On February 22, 2022 Sumitomo Dainippon Pharma Oncology, Inc., a clinical-stage pharmaceutical company focused on research and development for novel cancer therapeutics, reported the appointment of Jatin J. Shah, M.D. as Executive Vice President, Chief Medical Officer and Global Head of Development (Press release, Sumitomo Dainippon Pharma, FEB 22, 2022, View Source [SID1234608844]). In this new position Dr. Shah will lead strategic and operational clinical development of the company’s diverse pipeline.

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"Dr. Shah brings significant industry and clinical oncology experience, which is well-aligned with our future growth and success priorities," said Patricia S. Andrews, Chief Executive Officer, Global Head of Oncology, Sumitomo Dainippon Pharma Oncology (SDP Oncology). "We are pleased to have such an accomplished physician and researcher join us in our mission to discover and develop meaningful treatments for patients with cancer."

Dr. Shah brings over 20 years of medical and industry experience to SDP Oncology. Most recently, he served as Chief Medical Officer and Executive Vice President at Karyopharm Therapeutics where he led clinical research efforts that resulted in three successful sNDAs, multiple IND submissions and the development of a comprehensive solid tumor and hematological pipeline. At the University of Texas MD Anderson Cancer Center, Dr. Shah was an Associate Professor and Associate Program Director of the Malignant Hematology Fellowship, as well as Director of Myeloma Clinical and Translational Research in the Department of Lymphoma/Myeloma, Division of Cancer Medicine.

"I am excited to join the talented team at SDP Oncology and work with researchers and scientists who share a commitment to patients with cancer," said Jatin J. Shah, M.D. "I look forward to contributing to the next phase of SDP Oncology’s growth as we work to address unmet needs in oncology and advance the development of our clinical and pre-clinical assets."

Dr. Shah received his undergraduate degree in Mechanical Engineering from Ohio State University and earned his medical degree from the Ohio State University College of Medicine. He completed an internship and residency in internal medicine at the Cleveland Clinic Foundation and a fellowship in hematology/oncology at the University of Alabama at Birmingham.

On February 22, 2022 Medtronic plc (NYSE: MDT), a global leader in healthcare technology, and the American Society for Gastrointestinal Endoscopy (ASGE) reported they are working to provide colorectal cancer screening technologies in low income and underserved communities across the United States through the Medtronic Health Equity Assistance Program for colon cancer screening, with support from Amazon Web Services (AWS) (Press release, Medtronic, FEB 22, 2022, View Source [SID1234608842]). The initiative will include the donation of 50 Medtronic GI Genius intelligent endoscopy modules to endoscopy centers across the country that can potentially improve the detection of polyps that can lead to colorectal cancer. Certain types of colorectal cancer, when caught early, can have a survival rate (five year) of up to 91%; however, it remains the third most common and third deadliest cancer among adults in the United States. With these placements, there is an opportunity to potentially impact more than 350,000 patients over three years.

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The goal of this program is to increase early detection and diagnosis in underserved communities.

"Addressing gaps in colorectal cancer screening is complex. We know that Black adults are more likely to be diagnosed and subsequently die from this disease. There are also disparities in screenings among different groups, including adults in rural communities," said Douglas K. Rex, M.D., MASGE, president, ASGE. "Colonoscopy is critical in preventing colorectal cancer and as the global leader in gastrointestinal endoscopy, ASGE is working together with Medtronic to ensure that providers receive screening technology and are able to use them in communities where they are most needed."

AWS has provided computing credits that have made the funding of this program possible and continues to work with Medtronic to support the ongoing development of GI Genius and innovative future Medtronic health screening technologies that will further support Medtronic’s health equity efforts. ASGE is independently leading the application and selection process to determine the facilities that otherwise would be unable to fund this innovative solution for underserved patient populations. Initial recipients will be announced in March 2022 during Colorectal Cancer Awareness Month.

"The crisis of health inequities cannot be solved without expanding access to healthcare technologies that put people first," said Geoff Martha, Medtronic chairman and chief executive officer. "We must begin with local efforts that consider the needs of the community. This program is an important step towards ensuring that our powerful technologies help reduce disparities, improve care and enhance patient outcomes."

The GI Genius intelligent endoscopy module, authorized by the FDA in April 2021, detects colorectal polyps of varying shapes and sizes automatically in real time which helps diagnose and prevent colorectal cancer. It is the first-to-market, computer-aided polyp detection system powered by artificial intelligence (AI) that provides physicians with a powerful solution in the fight to screen, detect and prevent colorectal cancer and an increase of up to 14.4% absolute detection rate (ADR). Each 1% increase in ADR decreases patients’ risk of colorectal cancer by 3%.

Earlier this month, Medtronic released its Global Inclusion, Diversity and Equity Annual Report, which maps out the Company’s Zero Barriers commitment to remove barriers to opportunity — including efforts to improve access to healthcare technology. As part of this work, Medtronic introduced several initiatives in 2021 to reduce health inequities among people of color living with diabetes, including supporting the American Diabetes Association’s Technology Access Project.

"This effort is part of Medtronic’s Zero Barriers approach to building equity within our healthcare system, accelerating our innovation and helping to bring our lifesaving technologies to more patients," said Giovanni Di Napoli, president of the Medtronic Gastrointestinal business, which is part of the Medical Surgical Portfolio at Medtronic. "The program represents a continuation of Medtronic’s commitment to health equity anchored in healthcare technology."

"Individual health outcomes should not depend on socioeconomic status, race, ethnicity, or neighborhood," said Maggie Carter, global lead for social impact at AWS. "We are pleased to support Medtronic and ASGE as part of AWS’s recently launched health equity program to help these organizations bring effective screening tools to the communities that need them most."

For more information and to apply, visit: ASGE’s program website.

About ASGE
Since its founding in 1941, the American Society for Gastrointestinal Endoscopy (ASGE) has been dedicated to advancing patient care and digestive health by promoting excellence and innovation in gastrointestinal endoscopy. ASGE, with almost 15,000 members worldwide, promotes the highest standards for endoscopic training and practice, fosters endoscopic research, recognizes distinguished contributions to endoscopy, and is the foremost resource for endoscopic education. Visit Asge.org and ValueOfColonoscopy.org for more information.

On February 22, 2022 GT Medical Technologies Inc., reported that creators of GammaTile Therapy, a Surgically Targeted Radiation Treatment for operable brain tumors, reported its 2021 roster of ELITE Distinguished Brain Tumor Specialists that have completed 10 or more GammaTile Therapy procedures in 2021 (Press release, GT Medical Technologies, FEB 22, 2022, View Source [SID1234608841]). This year’s introduction into the ELITE program includes Piedmont Atlanta Hospital, Vidant Medical Center, Emory Healthcare, and The University of Kansas Health System. These hospitals join the existing ELITE Distinguished Brain Tumor specialists awarded in 2020, including Memorial Sloan Kettering Cancer Center, M Health Fairview, HonorHealth Scottsdale Osborn Medical Center, NorthShore University HealthSystem, and Mayfield Brain & Spine.

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GammaTile ELITE institutions share GT Medical Technologies’ purpose of improving the lives of patients with brain tumors. These medical centers are each committed to excellence by putting quality of life for their patients first and embracing evidence-based innovation.

"GammaTile represents a major upgrade compared to standard radiotherapy options," said Roukoz Chamoun, MD, Neurosurgeon and Associate Professor, Department of Neurosurgery, The University of Kansas Health System in Kansas City, KS. "With GammaTile, radiation is delivered precisely where it is needed resulting in increased efficacy and minimal potential for side effects. In addition, because it is placed during surgery immediately after tumor resection, it eliminates unnecessary and potentially dangerous delay in radiation therapy."

"GammaTile allows us to treat previously untreatable patients and has allowed selected patients to achieve astonishing survival durations. At Piedmont we love having this tool in our toolbox," said Adam Nowlan, MD, MPH, Medical Director, Radiation Oncology, Piedmont Atlanta Hospital in Georgia.

GammaTile Therapy features a bioresorbable, conformable, 3D-collagen tile that is implanted in the last five minutes of brain tumor removal surgery. The sustained, controlled, and therapeutic dose of radiation immediately begins targeting tumor cells, sparing healthy tissue. Patients receive their radiation treatment while going about their daily life, without the necessity of daily trips to a medical center for external radiation. Over time, the tile naturally resorbs into the adjacent tissue with no need for additional surgery to remove it. GammaTile Therapy is shown to improve local tumor control, which can extend a patient’s life. GammaTile was FDA-cleared in 2018 for recurrent brain tumors, including recurrent high-grade gliomas, glioblastomas, meningiomas, and brain metastases. In 2020, the FDA expanded that indication to include newly diagnosed malignant brain tumors.

"We are pleased to see this technology become available to patients with brain tumors across the United States, with over 60 leading institutions now offering GammaTile," said Matthew Likens, President & CEO of GT Medical Technologies. "We take great pleasure in welcoming these prestigious institutions into the GammaTile ELITE program and commend them on their commitment to innovation and quality patient care."

GT Medical Technologies was founded by five Arizona brain tumor specialists in 2017 to overcome the limitations of the current standard of care for patients with brain tumors. The treatment has since helped hundreds of patients receive life-altering cancer treatment in top brain tumor centers across the U.S. Healthcare providers can learn more by visiting View Source

On February 22, 2022 Bio-Techne Corporation (NASDAQ: TECH) reported that Jim Hippel, Executive Vice President and Chief Financial Officer, will present at the Citi 2022 Virtual Healthcare Conference on Thursday, February 24, 2022, at 10:15 a.m. EST (Press release, Bio-Techne, FEB 22, 2022, View Source [SID1234608840]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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On February 22, 2022 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported financial results for the fourth quarter and full year ended December 31, 2021, and provided an update on its recent corporate activities and outlook (Press release, Halozyme, FEB 22, 2022, View Source [SID1234608839]).

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"Our performance in the fourth quarter closed out a year of strong performance across our business highlighted by record full year revenue from royalties, growing 130% from last year driven by the continued adoption of our wave 2 partner products subcutaneous DARZALEX and Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf)," said Dr. Helen Torley, president and chief executive officer. "In 2022, we look forward to building on 2021 momentum and anticipate 50% growth in our high-margin, recurring royalty revenues driven by further adoption of wave 2 products. We project further expansion and maturing of our pipeline, with 4 new targets entering Phase 1 development and at least 5 products advancing to Phase 2 or Phase 3 development. We are also excited to be starting development of a higher yield ENHANZE API as well as a new rHuPH20 with extended room temperature stability and patent protection to 2032 in Europe and 2034 in the U.S."

Fourth Quarter Partner Highlights:

In December 2021, Janssen received FDA approval for DARZALEX FASPRO (daratumumab and hyaluronidase – fijh) in combination with Kyprolis (carfilzomib) and dexamethasone for patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.

In December 2021, ViiV initiated enrollment of a Phase 1 study arm to evaluate cabotegravir administered subcutaneously with ENHANZE.

In December 2021, Janssen initiated a Phase 1 clinical trial combining Janssen’s rilpivirine and ENHANZE.

In November 2021, Roche initiated a Phase 1 study combining an undisclosed therapy with ENHANZE for a new exclusive ENHANZE target.

In October 2021, Janssen’s DARZALEX FASPRO was approved by the China National Medical Products Administration for the treatment of primary light chain amyloidosis, in combination with bortezomib, cyclophosphamide and dexamethasone in newly diagnosed patients.

In October 2021, Takeda initiated a Phase 1 single-dose, single-center, open-label, three-arm study to assess the tolerability and safety of immune globulin subcutaneous (human), 20% solution with ENHANZE (TAK-881) at various infusion rates in healthy adult subjects.
Fourth Quarter Corporate Highlights:

In December 2021, the Company announced its second share repurchase program, to repurchase up to $750 million of its outstanding common stock over a three-year period. As part of the new share repurchase program, in December 2021, the Company entered into an accelerated share repurchase agreement to repurchase $150 million of common stock.

In October 2021, the Company repurchased 0.3 million shares of common stock for $10.3 million, completing its initial three-year $550 million share repurchase program that began in November 2019 one year early. Under the program the Company repurchased a total of 22.3 million shares for $550.0 million at an average price per share of $24.72.
Fourth Quarter and Full Year 2021 Financial Highlights

Revenue for the fourth quarter was $102.0 million compared to $121.7 million for the fourth quarter of 2020. The year-over-year decrease was primarily driven by a decrease in revenue under collaboration agreement and product sales, partially offset by an increase in royalty revenue primarily attributable to subcutaneous DARZALEX (daratumumab). Revenue for the quarter included $62.6 million in royalties, an increase of 96% compared to $32.0 million in the prior year period.

Total revenues for the full year were $443.3 million, compared with $267.6 million in 2020, representing growth of 66% year over year.

Cost of product sales for the fourth quarter was $21.6 million, compared to $26.3 million for the fourth quarter of 2020. The year-over-year decrease was primarily driven by lower product sales, principally the sales of bulk rHuPH20 to the Company’s partners.

Cost of product sales for the full year was $81.4 million, compared to $43.4 million in 2020, primarily driven by higher product sales, principally the sales of bulk rHuPH20 to the Company’s partners.

Research and development expenses for the fourth quarter were $10.1 million, compared to $7.4 million for the fourth quarter of 2020. The increase is primarily due to an increase in compensation expense, including stock-based compensation, for personnel to support additional ENHANZE targets entering clinical development.

Research and development expenses for the full year were $35.7 million, compared with $34.2 million in 2020.

Selling, general and administrative expenses for the fourth quarter were $13.8 million, compared to $10.4 million for the fourth quarter of 2020. The increase was primarily due to an increase in compensation expense, including stock-based compensation, for personnel to support additional ENHANZE targets.

Selling, general and administrative expenses for the full year were $50.3 million, compared with $45.7 million in 2020.

Operating Income: On a GAAP basis in the fourth quarter of 2021, operating income was $56.5 million, compared to an operating income of $77.6 million in the fourth quarter of 2020.

Operating income for the full year was $275.9 million, compared to $144.3 million in 2020.

Net Income: On a GAAP basis in the fourth quarter of 2021, net income was $66.8 million, compared with net income of $73.2 million in the fourth quarter of 2020. Non-GAAP net income was $61.3 million in the fourth quarter of 2021, compared with Non-GAAP net income of $80.9 million in the fourth quarter of 2020.1

Net income for the full year on a GAAP basis was $402.7 million or $2.74 per share, compared to a net income of $129.1 million or $0.91 per share in 2020. This year over year comparison is impacted by the one-time tax benefit of $1.05 per share in 2021 as a result of the tax valuation allowance release.

Net income for the full year on a non-GAAP basis was $294.1 million compared with $160.4 million in 2020.

Earnings per Share: On a GAAP basis in the fourth quarter of 2021, diluted earnings per share was $0.46, compared with $0.50 in the fourth quarter of 2020. On a Non-GAAP basis diluted earnings per share was $0.42, compared with diluted earnings per share of $0.56 in the fourth quarter of 2020.1

GAAP diluted earnings per share for the full year was $2.74 compared with $0.91 per share in 2020. These GAAP results included the one-time recognition of a non-cash income tax benefit during 2021 of $1.05 per share. Non-GAAP diluted earnings per share for the full year was $2.00 per share, compared to $1.12 per share in 2020.

Cash, cash equivalents and marketable securities were $740.9 million on December 31, 2021, compared to $368.0 million on December 31, 2020.
Financial Outlook for 2022

The Company is reiterating its financial guidance for 2022 first provided on January 10, 2022. For the full year 2022, the Company expects:

Total revenue of $530 million to $560 million, representing growth of 20%-26% over 2021 total revenue. The Company expects revenue from royalties to increase approximately 50% over revenue from royalties in 2021 to approximately $300 million.

GAAP operating income of $350 million to $380 million, representing growth of 27%-38% over 2021 GAAP operating income, resulting in operating margins greater than 65%.

GAAP net income of $270 million to $295 million; and non-GAAP net income of $290 million to $315 million.1 The Company notes that 2022 will be the first full fiscal year in which Halozyme will record income tax expense as part of its income statement.

Webcast and Conference Call

Halozyme will webcast its Quarterly Update Conference Call for the fourth quarter of 2021 today, Tuesday, February 22, 2022 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme’s corporate website and a replay will be available following the close of the call. To register for this conference call, please use this link: View Source After registering, you will receive an email confirmation that includes dial in details and unique conference call codes for entry. Registration is open through the live call. However, to ensure you are connected for the full call, please register a day in advance or at minimum 10 minutes before the start of the call.