On February 22, 2022 Apollo Endosurgery, Inc. ("Apollo") (Nasdaq: APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, reported financial results for the fourth quarter and year ended December 31, 2021 and corporate highlights (Press release, Apollo Endosurgery, FEB 22, 2022, View Source [SID1234608849]).

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Fourth Quarter and Full Year Financial and Corporate Highlights
•Grew fourth quarter 2021 and full year Endoscopic Suturing System (ESS) revenue 37% and 55% over the same periods in 2020;
•Grew fourth quarter 2021 and full year Intragastric Balloon (IGB) revenue 20% and 50% over the same periods of 2020;
•Increased fourth quarter 2021 and full year revenue from the Company’s top 10 direct accounts by over 50% and 85% over the same periods in 2020;
•Continued X-Tack penetration in key accounts, with fourth quarter 2021 revenue growth of nearly 40% and an increase in ordering customers of nearly 20% compared to the third quarter 2021;
•Secured over $175 million in new capital and borrowing capacity, providing cash runway to fund Apollo’s planned growth initiatives;
•Announced that investigators in the Multi-Center ESG Randomized Interventional (MERIT) study reported that the study met its primary endpoints for safety and efficacy. Patients undergoing the Endoscopic Sleeve Gastroplasty (ESG) achieved excess body weight loss of 49.2% at 12 months and demonstrated improvements in weight-related comorbidities. The MERIT study reported a serious adverse event rate of 2% for patients undergoing the ESG procedure.
•Submitted a De Novo classification request to the U.S. Food and Drug Administration seeking 510(k) classification and clearance for the Apollo ESGTM and Apollo REVISETM devices; and
•Announced the publication of a multi-center study of Apollo’s X-Tack System, demonstrating high success rates, ease of use, and economic value in the treatment of GI defects.
"The fourth quarter capped a transformative year at Apollo, during which we drove increased utilization of our innovative therapeutic endoscopy portfolio, positioned the Company to expand our reach into new indications such as our recent De Novo 510(k) classification request for Apollo ESG and Apollo REVISE, and significantly enhanced our balance sheet to support our growth runway," said Chas McKhann, Apollo’s president and CEO. "We remain focused on long-term value creation, expanding our base of trained physicians, working closely with our customers to drive product utilization, and maximizing the impact of our expanded sales team."

Comparison of Selected GAAP and Non-GAAP Financial Results for Fourth Quarter 2021 to Fourth Quarter 2020
Total worldwide revenue increased to $16.2 million in the fourth quarter of 2021, a 26% increase compared to the fourth quarter of 2020, despite the impact of the recent surge in COVID-19 cases, which pressured procedural volumes in several key geographies, both domestic and international.
ESS product sales increased $2.8 million, or 37% in the fourth quarter of 2021 compared to 2020. Fourth quarter U.S. ESS product sales increased 42% while OUS ESS product sales increased 29%, highlighting continued demand for Apollo’s OverStitch and X-Tack products across a range of patient indications. IGB product sales increased $0.9 million, or 20%, during the fourth quarter 2021 compared to the fourth quarter 2020 reflecting continued strength in demand for the ORBERA balloon. In the U.S., IGB product sales increased 6% while OUS IGB product sales increased 27%.
Gross margin increased by 40 basis points, from 55.9% to 56.3%, and was $9.1 million for the fourth quarter 2021 compared to $7.2 million for the fourth quarter 2020.
Total operating expenses in the fourth quarter were $14.8 million compared to $10.4 million in the fourth quarter 2020. Excluding stock-based compensation, total non-GAAP adjusted operating expenses increased to $13.3 million from $9.8 million in 2020, primarily reflecting increased sales and marketing expenses to support current and anticipated revenue growth.
Loss from operations in the fourth quarter 2021 was $5.7 million compared to $3.2 million in the fourth quarter 2020. Net loss in the fourth quarter of 2021 was $10.4 million compared to $3.5 million in the fourth quarter of 2020, driven largely by an increase in interest expense related to a write-off of deferred financing costs and fees associated with the Company’s debt refinancing in December 2021. Non-GAAP adjusted EBITDA, which excludes stock-based compensation, gain on forgiveness of PPP loan and unrealized foreign exchange was a loss of $3.5 million for the fourth quarter of 2021, compared to a loss of $1.7 million in the fourth quarter 2020.
For more detailed information on non-GAAP calculations, please refer to the tables that follow.
Cash, cash equivalents and restricted cash were $91.8 million as of December 31, 2021, with up to an additional $65.0 million in future draws available under the Company’s credit facility with Innovatus Capital Partners should the Company meet certain revenue milestones.
Current and long-term debt at face value as of December 31, 2021 included $35.0 million outstanding under the Innovatus credit facility and $19.5 million in outstanding convertible notes.
Financial Outlook for 2022
Apollo expects full year 2022 revenue between $73 million and $75 million, representing growth of approximately 16% to 19% over 2021. The Company continues to monitor the potential and uncertain impact of the ongoing COVID-19 pandemic. Should hospitals or outpatient centers, where the company’s procedures are performed, experience continued or additional surges in cases, and need to defer elective procedures to preserve capacity for COVID-19 patients, the company’s ability to achieve these financial projections could be adversely affected.
Resignation of Bruce Robertson from Apollo Board of Directors
Apollo also announced today that Bruce Robertson has retired from the Apollo Board of Directors, effective immediately, to focus on other commitments. Dr. Robertson, Managing Director of H.I.G. Capital, LLC, has served as a member of the Apollo Board of Directors since February 2008.
"Bruce has been instrumental in Apollo’s development in his 14 years of service on our Board," said Chas McKhann. "Personally, he has been a highly valued colleague and advisor in my first year as CEO. We thank Bruce for his unwavering contributions to Apollo’s formation and growth, and we wish him all the best in his future endeavors."
"Since our initial investment in Apollo, my colleagues at H.I.G. Capital and I have been excited about the Company’s potential to play a transformative role in therapeutic endoscopy," said Dr. Robertson, "I leave knowing that Apollo is in good hands under a new leadership team, with a sound strategy to realize the full potential of our original vision."
The Company has engaged Spencer Stuart, a global executive search firm, to lead a search process for Dr. Robertson’s successor.

Conference Call
Apollo will host a live webcast audio call with slides today at 3:30 p.m. CT / 4:30 p.m. ET. Investors are invited to join the live call via webcast from the Investors section of the Company’s corporate website at www.apolloendo.com. An audio-only option is available by dialing +1 973-528-0011 and referencing access code 718442 or the "Apollo Endosurgery Fourth Quarter 2021 Earnings Call." Investors who opt for audio-only will need to download the related slides at www.apolloendo.com.
A replay of the webcast will be made available on Apollo’s website, www.apolloendo.com, shortly after completion of the call.
Non-GAAP Financial Measures
To supplement the Company’s financial statements presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company reports certain non-GAAP financial measures, including non-GAAP adjusted operating expenses and non-GAAP Adjusted EBITDA. Adjusted operating expenses is calculated as operating expense less stock-based compensation. Adjusted EBITDA is calculated as GAAP net loss, plus depreciation and amortization, interest expense, net, income tax expense, stock-based compensation, gain on forgiveness of PPP loan, and unrealized foreign exchange. These supplemental measures of our performance are not required by, and are not determined in accordance with GAAP. The Company believes that these non-GAAP financial measures provide investors with an additional tool for evaluating the Company’s core performance, which management uses in its own evaluation of continuing operating performance, and a baseline for assessing the future earnings potential of the Company. The Company’s non-GAAP financial measures may not provide information that is directly comparable to that provided by other companies in the Company’s industry, as other companies in the industry may calculate non-GAAP financial results differently. Non-GAAP financial results should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. Included in the supplemental tables to this press release is a reconciliation of non-GAAP adjusted EBITDA to GAAP net loss.

On February 22, 2022, Amgen Inc. (the "Company") reported that issued and sold $750,000,000 aggregate principal amount of the Company’s 3.000% Senior Notes due 2029 (the "2029 Notes"), $1,000,000,000 aggregate principal amount of the Company’s 3.350% Senior Notes due 2032 (the "2032 Notes"), $1,000,000,000 aggregate principal amount of the Company’s 4.200% Senior Notes due 2052 (the "2052 Notes"), and $1,250,000,000 aggregate principal amount of the Company’s 4.400% Senior Notes due 2062 (the "2062 Notes" and, together with the 2029 Notes, the 2032 Notes and the 2052 Notes, the "Notes") (Filing, 8-K, Amgen, FEB 22, 2022, View Source [SID1234608848]). The Notes are registered under an effective Registration Statement on Form S-3 (Registration No. 333-236351) (the "Registration Statement"), filed on February 10, 2020, and were issued pursuant to an indenture, dated as of May 22, 2014 (the "Indenture"), between the Company and The Bank of New York Mellon Trust Company, N.A., as trustee, and an officer’s certificate, dated as of February 22, 2022 (the "Officer’s Certificate"), setting forth the terms of the Notes. Net proceeds to the Company from the offering were approximately $3,949,135,700, after deducting underwriters’ discounts and estimated offering expenses payable by the Company.

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The relevant terms of the Notes are set forth in the Indenture, included as Exhibit 4.1 of the Company’s Current Report on Form 8-K, filed on May 22, 2014, and incorporated herein by reference, and the Officer’s Certificate (including the forms of the Notes) attached hereto as Exhibit 4.2 and incorporated herein by reference.

The 2029 Notes will pay interest at the rate of 3.000% per annum, the 2032 Notes will pay interest at the rate of 3.350% per annum, the 2052 Notes will pay interest at the rate of 4.200% per annum and the 2062 Notes will pay interest at the rate of 4.400% per annum, which shall be payable in cash semi-annually in arrears on February 22 and August 22 of each year, beginning on August 22, 2022. The 2029 Notes will mature on February 22, 2029, the 2032 Notes will mature on February 22, 2032, the 2052 Notes will mature on February 22, 2052 and the 2062 Notes will mature on February 22, 2062.

In the event of a change in control triggering event, as defined in the Officer’s Certificate, the holders of the Notes may require the Company to purchase for cash all or a portion of their Notes at a purchase price equal to 101% of the principal amount of Notes, plus accrued and unpaid interest, if any. The descriptions of the Indenture, the Officer’s Certificate and the Notes in this report are summaries and are qualified in their entirety by the terms of the Indenture, the Officer’s Certificate and the Notes, respectively.

The Notes will rank equal in right of payment to all of the Company’s other existing and future senior unsecured indebtedness, senior in right of payment to all of the Company’s existing and future subordinated indebtedness, effectively subordinated in right of payment to all of the Company’s subsidiaries’ obligations (including secured and unsecured obligations) and subordinated in right of payment to the Company’s secured obligations, to the extent of the assets securing such obligations.

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