Alexion to Report First Quarter 2021 Results on Monday, May 3, 2021

On April 20, 2021 Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) reported that the Company will report its financial results for the first quarter ended March 31, 2021 before the US financial markets open on May 3, 2021 (Press release, Alexion, APR 20, 2021, View Source [SID1234578256]).

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Given the previously announced agreement to be acquired by AstraZeneca, Alexion will not be hosting a conference call. Earnings materials will be made available publicly on the Investor Relations page of our website at View Source Questions may be directed to the Investor Relations team via e-mail at [email protected] or the contact information below.

AstraZeneca and Alexion Combination

On December 12, 2020, AstraZeneca and Alexion announced that the companies entered into a definitive agreement for AstraZeneca to acquire Alexion, in which Alexion shareholders will receive $60 in cash and 2.1243 AstraZeneca American Depositary Shares (ADSs) for each Alexion share. Based on AstraZeneca’s reference average ADR price of $54.14 at the time of the announcement, this implied total consideration to Alexion shareholders of $39 billion or $175 per share. The acquisition has the potential to advance the shared science-led mission of both companies to leverage complementary approaches to developing life-changing medicines. The proposed combination will broaden Alexion’s footprint, enabling the company to help more patients, pursue innovative science in new areas and expand its therapies in additional geographies. In addition, the transaction delivers significant value for Alexion’s shareholders, who will have an important stake in the combined company’s future results. Subject to receipt of regulatory clearances and the approval by AstraZeneca and Alexion shareholders, the companies expect the acquisition to close in the third quarter of 2021.

[ALXN-E]

Additional Information and Where to Find It

In connection with AstraZeneca’s proposed acquisition of Alexion (the "proposed transaction"), AstraZeneca filed with the U.S. Securities and Exchange Commission ("SEC") a registration statement on Form F-4 which includes a proxy statement of Alexion and a prospectus of AstraZeneca. The registration statement was declared effective by the SEC on April 12, 2021, and mailing of the definitive joint proxy statement/prospectus to the shareholders of Alexion occurred on or about April 12, 2021. Each of Alexion and AstraZeneca may also file other relevant documents with the SEC regarding the proposed transaction. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE DEFINITIVE JOINT PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain free copies of the registration statement and the definitive proxy statement/prospectus and other documents containing important information about Alexion, AstraZeneca and the proposed transaction through the website maintained by the SEC at View Source Copies of the documents filed with the SEC by Alexion will be available free of charge on Alexion’s website at View Source or by contacting Alexion’s Investor Relations Department by email at [email protected]. Copies of the documents filed with the SEC by AstraZeneca will be available free of charge on AstraZeneca’s website at View Source or by contacting AstraZeneca’s Investor Relations department by email at [email protected].

Participants in the Solicitation

Alexion, AstraZeneca, their respective directors and certain of their executive officers and other employees may be deemed to be participants in the solicitation of proxies from Alexion’s shareholders in connection with the proposed transaction. Information about Alexion’s directors and executive officers is available in Alexion’s proxy statement for its 2020 annual meeting of shareholders, which was filed with the SEC on March 26, 2020, Alexion’s Annual Report on Form 10-K/A for the fiscal year ended December 31, 2020, which was filed with the SEC on February 16, 2021, and other documents subsequently filed by Alexion with the SEC. Information about AstraZeneca’s directors and executive officers is available in AstraZeneca’s Form 20-F filed with the SEC on February 16, 2021, and other documents subsequently filed by AstraZeneca with the SEC. Other information regarding the participants in the proxy solicitations and a description of their direct and indirect interests, by security holdings or otherwise, are contained in the definitive joint proxy statement/prospectus filed with the SEC on April 12, 2021 and other relevant materials to be filed with the SEC regarding the proposed transaction when they become available. Free copies of these documents may be obtained as described in the paragraphs above.

No Offer or Solicitation

This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.

OS Therapies Completes $6 Million Series A Funding Round

On April 20, 2021 OS Therapies, a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat and cure Osteosarcoma (OS) and other deadly cancers in kids and adults including ovarian, esophageal, endometrial and lung cancers, reported the closing of a $6 million Series A round of funding (Press release, OS Therapies, APR 20, 2021, View Source [SID1234578272]).

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The company’s lead product is OST-HER2 targeting Osteosarcoma in kids, which is a listeria cancer vaccine intended to prevent metastasis, increasing overall survival.

"Our primary focus is to get this done: to ensure that this leading technology is employed in a clinical trial, in order to bring new treatments for the deadly disease of Osteosarcoma to market," said Dr. Robert Petit, CMO/CSO of OS Therapies. "The OST-HER2 treatment has been highly successful in multiple trials in canine osteosarcoma, demonstrating 3X improvement in Overall Survival and Disease Progression – we hope to see that it works as well–or even better–in kids."

The completed private placement will also support the advancement of preclinical and toxicology studies for OS Therapies’ second major platform technology OST-TDC: a next generation Drug Conjugate Technology targeting large solid tumors and potentially other diseases. "With the combination of the OST-HER2 late-stage development, and the significant potential of the OST-TDC technology, we believe OS Therapies has found a balanced approach to significant growth potential," said Nathan Cali, Managing Director of Noble Capital Markets.

OS Therapies Executive Chair Colin Goddard, PhD. pointed out: "This funding gives OS Therapies the opportunity to execute on their clinical plan, while opening up funding options for the future corporate structure of what could likely be a fully-integrated biopharmaceutical company."

About Osteosarcoma
Osteosarcoma is a solid tumor of the bone that predominantly occurs in adolescent and young adults (AYA). Standard treatment includes radiation and chemotherapy, with a high recurrence rate and significantly poorer prognosis upon metastasis.

Jazz Pharmaceuticals Announces Proposed Private Offering of Senior Secured Notes

On April 20, 2021 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) (the "Company") reported that its wholly owned subsidiary, Jazz Securities Designated Activity Company (the "Issuer"), is commencing a private offering (the "Offering") of senior secured notes (the "Notes") in a transaction exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), subject to market and other conditions (Press release, Jazz Pharmaceuticals, APR 20, 2021, View Source [SID1234578241]). The Notes will be guaranteed by the Company and certain of the Company’s subsidiaries.

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If the Offering is consummated, the Company expects to use the net proceeds from the Notes and the acquisition date borrowings under new senior secured credit facilities (the "New Senior Secured Credit Facilities"), together with cash on hand to fund the cash consideration payable in connection with the previously announced proposed acquisition of GW Pharmaceuticals plc (the "Acquisition"), the refinancing of certain of the Company’s indebtedness (including the Company’s existing senior secured credit facility) and fees and expenses in connection with the foregoing. The Offering is not conditioned on the closing of the Acquisition. If (1) the Acquisition is consummated without the Company entering into the New Senior Secured Credit Facilities, (2) the Acquisition has not been consummated on or before August 3, 2021 (or such later date to which such date may be extended pursuant to the terms of the Transaction Agreement, dated February 3, 2021, among the Company, GW Pharmaceuticals plc and Jazz Pharmaceuticals UK Holdings Limited (the "Transaction Agreement") or (3) the Transaction Agreement is terminated in accordance with its terms, the Issuer will be required to redeem all of the Notes at a redemption price equal to 100% of their principal amount plus accrued and unpaid interest to, but excluding, the redemption date. There can be no assurance that either the issuance or sale of the Notes or the Acquisition will be consummated.

The Notes will be offered and sold only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act that are located in the United States, Canada, France, Ireland, Luxembourg, the United Kingdom and Bermuda and to certain non-U.S. persons outside the United States pursuant to Regulation S under the Securities Act that are located in Canada, France, Ireland, Luxembourg, the United Kingdom and Bermuda. The Notes have not been registered under the Securities Act or any state securities law and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state laws.

This press release does not constitute an offer to sell or a solicitation of an offer to purchase the Notes or any other securities and does not constitute an offer, solicitation or sale in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful.

JOHNSON & JOHNSON REPORTS 2021 FIRST-QUARTER RESULTS

On April 20, 2021 Johnson & Johnson (NYSE: JNJ) reported results for first-quarter 2021 (Press release, Johnson & Johnson, APR 20, 2021, View Source [SID1234578257]).. "Johnson & Johnson delivered a strong first quarter performance led by the above market growth of our Pharmaceutical business and continued recovery in Medical Devices," said Alex Gorsky, Chairman and Chief Executive Officer "The ability to deliver these results while simultaneously advancing our robust pipeline of life-enhancing medicines, products and solutions during these times is a testament to the strength and resilience of our business and the dedication of the 135,000 employees of Johnson & Johnson who strive every day to profoundly change the trajectory of health for humanity and make healthier communities for everyone, everywhere."

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FIRST-QUARTER 2021 SEGMENT COMMENTARY:

Consumer Health
Consumer Health worldwide operational sales, excluding the net impact of acquisitions and divestitures, declined 2.9%* primarily driven by negative prior year comparisons related to the COVID-19 pantry loading in Q1 2020, mainly in over-the counter products. Partially offsetting the decline is growth in LISTERINE in oral care products, JOHNSON’S BABY in baby care products, international skin health/beauty products and NICORETTE in international over-the-counter products.

Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 7.4%* driven by DARZALEX (daratumumab), for the treatment of multiple myeloma, STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, and for adults with active psoriatic arthritis, INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer. This growth was partially offset by biosimilar and generic competition, with declines primarily in REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, and U.S. ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer.

Medical Devices
Medical Devices worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 8.8%*, and reflects the benefit of market recovery from COVID-19 impacts in the prior year. Contributors to growth were electrophysiology products in the Interventional Solutions business, worldwide biosurgery and energy products, and international endocutters in Advanced Surgery, wound closure products in General Surgery, contact lenses and surgery in the Vision business and trauma products in Orthopaedics; partially offset by knee products in Orthopaedics.

NOTABLE NEW ANNOUNCEMENTS IN THE QUARTER:
The information contained in this section should be read in conjunction with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases available online in the Investors section of the company’s website at news releases.

FULL-YEAR 2021 GUIDANCE:
Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.

Other modeling considerations will be provided on the webcast.

WEBCAST INFORMATION:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investors section of the company’s website at events-and-presentations.

Reify Health Powers Patient Recruitment and Enrollment Across AstraZeneca’s Extensive Breast Cancer Clinical Trial Pipeline

On April 20, 2021 Reify Health reported that AstraZeneca (LSE/STO/Nasdaq: AZN), a leading global biopharmaceutical company, has selected StudyTeam, a patient enrollment management platform, to accelerate clinical development across its breast cancer investigational therapy portfolio (Press release, AstraZeneca, APR 20, 2021, View Source [SID1234578273]). Reify Health’s leading cloud-based solutions connect and empower the clinical trial ecosystem, starting with effective patient recruitment and enrollment. With its use of StudyTeam, AstraZeneca reinforces its reputation as a global sponsor of choice at breast cancer research sites.

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Since 2019, AstraZeneca has deployed Reify Health’s StudyTeam across multiple large global oncology clinical trials. Sites using StudyTeam with AstraZeneca randomize more patients per site per month and provide overwhelmingly positive feedback; in fact, 100% of sites using StudyTeam in its trials choose to do so for subsequent studies. High site engagement, supercharged workflows, and more visibility and control went into AstraZeneca’s decision to expand usage of StudyTeam.

"We now use StudyTeam to track patient recruitment and patient enrollment for all of our studies," said Katherine Wall, senior data manager at clinical research site Redlands Hematology Oncology in Redlands, California. "StudyTeam is a huge game changer for us to track all our patients in the solid tumor and hematologic malignancy trials that we’re participating in, and we’re now able to be even more efficient with our prescreening, thanks to StudyTeam. We’re grateful for sponsors like AstraZeneca that focus on providing sites like ours the solutions we need to enroll effectively."

AstraZeneca will expand use of the StudyTeam platform, including deployment of the Smart Patient Discovery feature. Information from a sponsor’s protocol can now be used to suggest potential patients to any research site coordinator using the StudyTeam system, allowing sites to more effectively connect the right patient to the right trial.

"AstraZeneca is prioritizing the site experience and the patient experience in its breast cancer clinical research program," said Ralph Passarella, CEO and co-founder of Reify Health. "By empowering sites with easy-to-use technology that allows sites to manage patients across all trials, our technology enables AstraZeneca to overcome the traditional challenges of moving candidates effectively through the enrollment funnel. And as the sponsor, AstraZeneca is gaining real-time visibility into patient enrollment to make quick, informed decisions on key issues that reduce site burden, improve candidate identification, and ultimately accelerate enrollment timelines."

AstraZeneca and other top-20 global biopharma companies, including Amgen and Eli Lilly and Company, use Reify Health’s StudyTeam to work with over 3,000 research sites in over 100 countries.