On October 20, 2021 Abbott (NYSE: ABT) reported that financial results for the third quarter ended Sept. 30, 2021 (Press release, Abbott, OCT 20, 2021, View Source [SID1234591576]).

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Third-quarter sales of $10.9 billion increased 23.4 percent on a reported basis and 22.4 percent on an organic basis, which excludes the impact of foreign exchange.
Third-quarter GAAP diluted EPS was $1.17 and adjusted diluted EPS, which excludes specified items, was $1.40, reflecting 42.9 percent growth versus the prior year.1
Abbott projects full-year 2021 diluted EPS from continuing operations on a GAAP basis of $3.55 to $3.65 and full-year adjusted diluted EPS from continuing operations of $5.00 to $5.10, reflecting growth of 38.4 percent at the mid-point versus prior year.2
In August, Abbott announced U.S. FDA approval of its Amplatzer Amulet device, which offers immediate closure of the left atrial appendage – an area in the heart where blood clots can form.
In August, Abbott announced results of the company’s GUIDE-HF clinical trial, which showed Abbott’s CardioMEMS remote monitoring system can improve care for more patients living with heart failure. Abbott filed a Premarket Approval (PMA) supplement with the FDA for consideration of an expanded indication for CardioMEMS.
In September, Abbott announced U.S. FDA approval of its Portico with FlexNav transcatheter aortic valve replacement (TAVR) system to treat people with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery.
During the third quarter, Abbott acquired Walk Vascular, LLC, a commercial-stage medical device company with a minimally invasive thrombectomy system designed to remove peripheral blood clots.
"We achieved another quarter of strong growth overall and across all four of our major business areas," said Robert B. Ford, president and chief executive officer, Abbott. "We’re particularly pleased with the continued advancements of our new product pipeline, including several recent launches in large, high-growth markets."

THIRD-QUARTER BUSINESS OVERVIEW
Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business. Organic sales growth excludes the impact of foreign exchange.

Following are sales by business segment and commentary for the third quarter 2021:

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average
foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Third-quarter 2021 worldwide sales of $10.9 billion increased 23.4 percent on a reported basis and 22.4 percent on an organic basis.

Compared to pre-pandemic sales in 2019, worldwide sales, excluding COVID-19 testing-related sales3, increased 11.7 percent on both a reported and organic basis in the third quarter.

Worldwide Nutrition sales increased 9.6 percent on a reported basis and 8.9 percent on an organic basis in the third quarter. Strong performance of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes nutrition brand, led to global Adult Nutrition sales growth of 9.8 percent on a reported basis and 9.3 percent on an organic basis.

Worldwide Pediatric Nutrition sales increased 9.4 percent on a reported basis and 8.6 percent on an organic basis. Strong performance of Abbott’s market-leading oral hydration brand, Pedialyte, and continued share growth in infant nutrition led to U.S. Pediatric Nutrition growth of 20.2 percent.

Worldwide Diagnostics sales increased 48.2 percent on a reported basis in the third quarter and increased 46.8 percent on an organic basis. Global COVID-19 testing-related sales were $1.9 billion in the third quarter, led by combined sales of $1.6 billion from Abbott’s BinaxNOW, Panbio and ID NOW rapid testing platforms. Excluding COVID-19 testing-related sales, worldwide diagnostics sales increased 14.1 percent on a reported basis in the third quarter and 12.5 percent on an organic basis.4

Compared to the pre-pandemic 2019 baseline, sales in Core Laboratory and Molecular Diagnostics, excluding COVID-19 testing-related sales, grew 5.8 percent and 14.9 percent, respectively, on a reported basis in the third quarter and grew 4.9 percent and 13.6 percent, respectively, on an organic basis.5

Established Pharmaceuticals sales increased 15.1 percent on a reported basis in the third quarter and increased 15.3 percent on an organic basis.

Key Emerging Markets include India, Brazil, Russia and China along with several additional emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies increased 17.1 percent on a reported basis in the quarter and increased 17.9 percent on an organic basis. Organic sales growth was led by strong growth across several geographies, including China, Russia and India.

Other sales increased 9.7 percent on a reported basis in the quarter and increased 8.5 percent on an organic basis.

Worldwide Medical Devices sales increased 14.6 percent on a reported basis in the third quarter and increased 13.1 percent on an organic basis. Strong growth in the quarter was driven by continued recovery from the COVID-19 pandemic and strong growth in Diabetes Care.

Compared to pre-pandemic sales in 2019, Medical Devices sales increased 18.5 percent on a reported basis and 16.1 percent on an organic basis in the third quarter, led by double-digit growth in Electrophysiology, Heart Failure, Structural Heart and Diabetes Care.6

In Diabetes Care, FreeStyle Libre and Libre Sense sales were $968 million in the quarter, which represents sales growth of 41.6 percent on a reported basis and 38.8 percent on an organic basis.

During the quarter, Abbott continued to strengthen its Medical Devices portfolio with several new products, including:

U.S. FDA approval of Amplatzer Amulet Left Atrial Appendage Occluder to treat people with atrial fibrillation who are at risk of ischemic stroke.
U.S. FDA approval of Portico with FlexNav transcatheter aortic valve replacement (TAVR) system to treat people with symptomatic, severe aortic stenosis who are at high risk for open-heart surgery.
U.S. FDA approval of Amplatzer Talisman PFO Occlusion System to treat people with a patent foramen ovale – a small opening between the upper chambers of the heart – who are at risk of recurrent ischemic stroke.
Abbott acquired Walk Vascular, LLC, a commercial-stage medical device company with a minimally invasive thrombectomy system designed to remove peripheral blood clots.
ABBOTT’S EARNINGS-PER-SHARE GUIDANCE
Abbott projects 2021 diluted earnings per share from continuing operations under GAAP of $3.55 to $3.65. Abbott forecasts specified items for the full-year 2021 of $1.45 per share primarily related to intangible amortization, restructuring and cost reduction initiatives, including expenses to align its COVID-19 testing-related business with changes during the year in current and projected testing demand, expenses associated with acquisitions and other net expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $5.00 to $5.10 for full-year 2021.

ABBOTT DECLARES 391ST CONSECUTIVE QUARTERLY DIVIDEND
On Sept. 15, 2021, the board of directors of Abbott declared the company’s quarterly dividend of $0.45 per share. Abbott’s cash dividend is payable Nov. 15, 2021 to shareholders of record at the close of business on Oct. 15, 2021.

Abbott has increased its dividend payout for 49 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

On October 20, 2021 Orum Therapeutics, a preclinical biotech pioneering the development of tumor-directed targeted protein degraders to improve cancer treatment, reported that members of its management team will be participating in the SVB Leerink Biopharma Private Company Connect Event (Press release, Orum Therapeutics, OCT 20, 2021, View Source [SID1234591592]). The event will take place virtually October 27-29, 2021.

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On October 20, 2021 The Menarini Group ("Menarini") and Radius Health, Inc. ("Radius") (NASDAQ: RDUS) (collectively, the "Companies") reported positive topline results from the EMERALD study (Press release, Menarini, OCT 20, 2021, View Source [SID1234591612]).

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The study was designed to evaluate elacestrant as a monotherapy versus the standard of care (SoC) for the treatment of ER+/HER2- advanced or metastatic breast cancer (mBC). There were two primary endpoints: progression-free survival (PFS) in the overall population and PFS in patients with tumors harboring Estrogen Receptor 1 (ESR1) mutations.

EMERALD met both primary endpoints, showing statistically significant PFS in the overall population and ESR1 mutation subgroup. The safety profile of elacestrant exhibited in EMERALD was similar to that of the previous clinical trial. Given these results, Menarini and Radius plan on proceeding with regulatory submissions in both the United States and European Union in 2022. In 2018, elacestrant received fast track designation from the FDA.

"We are extremely excited as elacestrant is the first oral SERD to show positive topline results in a pivotal trial as a monotherapy vs SoC for the treatment of ER+HER2-advanced or mBC." commented Elcin Barker Ergun, Chief Executive Officer of the Menarini Group. "The results pave the way towards our working with the regulators to bring elacestrant to patients with ER+/HER2- advanced or metastatic breast cancer, which remains a huge unmet medical need. Notably, the topline results were also positive for the ESR1 mutation sub segment, an important driver of resistance to endocrine therapy in ER+/HER2- mBC patients. We intend to share the data at the San Antonio Breast Cancer Symposium in December."

Elacestrant is a selective estrogen receptor degrader (SERD). It was being investigated in the Phase 3 EMERALD trial as a potential once daily, oral treatment, in patients with ER+/ HER2- mBC. Overall, 466 patients were enrolled in the study, including 220 (47%) with tumors harboring an Estrogen Receptor 1 (ESR1) mutation. ESR1 mutations are important drivers for the development of resistance to endocrine therapy in ER+/ HER2- mBC patients.

"Advanced /metastatic ER+/HER2- BC pre-treated with endocrine therapy remains an area of high unmet medical need. Additional therapeutic options for this patient population are urgently needed" said Dr. Aditya Bardia, MD, MPH of the MGH, Associate Professor at the Medicine Department at Harvard Medical School, and Principal Investigator for the EMERALD trial. "The trial results being statistically significant demonstrate a clinically meaningful improvement of PFS in the elacestrant group versus endocrine standard of care in patients previously treated with endocrine therapies and CDK 4/6 inhibitors. The results provide a significant advancement for patients suffering from this devastating disease. It was also important to see the positive data for those patients with ESR1 mutations, known to confer additional resistance to standard endocrine therapy."

Kelly Martin, Radius’ Chief Executive Officer added "completing the EMERALD trial was a tremendous effort given the myriad of Covid related obstacles across the globe. Our collective teams did an outstanding job delivering the results of the trial in a high-quality and, ultimately, successful manner." Martin continued, "the Menarini Group and its leadership team are terrific partners. All of us at Radius look forward to supporting them through US NDA submission".

A full evaluation of the data is ongoing. Current plans are to have those results presented at the upcoming San Antonio Breast Cancer Symposium in December, 2021 and to publish them in a peer-reviewed journal.

About Elacestrant (RAD1901) and EMERALD Phase 3 Study

Elacestrant is a selective estrogen receptor degrader (SERD), out-licensed to Menarini Group, which is being evaluated for potential use as a once daily oral treatment in patients with ER+/ HER2- advanced breast cancer. Studies completed prior to EMERALD indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer. The EMERALD Phase 3 trial is a randomized, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in ER+/HER2- advanced/metastatic breast cancer patients. The study has enrolled 466 patients who have received prior treatment with one or two lines of endocrine therapy, including a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients in the study were randomized to receive either elacestrant or the investigator’s choice of an approved hormonal agent. The primary endpoint of the study is progression-free survival (PFS) in the overall patient population and in patients with estrogen receptor 1 gene (ESR1) mutations. Secondary endpoints include evaluation of overall survival (OS), objective response rate (ORR), and duration of response (DOR).

On October 20, 2021 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that it has entered into a collaboration agreement with Ab Magnitude Ventures Group, LLC and Ab Magnitude Fund, LP (collectively, "Ab Magnitude") for the development of next-generation targeted oncology therapeutics (Press release, SpringWorks Therapeutics, OCT 20, 2021, View Source [SID1234591821]). Ab Magnitude is led by Yibing Shan, Ph.D., a leading structural computational biologist who was a founding member of D.E. Shaw Research, a pioneering computational biochemistry research company. Dr. Shan’s simulations of protein structural dynamics have previously yielded important insights on the activity of key oncogenic proteins and the identification of novel binding sites suitable for small molecule therapies. SpringWorks and Ab Magnitude will collaborate on target discovery and initial hit finding to advance next generation oncology therapeutics. In addition, the parties will also collaborate on a portfolio of novel EGFR inhibitors recently in-licensed by SpringWorks from the Dana-Farber Cancer Institute with Ab Magnitude supporting optimization and characterization of the portfolio using its computational platform.

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"We believe that Dr. Shan’s track record of identifying novel druggable targets for the design of new cancer therapies is unparalleled and represents a natural complement to our strategy of developing differentiated targeted therapies on behalf of cancer patients," said Badreddin Edris, Ph.D., Chief Operating Officer of SpringWorks. "We look forward to collaborating with Ab Magnitude and we believe that by incorporating these cutting-edge computational approaches into our early-stage drug discovery and development capabilities, we will be well positioned to continue expanding our emerging preclinical pipeline and advancing promising candidates into the clinic."

"I am excited to collaborate with SpringWorks on discovering novel oncology therapeutics using computational molecular and structural modeling approaches and to further optimizing the portfolio of novel EGFR inhibitors that SpringWorks recently in-licensed," said Dr. Shan. "This collaboration has the potential to expedite discovery of novel oncology therapeutics and advancement of promising therapeutic candidates by integrating Ab Magnitude’s computational modeling and target identification expertise with a vertically-integrated biopharmaceutical partner that has the capital resources and expertise to optimize promising candidates to development candidate stage and into clinical studies."

Under the terms of this agreement, Ab Magnitude is eligible for low single-digit percentage royalties on future net sales of products or other realizations of value arising from the collaboration.

On October 20, 2021 Alkermes plc (Nasdaq: ALKS) reported that it will host a conference call and webcast presentation at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, Oct. 27, 2021 to discuss the company’s third quarter 2021 financial results. Management will also provide an update on the company (Press release, Alkermes, OCT 20, 2021, View Source [SID1234591577]).

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The webcast player and accompanying slides may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. A replay of the webcast will be available approximately two hours after the completion of the event and may be accessed by visiting Alkermes’ website.