On April 29, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to improve drug discovery and development and identify patients who will benefit from its portfolio of targeted oncology therapeutics, reported that RADR has exceeded 4.6 billion datapoints (Press release, Lantern Pharma, APR 29, 2021, View Source;utm_medium=rss&utm_campaign=radr-surpasses-4-6-billion-datapoints-accelerating-progress [SID1234578775]). This 16-fold increase in datapoints over the past 12 months was also accompanied by other significant improvements in the functionality, feature-set and automation of the drug development platform as well as a significant increase in the number of drugs, drug classes and cancers covered by RADR.

"We are extremely pleased to share the fact that we have increased the number of biologically relevant and curated datapoints that power our RADR platform by 16-fold since last May and nearly 4-fold since the beginning of the year. The pace of data acquisition, curation, and tagging achieved during this last campaign is well ahead of schedule and allows us to increasingly focus on building a more complete and more powerful library of algorithms and machine learning models aimed at rapidly answering questions that are fundamental to oncology drug development," stated Panna Sharma, President and CEO of Lantern Pharma. "Our mission to build the world’s largest, most robust and most accurate A.I. driven platform for precision oncology drug discovery and development is advancing rapidly. The robustness of the datasets powering RADR is anticipated to continue to improve machine-learning results, accelerate automation of other features and aid oncology drug development for Lantern and our partners with the ultimate focus of benefitting cancer patients."

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Lantern is committed to growing and enhancing RADR, which it believes is among the largest drug development platforms powered exclusively for oncology drug development and rescue. The growing datapoints, and accompanying functionality in the A.I. platform, allow scientists, biologists, and engineers to collaborate on issues of drug activity, drug response, patient stratification, and cancer biomarkers at a pace which has been unachievable, until now. The developmental focus on increasing the number of datapoints, and improving the performance, power and biological relevance of the algorithms, is expected to yield additional targeted indications for Lantern’s current pipeline of drug candidates. We expect that the platform will also help in revealing additional compounds and therapies that can be in-licensed and subsequently developed in a more efficient, and potentially more targeted manner. Lantern has used RADR to uncover indications in multiple cancer sub-types, including CNS (central nervous system) cancers, drug-resistant lung cancers, lung cancer sub-types among never-smokers and SMARCB1 mutated cancers (e.g. Atypical Teratoid Rhabdoid Tumors).

Lantern has filed two additional patent applications directed to the RADR platform that further strengthen the Company’s leading position in using A.I. for cancer drug development and drug rescue. The Company’s patent applications are directed to using machine learning to predict and discover gene signatures associated with pharmaceutical agents, as well as using automated and machine learning methods on genomic and biomarker data for rescuing, repurposing and repositioning of pharmaceutical agents. Lantern expects to continue developing novel A.I. and machine learning functionality, methods and technologies that it will file patents on both as core technologies and directed in the use of its pipeline of drug candidates.

"As A.I. continues to transform drug development, platforms that can provide a machine-learning, A.I. driven edge are becoming an essential tool for companies to make informed, rapid decisions in cancer indication selection, trial design, validation of mechanisms and potential creation of combination therapy regimens," continued Sharma. "Now, with every major cancer and drug class being covered in our A.I. platform, Lantern can focus not only on accelerating our portfolio, but also on developing collaborations that continue to enhance and validate our platform while delivering insights for our biopharma partners. These RADR powered insights are expected to accelerate development timelines, derisk key decisions and uncover new opportunities that may have gone undeveloped — ultimately leading to oncology therapies that can increase the personalization of treatment."

"Biopharma companies are looking to launch programs in validated indications more rapidly as they focus on maximizing the potential of each drug candidate," said Mr. Sharma. "We believe that RADR can help design and launch these programs, that continue to grow in complexity, at a fraction of the cost and timeline of traditional oncology drug development. Creating novel genomic and mechanistic insights while also providing specific guidance on designing biomarker driven preclinical studies and clinical trials is an essential component of personalizing cancer treatment. RADR is a powerful platform that can offer a significant competitive advantage for oncology drug development."

On April 29, 2021 Bristol Myers Squibb (NYSE:BMY) reported results for the first quarter of 2021, which reflect continued sales growth and advancement of the company’s product pipeline across our four core therapeutic areas (Press release, Bristol-Myers Squibb, APR 29, 2021, View Source [SID1234578792]).

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"We continue to deliver solid growth, execute against our strategic priorities and make meaningful progress across our pipeline," said Giovanni Caforio, M.D., board chair and chief executive officer, Bristol Myers Squibb. "I am proud of our team’s hard work and dedication, which led to important milestones with significant potential to benefit patients across multiple disease states. These accomplishments, combined with our financial strength and flexibility, further advance our opportunity to renew our portfolio and drive long-term sustainable growth."

FIRST QUARTER FINANCIAL RESULTS

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

Bristol Myers Squibb posted first quarter revenues of $11.1 billion, an increase of 3%, or 1% when adjusted for foreign exchange. Excluding COVID-19 related buying patterns from the prior year period, first quarter revenues grew 8%.
U.S. revenues increased 4% to $7.0 billion in the quarter. International revenues increased 1% to $4.1 billion in the quarter. When adjusted for foreign exchange impact, international revenues decreased 5%.
Gross margin increased from 66.0% to 74.3% in the quarter primarily due to lower unwinding of inventory purchase price accounting adjustments, partially offset by an impairment charge related to the Inrebic marketed product rights and foreign exchange. On a non-GAAP basis, gross margin decreased from 79.4% to 78.1% in the quarter driven by foreign exchange.
Marketing, selling and administrative expenses increased 4% to $1.7 billion in the quarter primarily due to higher advertising and promotion expenses. On a non-GAAP basis, marketing, selling and administrative expenses increased 5% to $1.7 billion in the quarter primarily due to higher advertising and promotion expenses.
Research and development expenses decreased 6% to $2.2 billion in the quarter primarily due to lower site exit costs and license and asset acquisition charges and other specified items related to the Celgene acquisition in the same period a year ago. On a non-GAAP basis, research and development expenses decreased 1% to $2.2 billion.
Amortization of acquired intangible assets increased $231 million to $2.5 billion in the quarter.
The effective tax rate was 19.8% in the quarter. Income taxes were $462 million despite a pre-tax loss of $304 million in the same period a year ago primarily due to certain non-deductible expenses and purchase price adjustments. On a non-GAAP basis, the effective tax rate was 16.8% in the quarter and 16.0% in the same period a year ago.
The company reported net earnings attributable to Bristol Myers Squibb of $2.0 billion, or $0.89 per share, in the first quarter, compared to net loss of $775 million, or $0.34 per share, for the same period a year ago.
The company reported non-GAAP net earnings attributable to Bristol Myers Squibb of $4.0 billion, or $1.74 per share, in the first quarter, compared to non-GAAP net earnings of $4.0 billion, or $1.72 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.

FIRST QUARTER PRODUCT AND PIPELINE UPDATE

Cardiovascular

mavacamten

Regulatory

In March, the company announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for mavacamten, an investigational, novel, oral, allosteric modulator of cardiac myosin, for patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of January 28, 2022. (link)
Oncology

Opdivo

Regulatory

In April, the company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) plus Yervoy(ipilimumab) for the first-line treatment of adults with unresectable malignant pleural mesothelioma (MPM). The positive CHMP opinion is based on results from CheckMate -743, which demonstrated superior overall survival with Opdivo plus Yervoy vs. chemotherapy. (link)
In April, the company announced the FDA approved Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, regardless of PD-L1 expression status. The approval is based on results from the CheckMate -649 trial. (link)
In April, the company announced that the European Commission (EC) has approved Opdivo in combination with Cabometyx (cabozantinib) for the first-line treatment of adults with advanced renal cell carcinoma. The EC’s decision is based on results from the Phase 3 CheckMate -9ER trial, which demonstrated superior efficacy with Opdivo in combination with Cabometyx vs. sunitinib. (link)
In March, the company announced that the EMA has validated its type II variation application for Opdivo for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma. The application is based on results from the CheckMate -274 trial, which showed that Opdivo increased disease-free survival and was well tolerated by patients. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process. (link)
In February, the company announced that the CHMP of the EMA has recommended approval of Opdivo in combination with Cabometyx for the first-line treatment of adults with advanced RCC. The recommendation is based on the Phase 3 CheckMate -9ER trial and the European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation. (link)
Clinical

In April, the company announced results from the CheckMate -648 study, evaluating treatment with Opdivo plus chemotherapy or Opdivo plus Yervoy in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). The study showed statistically significant and clinically meaningful improvements in: overall survival in patients whose tumors expressed PD-L1 with both Opdivo plus Yervoy and Opdivo plus chemotherapy; overall survival in the all-randomized patient population with both Opdivo plus Yervoy and Opdivo plus chemotherapy; and progression-free survival in patients whose tumors express PD-L1 with Opdivo plus chemotherapy. The study did not meet the endpoint of progression-free survival in patients whose tumors express PD-L1 with use of Opdivo plus Yervoy. (link)
relatlimab

Clinical

In March, the company announced primary results from the Phase 2/3 RELATIVITY-047 (CA224-047) trial evaluating the fixed-dose combination of relatlimab, an anti-LAG-3 antibody, and Opdivo versus Opdivo alone in patients with previously untreated metastatic or unresectable melanoma. The trial met its primary endpoint of progression-free survival (PFS). (link)
Medical Conferences

In April, during a plenary session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021:
The company announced results from the CheckMate -816 study, which showed that neoadjuvant treatment with three cycles of Opdivo plus chemotherapy significantly improved pathologic complete response (pCR), a primary endpoint, compared to chemotherapy alone in patients with resectable stage Ib to IIIa non-small cell lung cancer (NSCLC). (link)
In February during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Genitourinary Cancers Symposium:
The company announced results from the Phase 3 CheckMate -274 trial, which showed that Opdivo significantly improved disease-free survival (DFS) as an adjuvant treatment across all randomized patients with surgically resected, high-risk muscle-invasive urothelial carcinoma and in the subgroup of patients whose tumors express PD-L1 ≥1%, meeting both of the study’s primary endpoints. CheckMate -274 is the first positive Phase 3 trial evaluating an immunotherapy in the adjuvant setting of muscle-invasive urothelial carcinoma. (link)
The company and Exelixis, Inc.(NASDAQ: EXEL) announced results from new analyses from the Phase 3 CheckMate -9ER trial, demonstrating clinically meaningful, sustained efficacy benefits as well as quality of life improvements with the combination of Opdivo and Cabometyx compared to sunitinib in the first-line treatment of advanced RCC. (link)
Hematology

Onureg

Regulatory

In April, the company announced that CHMP of the EMA has recommended approval of Onureg (azacitidine tablets; CC-486) as a maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT). (link)
Abecma

Regulatory

In March, the company and bluebird bio, Inc. (NASDAQ: BLUE) announced that the FDA has approved Abecma(idecabtagene vicleucel; ide-cel) as the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. (link)
Breyanzi

Regulatory

In February, the company announced that the FDA has approved Breyanzi (lisocabtagene maraleucel: liso-cel), a CD19-directed CAR T cell therapy for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma(LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. (link)
Inrebic

Regulatory

In February, the company announced that the European Commission (EC) has granted full Marketing Authorization for Inrebic (fedratinib) for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis, who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib. (link)
Immunology

deucravacitinib

Medical Conferences

In April, at the American Academy of Dermatology Virtual Meeting Experience (AAD VMX), the company announced positive results from the POETYK PSO-1 and POETYK PSO-2 Phase 3 trials evaluating deucravacitinib, a potential first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action, for the treatment of patients with moderate to severe plaque psoriasis.(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 and share repurchases.

In March, the company purchased approximately $4.0 billion in aggregate purchase price of certain debt securities in a series of cash tender offers and "make whole" redemptions.
Commitment to Environmental Sustainability, Diversity and Inclusion, Health Equity

In February, the company announced the donation of a total of $11 million to 56 nonprofit organizations focused on advancing health equity in the United States. These organizations will deliver programs to improve access to high-quality care as well as increase disease awareness and education in racially and ethnically diverse and medically underserved communities, and to improve diversity in clinical research. (link)
COVID-19 Pandemic Response

During the current world health crisis, the company continues to take all necessary actions to promote public health by carrying out its mission of providing life-saving medicines to the patients who depend on the company, conducting research and supporting relief efforts across the globe. (link)

Financial Guidance

Bristol Myers Squibb is updating its 2021 GAAP EPS guidance range of $3.12-$3.32 to $3.18-$3.38 and affirming its non-GAAP EPS guidance range of $7.35 – $7.55. Both GAAP and non-GAAP guidance assume current exchange rates. Key 2021 GAAP and non-GAAP line item guidance assumptions are:

Worldwide revenues increasing in the high-single digits.
Gross margin as a percentage of revenue is expected to be approximately 79% for GAAP and approximately 80.5% for non-GAAP.
Marketing, selling and administrative expenses to be in-line with 2020 levels for GAAP and increasing in the low-single digit range for non-GAAP.
Research and development expenses decreasing in the low-double digits for GAAP and increasing in the mid-single digits for non-GAAP.
An effective tax rate of approximately 22% for GAAP and approximately 16% for non-GAAP.
The 2021 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 2021 non-GAAP EPS guidance is explained and further excludes other specified items as discussed 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.

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 April 29, 2021 at 9 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 dialing in the U.S. toll free 800-458-4121 or international +1 313-209-6672, confirmation code: 3705525, or using this link which becomes active 15 minutes prior to the scheduled start time and entering your information to be connected. Materials related to the call will be available at the same website prior to the conference call.

A replay of the call will be available beginning at 12:30 p.m. ET on April 29 through 12:30 p.m. ET on May 13, 2021. The replay will also be available through View Source or by dialing in the U.S. toll free 888-203-1112 or international 719-457-0820, confirmation code: 3705525.

Use of Non-GAAP Financial Information

In discussing financial results and guidance, the company refers to the 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. For example, non-GAAP earnings and EPS information are indications of the company’s baseline performance before items that are considered by us to not be reflective of the company’s ongoing results. 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, revenue excluding COVID-19 related buying patterns from the first quarter of 2020, non-GAAP gross margin, which is gross profit excluding certain specified items as a percentage of revenues, 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 also provides international revenues excluding the impact of foreign exchange. Foreign exchange impacts were derived by applying the prior period average currency rates to the current period revenues and expenses.

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 fair value 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 upfront 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. 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.

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.

On April 29, 2021 Baxter International Inc. (NYSE:BAX), a leading global medical products company, reported results for the first quarter of 2021 (Press release, Baxter International, APR 29, 2021, View Source [SID1234578835]).

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"Baxter’s medically essential products are fundamental to healthcare, and many have proven pivotal in the fight against COVID-19," said José (Joe) E. Almeida, chairman, president and chief executive officer. "Our life-sustaining portfolio, broad geographic reach and the ongoing momentum of our business transformation are all keys to our resilience. We are well positioned to strengthen our impact in the year ahead, fueled by our innovative product pipeline, relentless focus on execution, and capital deployment opportunities to benefit patients, customers and investors."

First-Quarter Financial Results

Worldwide sales in the first quarter totaled approximately $2.9 billion, an increase of 5% on a reported basis and 1% on both a constant currency and operational basis. Operational sales in the first quarter exclude the impact of foreign exchange and the company’s recent acquisition of the rights to Caelyx and Doxil, the branded versions of liposomal doxorubicin, for specified territories outside of the United States (OUS).

Sales in the U.S. totaled $1.2 billion, decreasing 3% on both a reported and operational basis. International sales of $1.8 billion increased 11% on a reported basis, 5% on a constant currency basis and 4% on an operational basis.

Starting this quarter, Baxter is adding the sales of its BioPharma Solutions contract manufacturing unit to its financial schedules, which break out sales by key product category. Historical schedules reflecting this new structure are available on Baxter’s Investor Relations website.

Performance in the first quarter was driven by Acute Therapies which delivered significant growth at both reported and constant rates, reflecting sustained higher levels of product demand due to the ongoing COVID-19 pandemic. BioPharma Solutions also delivered double-digit growth at reported and constant rates, driven by multiple collaborations to help manufacture COVID-19 vaccines on a contract basis. Additionally, Clinical Nutrition, Pharmaceuticals and Renal Care grew mid- to high single digits at reported rates, and low single digits at constant rates. This helped offset declines in Medication Delivery and Advanced Surgery, reflecting lower rates of hospital admissions and elective surgeries, respectively, in the wake of the ongoing pandemic, as well as a challenging comparison to performance in the previous year’s quarter.

Please see the attached schedules accompanying this press release for additional details on sales performance in the quarter, including breakouts by Baxter’s key product categories and geographic segments.

For the first quarter, net income attributable to Baxter was $298 million, or $0.58 per diluted share, a decline of 9% on a U.S. GAAP (Generally Accepted Accounting Principles) basis. These results include special items totaling $88 million after-tax, which were primarily related to intangible asset amortization, business optimization charges, and a proposed settlement of shareholder litigation related to the company’s investigation of foreign exchange gains and losses associated with certain intra-company transactions. On an adjusted basis, net income attributable to Baxter totaled $386 million, or $0.76 per diluted share, a 7% decline for the quarter. This exceeded the company’s previously issued guidance range of $0.63 to $0.65, driven by operational strength and a lower tax rate.

Business Highlights2

Baxter continues to achieve notable strategic milestones in pursuit of its Mission to Save and Sustain Lives. Among recent highlights, the company:

Received U.S. FDA 510(k) clearance for its AK 98 (Artificial Kidney 98) dialysis machine, designed to be a portable and easy-to-use system to administer hemodialysis treatments. Among its features, AK 98 offers encrypted, two-way connectivity, which enables the system to pull prescriptions directly from the electronic medical record (EMR) for simplified workflow and data handling.
Resubmitted to the U.S. FDA for 510(k) clearance of Baxter’s leading-edge Novum IQ Infusion platform. The platform includes both large volume and syringe infusion pumps, and features Baxter’s Dose IQ Safety Software and IQ Enterprise Connectivity Suite, intuitive digital health technologies developed to protect patients, manage devices and provide advanced insights.
Announced an agreement with Moderna, Inc., for Baxter BioPharma Solutions to provide fill/finish sterile manufacturing services and supply packaging for approximately 60 to 90 million doses of the Moderna COVID-19 vaccine in 2021. This partnership follows earlier agreements announced with BioNTech and Novavax to provide manufacturing services for their respective COVID-19 vaccines.
Strengthened its European and global pharmaceuticals portfolio through strategic rights acquisitions in line with the company’s strategy to bolster its pharmaceuticals business and expand its presence globally in specialty pharmaceuticals:
The company acquired rights to specified territories outside of the U.S. to the widely prescribed chemotherapy medication Caelyx, known as Doxil in several geographies, including the U.S.; this supplements Baxter’s U.S. rights to Doxil, acquired in 2019.
Baxter also acquired full U.S. and specified OUS rights to the anti-nausea medication Transderm Scop, representing a key adjacency to Baxter’s industry-leading inhaled anesthetics portfolio; Baxter previously had a license to sell the product to select customers in the U.S.
Corporate Responsibility

Baxter is fully committed to promoting the power of diversity in support of its Mission. The company’s multidimensional ACT (Activating Change Today) initiative is focused on advancing racial justice for our employees, external stakeholders, and the markets and communities Baxter serves. Among recent highlights, Baxter:

Announced a new partnership with the American Diabetes Association (ADA) through the ADA’s Health Equity Now platform to address health disparities for people with diabetes in Chicago’s underserved Black communities. The program is made possible through a three-year, $2 million grant from the Baxter International Foundation.
Launched a new Baxter-supported partnership with The Links, Incorporated, an international not-for-profit comprised of 16,000 women of color, to advance a multifaceted, community-based campaign to bring awareness and resources to help address the disproportionate challenges affecting Black Americans related to kidney health. Central to this effort is an educational toolkit developed by The National Kidney Foundation of Illinois focusing on the unique barriers facing the Black community.
Baxter continues to be recognized for its commitment to corporate social responsibility and workplace excellence. The company was most recently:

Cited by Forbes as one of America’s Best Employers for Diversity 2021.
Recognized on Seramount’s inaugural Global Inclusion Index for the strength of local diversity, equality, and inclusion (DE&I) efforts in Brazil, China, France, Germany, India, Ireland, Italy, Japan, Mexico, Singapore, and the United Kingdom. All Baxter geographies participating in the assessment earned recognition.
2021 Financial Outlook

For full-year 2021: Baxter now expects U.S. GAAP earnings of $2.85 to $2.93 per diluted share and adjusted earnings, before special items, of $3.47 to $3.55 per diluted share. The company expects sales growth of 8% to 9% on a reported basis, 5% to 6% on a constant currency basis and 4% to 5% on an operational basis.

For second-quarter 2021: The company expects sales growth of 14% to 15% on a reported basis, 8% to 9% on a constant currency basis and 7% to 8% on an operational basis. The company expects U.S. GAAP earnings of $0.54 to $0.57 per diluted share and adjusted earnings, before special items, of $0.72 to $0.75 per diluted share.

Full-year and quarterly operational sales estimates for 2021 have been adjusted to exclude the impact of foreign exchange and the acquisition of specified OUS rights to Caelyx/Doxil.

A webcast of Baxter’s first-quarter 2021 conference call for investors can be accessed live from a link on the company’s website at www.baxter.com beginning at 7:30 a.m. CDT on April 29, 2021. Please see www.baxter.com for more information regarding this and future investor events and webcasts.

About Baxter

Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.

Non-GAAP Financial Measures

This press release and the accompanying tables contain financial measures that are not calculated in accordance with U.S. GAAP. The non-GAAP financial measures include adjusted gross margin, adjusted selling, general and administrative expense, adjusted research and development expense, adjusted other operating income, net, adjusted operating income, adjusted operating margin, adjusted income before income taxes, adjusted income tax expense, adjusted net income, adjusted net income attributable to Baxter stockholders, and adjusted diluted earnings per share, all of which exclude special items, sales growth on a constant currency and operational basis, and free cash flow. Special items are excluded because they are highly variable or unusual, and of a size that may substantially affect the company’s reported operations for a period. Certain of those items represent estimates based on information reasonably available at the time of the press release. Future events or new information may result in different actual results.

Net sales growth rates are presented on a constant currency basis. These measures provide information on the percentage change in net sales growth assuming that foreign currency exchange rates have not changed between the prior and current periods. Net sales growth rates are also presented on an operational basis. For the quarter ended March 31, 2021, operational sales growth excludes the impact of foreign exchange and the company’s recent acquisition of specified OUS rights to Caelyx/Doxil. This measure provides information on the change in net sales growth rates assuming that foreign exchange rates remain constant and excluding the impact of the company’s recent acquisition of specified OUS rights to Caelyx/Doxil.

For the quarter ended March 31, 2021, special items include intangible asset amortization, business optimization charges, acquisition and integration expenses, expenses related to European medical devices regulation and investigation and related costs. These items are excluded because they are highly variable or unusual and of a size that may substantially impact the company’s reported operations for a period. Additionally, intangible asset amortization is excluded as a special item to facilitate an evaluation of current and past operating performance and is consistent with how management and the company’s Board of Directors assess performance.

Non-GAAP financial measures may enhance an understanding of the company’s operations and may facilitate an analysis of those operations, particularly in evaluating performance from one period to another. Management believes that non-GAAP financial measures, when used in conjunction with the results presented in accordance with U.S. GAAP and the reconciliations to corresponding U.S. GAAP financial measures, may enhance an investor’s overall understanding of the company’s past financial performance and prospects for the future. Accordingly, management uses these non-GAAP measures internally in financial planning, to monitor business unit performance, and, in some cases, for purposes of determining incentive compensation. This information should be considered in addition to, and not as substitutes for, information prepared in accordance with U.S. GAAP.

On April 29, 2021 Orexo reported that Q1 2021 Interim Report (Press release, Orexo, APR 29, 2021, View Source [SID1234578849])

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Q1 2021 summary

Total net revenues of SEK 132.3 m (175.0)
Net earnings of SEK -31.5 m (82.6)
EBITDA of SEK -23.9 m (39.1)
US Pharma segment (ZUBSOLV US) net revenues of SEK 126.8 m (163.9), EBIT of SEK 66.1 m (75.9)
Cash flow from operating activities of SEK -47.8 m (48.1), cash balance of SEK 725.5 m (861.4)
A new patent for OX124, overdose rescue medication, was issued by the US Patent and Trademark Office (USPTO), protecting the technology until 2039
Issued a new corporate bond amounting to a nominal value of SEK 500 m and redemption of the corporate bond issued in 2017
A partnership agreement was reached with Magellan Rx, the third largest payor for treatment of opioid dependence in the US, to test modia with patients and other payors in their network
A new patent for ZUBSOLV, with protection until 2032, was issued by the USPTO

ZUBSOLV demand will contribute to a solid foundation for future growth
During the first quarter of 2021, we made good progress on multiple fronts. I am pleased to see that ZUBSOLV demand has stabilized compared to the previous quarter, alongside the refinancing of the corporate bond, which has further strengthened Orexo´s opportunity to grow. Within our innovative digital therapeutic venture, several important steps have been taken to encourage growth in this new market and for our sales to start gaining momentum. As US society is moving to post-pandemic conditions, access to our customers is also increasing. This will be an important driver for ZUBSOLV to return to growth and for the launch of our clinically proven digital therapies.

ZUBSOLV – continued strong EBIT contribution from US Pharma
We have seen a decline in ZUBSOLV net sales in Q1 as expected, following the seasonal patterns for Q1 seen since the launch of the product. This year we have fewer shipping days in Q1 compared to Q4, leading to an overall decline in the market despite a positive weekly trend. For ZUBSOLV, wholesalers and pharmacies traditionally build inventory in Q4 in anticipation of price increases in January. Patients in the commercial payer segment also have their co-pay reset at the start of a new calendar year, which leads to a slow down in this part of the market. Overall, I have been pleased to see the weekly demand, i.e. prescriptions of ZUBSOLV, stabilizing over the quarter,¹ and in particular to see a couple percent growth in weekly prescriptions in the Open segment, despite the difficulties for our sales representatives to access their customers due to Covid-19.
I am also proud we have maintained a strong EBIT contribution of 52 percent in the quarter, which should be seen in light of increased legal expenses. A stable sales and EBIT contribution from ZUBSOLV, together with the refinancing of the corporate bond, enable us to invest in establishing Orexo as a leading player in digital health, without impacting the development of our pharmaceutical pipeline.

Digital therapeutics – a high-potential market in its infancy
We have made important progress over the quarter to expand the market for digital therapeutics. We signed an agreement with Magellan Rx, one of the largest Pharmacy Benefit Managers (PBMs) in the US, to conduct a real world evidence study with modia, to demonstrate its potential as a valuable treatment option in opioid use disorder. modia was the reason we entered digital therapies and we continue to see significant value in the combination with primarily ZUBSOLV, but also other buprenorphine products for patients, physicians and payers, such as Magellan Rx. We have also initiated a pilot of vorvida and deprexis with a leading US tech company, and two larger healthcare providers are preparing an integration of vorvida and deprexis into their treatment programs during Q2. The latter are leveraging a similar insurance pathway as the one Orexo recently tested with vorvida in Pennsylvania. The test in Pennsylvania will now expand into new geographies and the insurance pathway will be the basis of the launch of deprexis to health care providers which has started in April.

Despite the obvious patient need for these ground-breaking treatments, the implementation of digital therapies takes time and we need more awareness and evidence for the therapies before we can expect the market to accelerate. We are therefore focusing our efforts on setting up pilots and trials with well known health care providers, employers and payers to receive their endorsements and recommendations. So far I am encouraged by the positive feedback we are receiving and in particular their compliments to the products when comparing to other digital therapies they have assessed and look forward seeing this translate into a revenue contribution as the pilots transform into commercial contracts.

OX124 – urgent need for new treatment of opioid overdose
New preliminary yearly data2 from Center of Disease Control indicates an increase in overdoses by
27 percent, where the portion caused by synthetic opioids, such as fentanyl, rose by 49 percent. Thus the need for our most advanced development project, OX124, a rescue medication for opioid overdose, is increasing everyday. We continue to make good progress towards initiating the final clinical study according to plan in late Q2. In parallel, minor adjustments were made to build up the supply chain in preparation to launch in the US market in 2023. With the differentiation shown in the first clinical study, versus the leading product on the market, we are confident the commercial potential for the product in the US is substantial.

Summary and outlook
Social responsibility in the pharmaceutical industry is becoming increasingly important, especially in the wake of Covid-19. The number of people suffering from mental illness and substance use disorders is growing rapidly. Orexo’s ongoing transformation journey, from a one-product company to a company offering both pharmaceuticals and clinically proven digital therapies, means that we will be able to help many more people in urgent need of help. This mission is fully embraced by my excellent staff in both Sweden and the US, and is underpinned by our solid financial position.

Presentation
At 2.00 pm CET, the same day as the announcement of the report, Orexo invites analysts, investors and media to
attend a presentation where Nikolaj Sørensen, CEO and Joseph DeFeo, CFO, will present the report and host a Q&A.
Questions can also be sent in advance to [email protected] , no later than 11.00 am CET.
Please view the instructions below on how to participate.
Internet: View Source
Telephone: SE + 46 8 505 583 56 UK + 44 333 300 92 61 US + 1 833 823 05 90
The presentation material will be available on Orexo´s website prior to the audiocast, view Investors/Reports, presentations and audicasts

This information is information that Orexo AB (publ.) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 8.00 am CET on April 29, 2021.

Evelo Biosciences has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Evelo Biosciences, 2021, NOV 5, 2019, View Source [SID1234578723]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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