaparin in patients undergoing total knee replacement surgery. The study was conducted by The Bristol Myers Squibb-Janssen Collaboration. (link)
Oncology

Opdivo

Clinical

In November, the company announced that the Phase 3 CheckMate -816 trial met the co-primary endpoint of improved event-free survival (EFS) in patients with resectable Stage IB to IIIA non-small cell lung cancer. In a prespecified interim analysis, Opdivo(nivolumab) plus chemotherapy showed a statistically significant and clinically meaningful improvement in EFS compared to chemotherapy alone when given before surgery. This combination previously showed a significant improvement of pathologic complete response, the trial’s other primary endpoint. (link)
Hematology

Breyanzi

Regulatory

In January, the company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Breyanzi (lisocabtagene maraleucel) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B after at least two prior therapies. The recommendation is based on results from TRANSCEND NHL 001 and data from the TRANSCEND WORLD study. (link)
Reblozyl

Regulatory

In December, the company announced two regulatory applications for Reblozyl (luspatercept-aamt) have been accepted. The FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for Reblozyl for the treatment of anemia in adults with non-transfusion dependent (NTD) beta thalassemia. The FDA has set a PDUFA goal date of March 27, 2022. The EMA also validated the Type II variation for Reblozyl for NTD beta thalassemia. The applications are based on results from the Phase 2 BEYOND trial. (link)
Hematology Portfolio

Medical Meetings

In December, the company announced new data and analyses from across its hematology portfolio (link) that were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, including results from the:
Phase 3 TRANSFORM trial, which showed Breyanzisignificantly improved EFS compared to chemotherapy plus autologous stem cell transplant as second line treatment in adults with relapsed or refractory large B-cell lymphoma. (link)
Immunology

Orencia

Regulatory

In December, the company announced that Orencia (abatacept) was approved by the FDA for the prophylaxis, or prevention, of acute graft versus host disease, in combination with a calcineurin inhibitor and methotrexate, in patients 2 years of age and older undergoing hematopoietic stem cell transplantation from a matched or 1 allele-mismatched unrelated donor. The approval is based on results from the Phase 2 GVHD-1 trial, also known as ABA2, and a non-interventional (observational) study known as GVHD-2. (link)
Zeposia

Regulatory

In November, the company announced that the European Commission (EC) approved Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. The EC’s decision is based on results from the Phase 3 True North trial. (link)
deucravacitinib

Regulatory

In November, the company announced three regulatory applications for deucravacitinib have been accepted for review. The FDA has accepted the NDA and the EMA has validated the Marketing Authorization Application for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis. The FDA has assigned a PDUFA goal date of September 10, 2022. Japan’s Ministry of Health, Labour and Welfare also accepted the NDA for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis, pustular psoriasis and erythrodermic psoriasis. The applications are based on the Phase 3 POETYK PSO-1 and POETYK PSO-2 trials. (link)
Environmental, Social & Governance (ESG)

In December, the company issued its 2021 Global Access Report that detailed Bristol Myers Squibb’s efforts and progress towards advancing access to healthcare and health equity globally through its own efforts and in partnership with other stakeholders. (link)

Business Development

In January, the company and Century Therapeutics (NASDAQ: IPSC) announced a research collaboration and license agreement to develop and commercialize up to four induced pluripotent stem cell derived, engineered natural killer cell and / or T cell programs for hematologic malignancies and solid tumors. (link)
In December, the company and Immatics N.V. (NASDAQ: IMTX, "Immatics"), announced that they have entered into a license, development and commercialization agreement for Immatics’ TCR Bispecific candidate, IMA401. (link)
Capital Allocation

The company continues to maintain a consistent, balanced approach to capital allocation focused on prioritizing investment for growth through business development along with reducing debt, commitment to dividend growth and share repurchase.

In December, the company announced that its Board of Directors approved an increase in the quarterly dividend and authorized an additional $15 billion, multi-year share repurchase program. (link) As part of that program, in January, the company announced that it plans to execute an accelerated share repurchase agreement during the first quarter of 2022 to repurchase up to $5 billion of Bristol Myers Squibb common stock. (link)
Financial Guidance

Bristol Myers Squibb is introducing its 2022 GAAP EPS guidance range of $3.37 – $3.67 and reaffirming its non-GAAP EPS guidance range of $7.65 – $7.95. Both GAAP and non-GAAP guidance assume current exchange rates. Key 2022 GAAP and non-GAAP line-item guidance assumptions are:

Worldwide revenues are expected to be approximately $47 billion, representing an increase in the low-single digits.
Sales from key loss of exclusivity (LOE) brands, which represent Revlimid and Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), are expected to be approximately $10.5 billion. Revlimid sales are expected to be $9.5-$10 billion.
Our Continuing Business, which represents in-line products and new product portfolio, is expected to grow in the low-double digits and contribute approximately $36.5 billion in 2022.
Gross margin is expected to be approximately 78% for GAAP and for non-GAAP.
Operating expenses, consisting of marketing, selling and administrative expenses and research and development expenses, are expected to decrease by approximately 10% for GAAP and be in-line with 2021 levels for non-GAAP.
An effective tax rate of approximately 24% for GAAP and approximately 16.5% for non-GAAP.
The 2022 financial guidance excludes the impact of any potential future strategic acquisitions and divestitures, and any specified items that have not yet been identified and quantified. The 2022 non-GAAP EPS guidance is further explained under "Use of Non-GAAP Financial Information." The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this press release.

Reaffirms Long-Term Financial Targets

Bristol Myers Squibb is also reaffirming its previously communicated 2020-2025 long-term targets:

Expects low- to mid-single digit revenue CAGR and low double-digit revenue CAGR for our Continuing Businessat constant exchange rates
Expects to maintain low- to mid-40s percent non-GAAP operating margin
Expects significant free cash flow generation of $45-$50 billion dollars from 2022-2024
This financial guidance excludes the impact of any potential future strategic acquisitions and divestitures as well as any specified items as discussed under "Use of Non-GAAP Financial Information." There is no reliable or reasonably estimable comparable GAAP measures for this non-GAAP financial guidance. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this press release.

Company and Conference Call Information

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram.

There will be a conference call on February 4, 2022 at 8 a.m. ET during which company executives will review financial information and address inquiries from investors and analysts. Investors and the general public are invited to listen to a live webcast of the call at View Source or by using this link which becomes active 15 minutes prior to the scheduled start time and entering your information to be connected.

Investors and the public can also access the live webcast by dialing in the U.S. toll free 877-502-9276 or international +1 313-209-4906, confirmation code: 2150568. Materials related to the call will be available at the same website prior to the conference call.

A replay of the webcast will be available on View Source approximately three hours after the conference call concludes. A replay of the conference call will be available beginning at 11:30 a.m. ET on February 4 through 11:30 a.m. ET on February 18, 2022 by dialing in the U.S. toll free 888-203-1112 or international +1 719-457-0820, confirmation code: 2150568.

Corporatefinancial-news

Use of Non-GAAP Financial Information

In discussing financial results and guidance, the company refers to financial measures that are not in accordance with U.S. Generally Accepted Accounting Principles (GAAP). The non-GAAP financial measures are provided as supplemental information to the financial measures presented in this press release that are calculated and presented in accordance with GAAP and are presented because management has evaluated the company’s financial results both including and excluding the adjusted items or the effects of foreign currency translation, as applicable, and believes that the non-GAAP financial measures presented portray the results of the company’s baseline performance, supplement or enhance management, analysts and investors overall understanding of the company’s underlying financial performance and trends and facilitate comparisons among current, past and future periods. This information is among the primary indicators that we use as a basis for evaluating performance, allocating resources, setting incentive compensation targets and planning and forecasting for future periods. In addition, non-GAAP gross margin, which is gross profit excluding certain specified items as a percentage of revenues, non-GAAP operating margin, which is operating income excluding certain specified items as a percentage of revenues; non-GAAP free cash flow, which is non-GAAP net earnings plus adjustments related to cash generated from operating activities and cash paid for capital expenditures; non-GAAP marketing, selling and administrative expenses, which is marketing, selling and administrative expense excluding certain specified items, and non-GAAP research and development expenses, which is research and development expenses excluding certain specified items, are relevant and useful for investors because they allow investors to view performance in a manner similar to the method used by our management and make it easier for investors, analysts and peers to compare our operating performance to other companies in our industry and to compare our year-over-year results.

This earnings release and the accompanying tables also provide certain revenues and expenses as well as non-GAAP measures excluding the impact of foreign exchange. We calculate foreign exchange impacts by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results.

Non-GAAP financial measures such as non-GAAP earnings and related EPS information are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of past or future operating results. These items are excluded from non-GAAP earnings and related EPS information because the company believes they neither relate to the ordinary course of the company’s business nor reflect the company’s underlying business performance. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods, including amortization of acquired intangible assets, including product rights that generate a significant portion of our ongoing revenue and will recur until the intangible assets are fully amortized, unwind of inventory purchase price adjustments, acquisition and integration expenses, restructuring costs, accelerated depreciation and impairment of property, plant and equipment and intangible assets, R&D charges or other income resulting from up-front or contingent milestone payments in connection with the acquisition or licensing of third-party intellectual property rights, divestiture gains or losses, stock compensation resulting from accelerated vesting of Celgene awards, certain retention-related employee compensation charges related to the Celgene transaction, pension, legal and other contractual settlement charges, equity investment and contingent value rights fair value adjustments (including fair value adjustments attributed to limited partnership equity method investments beginning in 2021) and amortization of fair value adjustments of debt acquired from Celgene in our 2019 exchange offer, among other items. Certain other significant tax items are also excluded such as the impact resulting from internal transfers due to streamlining our legal entity structure subsequent to the Celgene acquisition and the global intangible low taxed income tax change upon finalization of the Otezla* divestiture in 2020. Deferred and current income taxes attributed to these items are also adjusted for considering their individual impact to the overall tax expense, deductibility and jurisdictional tax rates.

Because the non-GAAP financial measures are not calculated in accordance with GAAP, they should not be considered superior to and are not intended to be considered in isolation or as a substitute for the related financial measures presented in the press release that are prepared in accordance with GAAP and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.

Reconciliations of the non-GAAP financial measures to the most comparable GAAP measures are provided in the accompanying financial tables and also available on the company’s website at www.bms.com. Within the attached financial tables presented, certain columns and rows may not add due to the use of rounded numbers. Percentages and earnings per share amounts presented are calculated from the underlying amounts.

Also note that a reconciliation of the forward-looking revenue (ex-FX), free cash flow and non-GAAP operating margin measures is not provided due to the inherent difficulty in forecasting and quantifying items that are necessary for such reconciliation. Namely, we are not able to reliably predict the impact of specified items or currency exchange rates beyond the next twelve months. As a result, the reconciliation of these non-GAAP measures to the most directly comparable GAAP measures is not available without unreasonable effort. In addition, the company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. The variability of the specified items may have a significant and unpredictable impact on our future GAAP results.

Website Information

We routinely post important information for investors on our website, BMS.com, in the "Investors" section. We may use this website as a means of disclosing material, non-public information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investors section of our website, in addition to following our press releases, SEC filings, public conference calls, presentations and webcasts. We may also use social media channels to communicate with our investors and the public about our company, our products and other matters, and those communications could be deemed to be material information. The information contained on, or that may be accessed through, our website or social media channels are not incorporated by reference into, and are not a part of, this document.