Press Release: EUROAPI listing on Euronext Paris expected on May 6, 2022

On April 1, 2022 Sanofi reported that the French Autorité des marchés financiers (AMF) has approved the listing prospectus prepared by EUROAPI in connection with the intended listing of its shares on the regulated market of Euronext Paris (Press release, Sanofi, APR 1, 2022, View Source [SID1234611340]).

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On March 17th, 2022, Sanofi’s Board of Directors unanimously decided to submit for approval to its shareholders the proposed distribution in kind (the "Distribution") of EUROAPI shares, via an additional extraordinary dividend, exclusively in kind, in addition to the previously proposed €3.33 cash dividend per Sanofi share. The Distribution relates to circa 58% of the share capital and voting rights of EUROAPI. In connection with the proposed Distribution, EPIC Bpifrance has agreed to purchase 12% of EUROAPI shares1 from Sanofi, which confirmed its intention to hold circa 30% of the share capital and voting rights of the company after the Distribution.

The Distribution by Sanofi to its shareholders of EUROAPI shares in the form of an additional extraordinary dividend, exclusively in kind, is subject to the shareholders’ approval at Sanofi’s May 3, 2022 Ordinary and Extraordinary Shareholders’ Meeting.

Subject to certain customary exceptions, the following lock-up periods have been agreed:

2 years for Sanofi and EPIC Bpifrance following the settlement and delivery of the EUROAPI shares to be sold to EPIC Bpifrance; and
1 year for L’Oréal, Sanofi’s largest shareholder and for Karl Rotthier, CEO of the Company, following the settlement of the Distribution.
Main features of the Distribution are as follows:

The Distribution ratio will be one (1) EUROAPI share per twenty three (23) Sanofi shares.

No fractional EUROAPI shares will be issued. Any right to receive a fractional share will not be tradable or transferable. Consequently, when the amount of the Distribution to which a Sanofi shareholder is entitled does not correspond to a whole number of EUROAPI shares (i.e., less than twenty three (23) or a multiple of twenty three (23) Sanofi shares), the shareholder will receive the immediately lower number of EUROAPI shares, plus a cash payment for the whole of the balance arising from the price at which EUROAPI shares corresponding to fractional shares were sold. Each financial intermediary will sell the shares corresponding to the fractional shares of its entitled clients. As a result, the amount of the cash balance may vary depending on the shareholder’s financial intermediary;

The technical reference price of EUROAPI shares is expected to be announced on May 5, 2022 by Euronext Paris after market close;
The admission to trading of the EUROAPI shares and the ex-date (détachement) of the Distribution will occur at 9.00 am (CET) on May 6, 2022;
The record date (the date on which positions are closed) for Sanofi shares to be eligible to the Distribution is scheduled on May 9, 2022;
Payment of the Distribution (delivery and book-entry of the allocated EUROAPI shares) will take place on May 10, 2022.
Following the Distribution and the purchase of 12% of EUROAPI shares by EPIC Bpifrance, the Sanofi group will no longer control EUROAPI, resulting in a slightly accretive impact on Sanofi 2022 business operating income (BOI) margin2.

Documents related to Sanofi shareholders’ meeting will be made available on April 11, 2022 on the Sanofi dedicated web page.

Investors are invited to read EUROAPI’s press release, issued concurrently and available on EUROAPI’s website announcing the AMF’s approval of its prospectus, and the listing prospectus in order to fully understand the potential risks and rewards associated with any decision to invest in EUROAPI shares. EUROAPI draws attention to the risk factors contained in Chapter 3 and Section 22.2 of the listing prospectus. The occurrence of one or more of these risks may have a significant adverse effect on the business, reputation, financial condition, results of operations or prospects of EUROAPI, as well as on the market price of EUROAPI’s shares.

For information on the tax treatment of the Distribution, shareholders are invited to read Paragraph 22.1.6 of the listing prospectus.

Copies of the French-language listing prospectus, approved by the AMF on March 31, 2022 under number 22-076, are available free of charge and on request from EUROAPI at EUROAPI’s registered office, 15 rue Traversière, 75012 Paris, France, as well as on the websites of the AMF (View Source), Sanofi (View Source) and EUROAPI (listing.euroapi.com). An English-language information document for non-French resident shareholders of Sanofi is also available on Sanofi’s and EUROAPI’s website.

BNP Paribas, BofA Securities Europe SA, and J.P. Morgan SE are acting as Lead ECM Advisors to EUROAPI and Sanofi and Crédit Agricole Corporate and Investment Bank, Deutsche Bank, Natixis SA and Société Générale are acting as Other ECM Advisors in the contemplated listing. Rothschild & Co. is acting as independent financial adviser to Sanofi and EUROAPI. Jones Day is acting as a legal advisor to EUROAPI and Sanofi in connection with the Distribution, and White & Case as legal advisor to the Lead ECM Advisors.

Capital Markets Day details

Today, Sanofi will host a EUROAPI-dedicated Capital Markets Day at 1:30 pm CET and will cover the following topics:

Execution of the Play to Win strategy with the spin-off of EUROAPI
Main features of the Distribution
Sanofi’s long-term commitment to EUROAPI: strong business relationship and future ownership structure alongside with EPIC Bpifrance
EUROAPI’s deconsolidation impact for Sanofi
Presentation of EUROAPI, including its business model, strategy and guidance.

Ferring delivered record results in 2021 and is on course for future ambitions

On April 1, 2022 Ferring reported its latest Annual Report which shows the company reported revenues of €2,162 million, +11% at AER, +14% at CER and a record level of Net Income at €290 million up +91% AER (Press release, Ferring, APR 1, 2022, View Source [SID1234611339]). These results reflect the company’s strong and leading position in the field of reproductive medicine and maternal health (RMMH), and its growing presence in other specialty areas of medicine. Ferring sales rebounded strongly following the various impacts of COVID-19 during 2020, most particularly within the RMMH franchise in the United States.

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Sales within RMMH grew at 27% CER and achieved a CAGR over the last 2 years of 11% per year driven by our flagship product Menopur, used in ovarian stimulation for women undergoing assisted reproductive technologies. Sales growth within our other specialty franchises in gastroenterology and urology was more muted with some strong individual product performances somewhat offset by product discontinuations and divestments.

Through sustained focus and initiatives on operational efficiency in recent years, increase in operating expenses was constrained to 2% CER benefiting from increased focus and disciplined allocation of resources. Throughout the year important investments were made in protecting our manufacturing infrastructure and the wider supply chain from the volatility caused by COVID-19.

In line with our strategic ambitions, Ferring continued to prioritise investment in progressing our late-stage opportunities and our mid-term growth opportunities which are critical to our future success and achieved many key regulatory milestones during the year.

The combination of strong sales growth and constrained increase in the cost base resulted a significant increase in operating profit growth of 70% CER to reach €358 million. This improved operating profit drove an increase in net cash flow from operations of 38% AER to reach €450 million, and the company maintains its solid financial base from which to realise its strategic agenda over the next years.

"Despite many challenges, 2021 proved to be a year of remarkable progress for Ferring, and we ended the year in a stronger financial position than ever before", said Dominic Moorhead, Chief Financial Officer at Ferring.

The President of Ferring, Per Falk, also commented "2021 was a record year for the company and we are well poised to deliver on the next phase of our growth agenda as we aim to help people live better lives".

CER – Constant Exchange Rates, which exclude any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period
AER – Actual Exchange Rates
CAGR – Compound Annual Growth Rate

Alligator Bioscience Announces Completion of 600 mg Dose Cohort for ATOR-1017, Dose-escalation and Enrollment for 900 mg dose Cohort Commences

On April 1, 2022 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported the completion of the patient enrollment for the 600 mg dose cohort from Alligator’s Phase I, first-in-human clinical trial with the 4-1BB (CD137) targeting drug candidate, ATOR-1017, which is being developed as a tumor-directed therapy for advanced/metastatic cancer (Press release, Alligator Bioscience, APR 1, 2022, https://alligatorbioscience.se/en/alligator-bioscience-announces-completion-of-600-mg-dose-cohort-for-ator-1017-dose-escalation-and-enrollment-for-900-mg-dose-cohort-commences/ [SID1234611338]). The Phase I study with ATOR-1017 is an open-label, dose escalation study in patients with histologically confirmed, advanced and/or refractory solid cancer (NCT04144842). The primary objective of the study is to investigate the safety and tolerability of ATOR-1017, and to determine the recommended dose for subsequent Phase II studies.

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The data indicate that for doses up to 600 mg, there were no significant safety concerns with stable disease as the best tumor response. Patient enrollment and treatment for the highest planned dose cohort, 900 mg, has commenced.

As previously announced in December 2021, results from the early readout for ATOR-1017 showed that the drug candidate has an encouraging safety profile. In this readout, there was no dose-limiting toxicity or severe immune-related adverse events (link to press release).

Artios attending the AACR in New Orleans 8-12 April 2022

On April 1, 2022 Artios reported that it will be attending the AACR (Free AACR Whitepaper) in New Orleans from 8 – 12 April (Press release, Artios Pharma, APR 1, 2022, View Source [SID1234611337]). If you wish to meet with the team, please contact Stacy at [email protected]

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Attending will be Niall Martin, (CEO), Abid Ansari (CFO), Tania Dimitrova (CBO) Graeme Smith (CSO) and Jay Majithiya (SP Scientist).

Y-mAbs Announces Submission of Omburtamab Biologics License Application to FDA

On April 1, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that on March 31, 2022, the Company completed the resubmission of its Biologics License Application ("BLA") for 131I-omburtamab ("omburtamab") to the FDA (Press release, Y-mAbs Therapeutics, APR 1, 2022, View Source [SID1234611336]).

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Omburtamab is an investigational, monoclonal antibody that targets B7-H3, an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types. The omburtamab BLA is for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. The submission is based on the safety and efficacy results of the pivotal Phase 2 studies 101 and 03-133, which the Company expects to publish later this year.

"I am excited to see the completion of Y-mAbs’ second BLA submission in neuroblastoma. As children treated for high-risk systemic neuroblastoma potentially experience longer systemic remissions, we expect more patients eventually relapsing with brain metastasis and there is currently no effective therapy beyond surgery and radiotherapy available for these patients." stated Thomas Gad, Founder, Chairman and President. "As the father of a long-term high-risk neuroblastoma survivor, treated with a predecessor to DANYELZA for systemic high-risk neuroblastoma, and when relapsing with CNS/leptomeningeal metastasis, treated with omburtamab, I know how important this potentially is for families faced with brain metastasis from high-risk neuroblastoma. Y-mAbs was initially founded with the goal of potentially getting both these drugs approved in order to make a major impact on families all over the world."

Dr. Claus Moller, Chief Executive Officer, continued, "We believe omburtamab can potentially address a significant unmet medical need for children with CNS/leptomeningeal metastasis from neuroblastoma, and we look forward to working with the FDA to bring omburtamab to the appropriate patients. This is a key milestone for families and patients facing CNS/leptomeningeal metastasis from neuroblastoma and for Y-mAbs."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests related to the compound.