Fosun Pharma Announces 2021 Interim Results

On August 23, 2021 Shanghai Fosun Pharmaceutical (Group) Co., Ltd ("Fosun Pharma" or "the Group"; Stock Code: 600196.SH, 02196.HK), a leading healthcare group in China, reported its interim results for the first half of 2021 ("the Reporting Period") (Press release, Fosun, AUG 23, 2021, View Source [SID1234586856]).

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In the first half of 2021, Fosun Pharma adhered to the implementation of the "4IN" strategy and achieved steady development in the overall business performance. During the Reporting Period, the Group achieved revenue of RMB16,952 million, representing an increase of 20.85% YOY, of which, the income from regions outside Chinese Mainland and overseas countries accounted for 30.66%, marking a step forward on its international operation capability. The net profit attributable to shareholders of the listed company amounted to RMB2,482 million, representing an increase of 44.77% YOY. The net profit attributable to shareholders of the listed company after deducting extraordinary gain or loss amounted to RMB1,570 million, representing an increase of 20.38% YOY.

Innovative products continuously launched with China’s first CAR-T cell therapy approved for marketing

Took innovation and internationalization as its core drivers, as well as increased its R&D investment, through diversified R&D system with independent R&D, cooperative development, license introduction and in-depth incubation, Fosun Pharma accelerated the development of innovative drugs and clinical development, connected with teams of outstanding scientists, leading technologies and high-value products worldwide, to promote the development and transformation of innovative technologies and R&D, based on the overall management of R&D projects by the Global R&D center.

During the Reporting period, Fosun Pharma’s R&D expenditure amounted to RMB1,954 million, representing an increase of 15.69% YOY. In particular, the R&D expenses amounted to RMB1,562 million, representing an increase of 29.73% YOY. As at the end of the Reporting Period, there were nearly 2,600 R&D personnel, of which approximately 1,400 persons obtained master’s degree or above). The Group had 240 major pipeline innovative drugs, generic drugs, biosimilars and consistency evaluation items of generic drugs, of which 72 were innovative drugs.

In June 2021, Yi Kai Da of Fosun Kite, a joint venture, became the first CAR-T cell therapy product approved for launch in China. It is mainly used for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. In August 2021, National Medical Products Administration ("NMPA") also included its new indications in the Drug List of the Procedure for Breakthrough Therapy Designation. It shows the clinical advantages and potential of this drug in the treatment of relapsed or refractory indolent non Hodgkin’s lymphoma. Fosun Kite is expanding the indications actively, optimizing costs continuously, and exploring diversified payment methods including commercial insurance to increase the product accessibility to benefit more patients.

COMIRNATY (mRNA COVID-19 vaccine, also known as BNT162b2) has been included in the government vaccination programs in Hong Kong SAR and Macau SAR. During the Reporting Period, the vaccine has contributed revenue of over RMB500 million. Besides, Fosun Pharma has planned to supply 15 million doses of mRNA COVID-19 vaccine to Taiwan, which will be donated by the Buyers to the disease control authority for local vaccination. Meanwhile, phase II clinical trials of mRNA COVID-19 vaccine BNT162b2 in Chinese Mainland (excluding Hong Kong, Macau and Taiwan regions) and other works were also progressing in an orderly manner.

Stable growth of core pharmaceutical manufacturing business and multiple innovative products launched to improve product structure

During the Reporting Period, the revenue from core pharmaceutical manufacturing segment maintained steady growth and the product structure continued to be optimized. In the first half of 2021, the pharmaceutical manufacturing segment generated revenue of RMB12,248 million, representing an increase of 22.33% YOY. The R&D expenditure of pharmaceutical manufacturing segment was RMB1,777 million, representing an increase of 15.31% YOY, accounting for 14.51% of the revenue of the pharmaceutical manufacturing segment.

Fosun Pharma is committed to promoting innovative R&D, and is oriented towards fulfilling unmet clinical needs and improving products’ accessibility, accelerating the implementation of innovative technologies and products. After over a decade of continuous investment, many varieties such as Han Li Kang (Rituximab Injection), Han Qu You (Trastuzumab Injection), Su Ke Xin (Avatrombopag Maleate Tablets), Han Da Yuan (Adalimumab Injection) and Yescarta have been approved and sold in large quantities in the past two years,promoting sustainable growth in the Group’s performance.

During the Reporting Period, the sales volume of self-developed product Han Li Kang (Rituximab Injection) achieved substantial sales growth. In the first half of the year, it contributed revenue of RMB724 million, representing an increase of 223.21% YOY. Han Qu You (Trastuzumab Injection) and Su Ke Xin (Avatrombopag Maleate Tablets), which went launched in 2H 2020, recorded revenue of RMB325 million and RMB206 million respectively, in 1H 2021. Within the Reporting Period, revenue of Gland Pharma’s increased by 32.08% YOY, benefited from the contribution from Micafungin, Enoxaparin Sodium Injection and f new products launch. In addition, Gland Pharma continued to optimize the life cycle management of existing products and expand marketing channels, including the sales revenue of Atomolan Tablets (Glutathione Tablets) increased by 60.70% YOY.

Initial integration of diagnosis and medical aesthetic business completed with quality and efficiency improved

During the Reporting Period, Fosun Pharma’s medical device business has initially formed three major business divisions with medical cosmetology, respiratory care, and professional medical care. In the medical cosmetology field, while actively expanding its existing energy-based medical aesthetics equipment business, Sisram Medical carried out business integration on strategic tracks such as aesthetic dentistry and injectable.

In the first half of 2021, Fosun Pharma has actively promoted strategic upgrading and internal integration in the diagnosis segment. According to the business focus and characteristics of the subsidiaries under the diagnosis segment, the Group specified the positioning and functions of each of these subsidiaries as R&D and manufacturing center, differentiated instrument R&D platform, inspection service business platform and reagent manufacturing base. Centered on six major therapeutic areas (tumor, infection, digestion and metabolism, reproduction, cardiovascular, and central nervous system), Fosun Pharma has formed a cross-methodological product portfolio as well as a matrix R&D thinking that expands to different disease fields under the same methodology.

Further improved international operation capability with proportion of overseas revenue exceeds 30%

In the first half of 2021, Fosun Pharma implemented its internationalization strategy in terms of innovative R&D, BD, production, operation, and commercialization. The Group has cultivated a global BD team for deployment in frontier areas through R&D cooperation and license-in projects, while the drug clinical and registration team in the United States, Africa, Europe, and India, continued to strengthen overseas drug registration and application capabilities. At the same time, the Group accelerated the international quality system certification of domestic production lines, and deepened international marketing capabilities so as to further expand the international market. During the Reporting Period, Fosun Pharma achieved revenue of RMB5,198 million in regions outside Chinese Mainland and overseas countries, accounting for 30.66% of the total revenue.

Fosun Pharma has already set up a mature sales network with upstream and downstream customer resources in the English and French-speaking countries and regions in Sub-Saharan Africa. After years of attentive efforts, Fosun Pharma’s subsidiary, Gland Pharma has become one of India’s largest and fastest-growing companies, focusing on the production of injectables, and is active across over 60 countries.

Looking forward, Wu Yifang, Chairman and CEO of Fosun Pharma said, "The development of the entire pharmaceutical industry will be presented with both challenges and opportunities. In the second half of 2021. Fosun Pharma will endeavor to optimize product-oriented strategy, improve the Group’s R&D efficiency to strengthen the globalization, focused on innovation and international development. The Group will enhance innovative R&D capabilities, increase internationalized drug registration and declaration, and strive to develop strategic products. Whilst actively seeking opportunities for mergers and acquisitions to establish and promote the integration and synergy effects in the product lines and supply chains, the Group seeks to achieve continuous growth of its revenue and profits. At the same time, the Group will continue to optimize the operational efficiency in the healthcare service industry, accelerate the construction of competitive disciplines, enhance quality management, push forward the transformation of health industry to internet healthcare services and further promote breakthroughs in the consumer health sector so as to expand the operating scale in the segment and improve its capabilities in operation, management and internationalization."

Horizon Therapeutics plc to Participate in Upcoming Conferences

On August 23, 2021 Horizon Therapeutics plc (Nasdaq: HZNP) reported that the Company will participate in the following conferences (Press release, Horizon Therapeutics, AUG 23, 2021, View Source [SID1234586849]):

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Handelsbanken Life Science Innovation Day 2021 (Virtual)

Date: Wednesday, Aug. 25, 2021
Presentation time: 10 a.m. ET
Morgan Stanley 19th Annual Global Healthcare Conference (Virtual)

Date: Friday, Sept. 10, 2021
Presentation time: 10:15 a.m. ET
The conference presentations will be webcast live and may be accessed by visiting Horizon’s website at View Source A replay of each webcast will be available following the events.

Epigenomics AG: Securities prospectus for the issuance of a mandatory convertible bond in the amount of up to EUR 16.5 million approved by BaFin

On August 23, 2021 Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company" reported that the German Federal Financial Supervisory Authority (Bundesanstalt für Finanzdienstleistungsaufsicht, "BaFin") has today approved the securities prospectus required for the issuance of a subordinated mandatory convertible bond in an aggregate principal amount of up to EUR 16,500,000.00 (Press release, Epigenomics, AUG 23, 2021, View Source [SID1234586843]). The mandatory convertible bond may be converted into up to a total of 15,000,000 registered no-par value shares of the Company with a share in the Company’s share capital of up to a total of EUR 15,000,000.00. Accordingly, the conversion price will be EUR 1.10 per share, subject to any anti-dilution adjustments.

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The mandatory convertible bond consists of up to 165,000 notes with a nominal amount of EUR 100.00 each, which will initially be offered to the existing shareholders of Epigenomics AG by means of a rights offering. Shareholders will also be given the option of over-subscription. The rights offering is published on the Company’s website (View Source) and is expected to be published in the German Federal Gazette on August 26, 2021. The subscription period for the Company’s shareholders is scheduled to start on August 27, 2021, and to end on September 10, 2021 (including each of these two days). Stock exchange trading of the subscription rights on the Hamburg Stock Exchange is also expected to commence at the beginning of the subscription period on August 27, 2021.

The bonds are non-interest bearing (zero coupon) and have a term until September 29, 2027. In addition to the conversion rights of the holders or creditors of the bonds, the terms and conditions of the bonds also include a conversion obligation for all outstanding notes not yet converted at the end of their term.

As announced in the ad hoc announcements of June 11, 2021, and August 20, 2021, Epigenomics AG has entered into a back-stop agreement with its shareholder Deutsche Balaton Aktiengesellschaft, under which the latter has undertaken to acquire all notes in an aggregate principal amount of up to EUR 16,500,000.00 by exercising its subscription rights and by the acquisition of notes not subscribed via subscription rights and oversubscription rights. This obligation expires at the end of the year 2023.

Epigenomics AG plans to use the proceeds from the issuance of the mandatory convertible bond to finance its operations, in particular the further development of the blood-based colorectal cancer screening test Epi proColon Next-Gen. For this purpose, the Company plans to conduct a clinical study in the U.S.A., which is required to obtain approval for the test by the U.S. Food and Drug Administration (FDA). Preparations are currently underway for the clinical trial, which is scheduled to begin in the first half of 2022.

Viracta Therapeutics Reacquires Exclusive Development and Commercialization Rights for its All-Oral Combination Therapy in China

On August 23, 2021 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, reported that it has reacquired the exclusive rights to develop and commercialize its all-oral combination product candidate in the People’s Republic of China previously licensed to Shenzhen Salubris Pharmaceuticals Co., Ltd. (Salubris) (Press release, Sunesis, AUG 23, 2021, View Source [SID1234586838]). Pursuant to the mutual termination agreement between Viracta and Salubris, all development and commercialization rights under the license have been returned to Viracta in exchange for a $4.0 million cash payment to Salubris.

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"We thank the Salubris team for their support of Viracta and their collaborative contributions. As Viracta’s strategic focus remains in precision oncology and Salubris focuses their development efforts on cardiovascular and related disease areas, we agreed the reversion of these rights to Viracta was in the best interest of patients," said Ivor Royston, M.D., President and Chief Executive Officer of Viracta. "China represents an important geographical region for the treatment of patients with EBV-associated cancers. We believe regaining the development and commercial rights in China will enable Viracta to expand our global development strategy and has the potential to unlock significant, long-term and unencumbered value to our shareholders."

Viracta’s combination therapy of nanatinostat, its proprietary investigational drug, and valganciclovir is currently being evaluated in a global Phase 2 pivotal trial for the treatment of patients with Epstein-Barr virus-positive (EBV+) lymphoma. Viracta has also received United States Food and Drug Administration clearance of an Investigational New Drug application to proceed into a global Phase 1b/2 trial evaluating its combination therapy in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors. Initiation of this Phase 1b/2 trial is expected in the second half of 2021.

About Nanatinostat

Nanatinostat (VRx-3996) is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing viral genes that are epigenetically silenced in EBV-associated malignancies. The nanatinostat and valganciclovir combination is being investigated in various subtypes of relapsed/refractory EBV+ lymphoma in multiple clinical trials, including a registration-enabling global, multicenter, open-label basket trial.

Emergent BioSolutions to Participate in Investor Conferences

On August 23, 2021 Emergent BioSolutions Inc. (NYSE: EBS) repored that members of the company’s senior management team will participate in the following investor conferences (Press release, Emergent BioSolutions, AUG 23, 2021, View Source [SID1234586836]):

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Three Part Advisors IDEAS Midwest Conference
August 25-26, 2021
Pre-recorded presentation available on August 26; 1-on-1 meetings on August 26
Wells Fargo 2021 Virtual Healthcare Conference
September 9-10, 2021
Fireside chat on September 9 at 9:20 am ET; 1-on-1 meetings all day
Morgan Stanley 19th Annual Global Healthcare Conference
September 9-10 & 13-15, 2021
Fireside chat on September 9 at 3:30 pm ET; 1-on-1 meetings all day
Baird’s 2021 Global Healthcare Conference
September 14-15, 2021
Fireside chat on September 14 at 4:55 pm ET; 1-on-1 meetings all day
Singular Research Compelling Values Webinar
September 16, 2021
Company presentation schedule will be posted on website
Cantor 2021 Virtual Global Healthcare Conference
September 27-30, 2021
Fireside chat on September 27 at 4:00 pm ET; 1-on-1 meetings all day
For conferences where a presentation is planned, the company’s webcast presentation may include a discussion of the company’s recent business developments as well as its financial results and guidance. The webcast will be available both live, if possible, and by replay, and will be accessible from the Emergent website.