SHANGHAI and SOUTH SAN FRANCISCO, Calif., May 16, 2019 /PRNewswire/ — Shanghai ChemPartner a leading global Contract Research Organization (CRO), along with Berkeley Lights, Inc. (BLI), the leader in digital cell biology, announced today they have taken the next important step in their collaboration. ChemPartner has installed BLI’s Beacon® Optofluidic platform and is the first full-service CRO to offer B Cell antibody discovery services to its global client base. This new capability enhances ChemPartner’s current antibody discovery platform and augments the end-to-end solutions the company offers for clients and partners.
Through the collaboration, and with BLI’s support, ChemPartner will combine BLI’s antibody discovery workflow for B cells with ChemPartner’s assays. The Beacon® platform is capable of automatically screening tens of thousands of plasma B cells or gene-edited cells, which speeds up a traditionally time-consuming, manual process. Cell characterizations are performed on the platform through a variety of serial or multiplexed fluorescence assays to determine antigen-specific binding to membrane-bound targets on live cells, relative affinity, and functional response with reporter cells. Individual cells with the desired characteristics are selected and exported for genomic profiling or further interrogation. The Beacon® platform enables plasma B cell characterization in less than a day.
“The next step of our collaboration builds on a very successful Proof of Concept study that we completed and presented together with BLI at the Antibody Engineering and Therapeutics conference in December”, said Wei Tang, CEO of ChemPartner. “We very much look forward to building on the foundation of this relationship to give ChemPartner’s diverse global client base access to this state-of-the-art technology in antibody discovery.”
“This collaboration has demonstrated the flexibility of the Beacon® platform as we incorporated the ChemPartner assays to further accelerate antibody discovery,” said Andy Last, Chief Commercial Officer at Berkeley Lights, Inc. “We look forward to continuing to work with ChemPartner to further deliver efficiencies to their global clients.”
Shanghai ChemPartner, offers a broad range of drug discovery and development capabilities including discovery biologics discovery, chemistry and medicinal chemistry, biology and pharmacology, DMPK and exploratory toxicology, CMC and Biologics CMC. Shanghai ChemPartner serves a diverse global client base and has laboratories, business offices, and representatives in the US, Europe, China, and Japan.
About Berkeley Lights:
Berkeley Lights, Inc. (BLI)Berkeley Lights is a digital cell biology company that develops and commercializes platforms for the acceleration of discovery, development, and delivery of cell based products and therapies. At the intersection of biology, technology and information, our platforms automate the manipulation, analysis and selection of individual cells, creating ultimate scalability and deep cell insights. The Beacon platform* is ideally suited for cell line development, antibody discovery (including direct B-cell workflows), gene editing, and antibody engineering workflows. Each workflow provides a 100 fold increase in insights, 10 times faster, at a fraction of the cost.
* For Research Use Only. Not for use in diagnostic procedures.
TAIPEI, Taiwan, May 17, 2019 /PRNewswire/ — InnoVEX is the startup focused special exhibition of COMPUTEX. Started in 2016, the event has continued to see significant growth every year. InnoVEX saw a 20% growth between 2018 and 2019; with current exhibitors numbering 467 startup teams from 24 countries & regions and over 20,000 visitors expected to join InnoVEX. To ensure a better, more comfortable experience for the large number of expected visitors, exhibitors, and VIPS; InnoVEX will be held in a larger venue: TWTC Hall 1.
InnoVEX returns from May 29-31, 2019 with more startups and networking programs
Being related to COMPUTEX puts InnoVEX in a special position as both visitors and exhibitors of COMPUTEX can freely enter InnoVEX showgrounds. This means InnoVEX exhibitors can get a targeted audience who are especially interested in ICT and innovation; including potential investors, customers, or buyers.
7 Main Topics of Forum, Over 40 Speakers
The 2019 InnoVEX Forum will take place from May 29 – 31 in the InnoVEX Center Stage. This year, the forum covers a wide range of topics: AI, Biotech, Blockchain, IoT Application, Smart Machinery, Sports Tech, and Startup Ecosystem. In the InnoVEX Forum, over 40 speakers from leading companies, accelerators and investors around the world will share their insights on the topics through keynote speeches and panel discussions.
This year, the speaker will include:
John Jorritsma, Mayor of Eindhoven who will share his insights on the opportunities and use cases of blockchain applications in smart cities
Zvika Popper, the VP of Strategy of HYPE Sports Innovation. Mr. Popper will speak about the sportstech ecosystem, the business models, and how the relation between fans and athletes all contribute to the sportstech ecosystem.
Ravi Belani, the Managing Director of Alchemist Accelerator. Joining a panel discussion as a representative of Silicon Valley Accelerators, Mr. Belani will share the methods to connect with global accelerators to the panel audience.
Dominik Schiener, the Co-Chairman of the Boards of Directors & Founder of IOTA Foundation. He will give a keynote and join a panel discussion on blockchain applications in cybersecurity.
Other speakers include the Ecosystem Manager of Arm, Chairman of the European Chamber of Commerce Taiwan, professors & academics from Taiwan top universities; as well as speakers from Qualcomm Incorporated, Nomura Research Institute and more. For more details on the InnoVEX Forum, please visit the InnoVEX website and save a seat for the InnoVEX Forum.
Exhibit, Pitch, Match, Expand
As an exhibition, InnoVEX always attracts hundreds of global startups and thousands of visitors. There are currently 467 InnoVEX exhibitors from 24 countries & regions. The top 5 industries of the teams are: AI, IoT, Health & Biotech, AR/VR/XR, and Consumer Tech.
Startups that will join InnoVEX include:
Beseye — an AI startup from Taiwan with focus on AI applications in security by identifying human faces, characteristics, behavior, and facial recognition.
WeavAir — an award-winning Canadian IoT startup that uses various metrics as well as predictive algorithms for indoor air quality management.
Klenic Myanmar — the first solution providing startup from Myanmar that improves healthcare efficiency and accuracy.
Veyond Reality — a startup from Taiwan that develops innovative educational solutions by utilizing AR/VR/XR.
Neonode Technologies — a Swedish startup that develops, manufactures, and sells sensor modules based on its patented optical reflective technology.
Visitors can get more information on all exhibiting startups in the InnoVEX website’s Exhibitors Directory page.
143 global startups from 19 countries and regions registered for the InnoVEX Pitch Contest where a prize pool of USD 420,000 awaits them. This year’s grand prize is the Taiwan Tech Award which is worth USD 100,000; sponsored by Taiwan Tech Arena (Ministry of Science and Technology). Other special prizes include the Startup Terrace Awards worth USD 60,000 for 5 startups; Taiwania Innovation Award for startups in IoT or biomedical field worth USD 10,000; and Qualcomm Innovation Award will be awarded to startups in AI & Big Data, AR/VR/XR, Hardware & IoT, or 5G applications, worth USD 10,000. The InnoVEX Pitch Contest Semifinal will be held in the Pi Stage on May 29 and May 30; while the Final stage will be held in the Center Stage on May 31.
The InnoVEX Pi Stage is the place for startup demonstrations, pitch, and matchmaking sessions. During the three days of InnoVEX, in total five events will be held in the Pi Stage to promote startups to the global stage and help them find opportunities around the world.
The Pi Stage will have 4 events in addition to the InnoVEX Pitch Contest Semifinal Stage:
May 30, 09:45 – 12:00: InnoVEX Matchmaking Powered by TTA x AAN: a matchmaking event for startups to meet international accelerators from Asia Pacific. The participating accelerators include: Startup GoGo, HKSTP, TinkBig Ventures, QBO Innovation Hub, and Schoolab.
May 30, 14:00 – 17:30: InnoVEX Matchmaking Powered by TTA x TIEC: an industrial matchmaking to connect startups with potential investors, partners, and more. The participating investors include: Taya Venture Capital, Darwin Ventures, CIDC Consultants Inc., SinoPac, and Samsung Next.
May 31, 10:00 – 12:00: Global Demo Day: a startup demo platform featuring startups from France, Poland, Canada, and Philippines. In addition, the participating trade offices will also introduce their startup programs in this event.
May 31, 13:00 – 17:00: Tourism Innovation & Awards: the final stage of a pitch contest supported by the Tourism Bureau under the Ministry of Transportation & Communications. This event aims to find the best method to enhance tourism through ICT applications.
Each event will aim to connect startups with potential investors, partners, and other resources to help them grow and expand globally; including exposure to and from global media. The events at Pi Stage are open for public participation and InnoVEX visitors are welcome to join the events to see the innovations from around the world.
Innovation Does not Stop at Sunset
InnoVEX is not limited to the showgrounds only. As deals, negotiations, and businesses do not stop at sunset; neither does InnoVEX. On May 30, InnoVEX will have a night networking party titled “InnoVEX Taiwan Tech @Night”. An exclusive invite-only event, the party will have invite VIPs from the InnoVEX organizer, government & trade office representatives, startups, global investors, leading ICT companies, and more to both network and relax. Invited guests will have the opportunity to enjoy the night citylights, good food, and music; all while networking, dealmaking, and matchmaking.
Join InnoVEX 2019 from May 29 to 31
InnoVEX 2019 is open for participation from everyone. Tech enthusiasts, young entrepreneurs, and the general public can enter the InnoVEX showgrounds with the COMPUTEX badge or InnoVEX pass. Get the entry pass in the InnoVEX website: http://innovex.computex.biz
About the organizer: Taipei Computer Association
Taipei Computer Association (TCA), the co-organizer of COMPUTEX and InnoVEX was established in 1974; and is the leading industrial organization in Taiwan. Its 4,000 members engages various fields such as software, hardware, semiconductors and components, manufacture, sales, network communication service, etc., thereby generating over 80% of the total production value of Taiwan’s Information Communication Technology (ICT).
BOONE, North Carolina, May 15, 2019 /PRNewswire/ — Pneuma Respiratory, Inc., developer of a proprietary breath-activated digital inhaler (BDI), and Leads Biolabs Inc. announce an agreement granting Pneuma an exclusive license to develop Leads Biolabs’ panel of immuno-oncology monoclonal antibodies and fusion protein molecules for the pulmonary delivery of Leads’ antibodies and molecules. Using Pneuma’s digital inhaler platform, the agreement provides access to the untapped potential of pulmonary delivery of Leads’ immuno-oncology therapies in the treatment of oncologic or immune-mediated lung diseases.
In a recent publication, Pneuma announced the completion of a study demonstrating the feasibility of antibody delivery to the lungs via its digital inhaler platform. This study, conducted in an animal model, indicates that the Pneuma digital inhaler platform may provide a method for the pulmonary delivery of monoclonal antibody therapies, enabling the targeted treatment of oncologic or immune-mediated lung diseases.
“This collaboration is an exciting development for the field of immuno-oncology,” said Ronald Bukowski, MD, physician emeritus, Cleveland Clinic Foundation. “Approaches utilizing the regional administration of novel checkpoint inhibitors may provide new treatment opportunities for patients with a variety of malignancies.”
“We are pleased to enter into a license agreement for Leads Biolabs monoclonal antibody portfolio,” said Pneuma Chief Executive Officer and co-founder Eric Hunter. “We look forward to working with their team to conduct studies that may lead to positive change in the future treatment of non-small cell lung cancer.”
Dr. Xiaoqiang Kang, Chairman and CEO of Leads Biolabs, said: “We are very excited to have this license agreement with Pneuma Respiratory. The commitment by a leader in digital pulmonary delivery of drugs is an endorsement of the value of our portfolio. We believe that Pneuma’s digital inhaler technology combined with our antibody drugs will create very exciting new opportunities for both companies. We look forward to working with Pneuma to move our candidates into the clinic as quickly as possible.”
About Pneuma Respiratory: Launched in 2015, Pneuma Respiratory is a pharmaceutical company based in Boone, North Carolina. With a global team of researchers, physicians, designers and engineers, Pneuma has created the first fully integrated digital breath-activated inhaler. This inhaled delivery system includes digital micro-fluidics integrated with Bluetooth technology capable of providing feedback on drug delivery to patients, family members, and health care providers. Using Pneuma’s digital droplet ejector technology, Pneuma’s device has the potential to ultimately deliver a spectrum of novel therapies, including biologics, to the lungs. The first breath-activated digital inhaler (BDI) is currently in use for investigational purposes only and is not yet commercially available. For more information, please visit www.pneumarespiratory.com.
About Leads Biolabs, Inc.: Leads Biolabs, Inc., a Maryland Corporation, is the fully-owned subsidiary of a US-Sino joint venture company, Nanjing Leads Biolabs Co., Ltd. based in Nanjing, China. Leads Biolabs is an innovation-driven biopharmaceutical company with a rich portfolio of more than 10 novel mono-targeted or bispecific antibody drug projects for cancer immunotherapy and other major diseases to fulfill unmet medical needs. For more information, please visit www.leadsbiolabs.com.
DARMSTADT, Germany and NEW YORK, May 15, 2019 /PRNewswire/ —
Not intended for US, Canada and UK-based media
BAVENCIO is the first anti-PD-L1 in combination with axitinib approved by FDA for first-line treatment of patients with advanced renal cell carcinoma (RCC)
Phase III study showed combination significantly lowered risk of disease progression or death by 31% and extended progression-free survival by 5.4 months for patients with advanced RCC compared with sunitinib
Combination approved based on Phase III data in an overall population that included patients regardless of PD-L1 expression and across favorable, intermediate and poor prognostic groups
Additional regulatory reviews for BAVENCIO plus axitinib in advanced RCC are underway worldwide, including in the European Union and Japan
Merck and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) in combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This is the first FDA approval for an anti-PD-L1 therapy as part of a combination regimen for patients with advanced RCC. The approval of BAVENCIO in combination with axitinib was based on positive results from the Phase III JAVELIN Renal 101 study (NCT02684006), in which the combination significantly improved median progression-free survival (PFS) compared with sunitinib by more than five months in the intent-to-treat (ITT) patient population (HR: 0.69 [95% CI: 0.56–0.84]; 2-sided p-value=0.0002; median PFS for BAVENCIO in combination with axitinib: 13.8 months [95% CI: 11.1-NE]; sunitinib: 8.4 months [95% CI: 6.9-11.1]). The ITT population included patients regardless of PD-L1 expression and across IMDC (International Metastatic Renal Cell Carcinoma Database) prognostic risk groups (favorable 21%, intermediate 62% and poor 16%).1
“As we look to continue to improve outcomes for people with advanced RCC, new treatment approaches have the potential to benefit patients,” said Robert J. Motzer, M.D., Jack and Dorothy Byrne Chair in Clinical Oncology, Memorial Sloan Kettering Cancer Center, New York, US, and principal investigator for JAVELIN Renal 101. “With today’s FDA approval of avelumab in combination with axitinib, we can now offer patients with advanced RCC a first-line treatment option that combines a PD-L1 immunotherapy with a well-known VEGFR TKI to provide a significant reduction in the risk of disease progression or death and doubling of the response rate compared with sunitinib.”
RCC is a type of cancer where PD-L1 expression may contribute to inhibition of the immune response against the tumor.2 It is also a highly vascular tumor, in which vascular endothelial growth factor (VEGF) plays a key role.3
“A kidney cancer diagnosis is life-changing for both patients and their loved ones, and having a treatment strategy for their disease quickly becomes a priority,” said Dena Battle, President, KCCure. “The approval of new treatments such as BAVENCIO in combination with axitinib gives patients with advanced RCC much-needed options.”
There is a significant unmet need for first-line treatments that delay progression and have an acceptable safety profile. Approximately 20% to 30% of patients are first diagnosed with RCC at the advanced stage, and 30% of patients treated for an earlier stage go on to develop metastases.4,5 About half of patients living with advanced RCC do not go on to receive additional treatment after first-line therapy,6,7 for reasons that may include poor performance status or adverse events from their initial treatment.6,8,9
“Today’s approval of BAVENCIO in combination with axitinib builds on Pfizer’s long heritage in bringing innovation to the RCC community with the hopes of making a significant and meaningful impact on the lives of patients,” said Andy Schmeltz, Global President, Pfizer Oncology. “For more than 12 years, Pfizer has led the field in its commitment to developing new treatments for patients with advanced kidney cancer.”
“With today’s FDA approval of BAVENCIO in combination with axitinib, we feel privileged that we can offer patients with first-line advanced renal cell carcinoma a new treatment option,” said Rehan Verjee, President of EMD Serono, Merck’s Biopharma business in the US, and Global Head of Innovative Medicine Franchises, Merck.
In JAVELIN Renal 101, the objective response rate (ORR) was doubled in the ITT population with BAVENCIO in combination with axitinib versus sunitinib (51.4% [95% CI: 46.6-56.1] vs. 25.7% [95% CI: 21.7-30.0]). With a median overall survival (OS) follow-up of 19 months, data for the trial’s other primary endpoint of OS were immature, with 27% of deaths in the ITT population, and the trial is continuing as planned. The most common adverse reactions (≥20%) were diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache.Serious adverse reactions occurred in 35% of patients receiving BAVENCIO in combination with axitinib. The incidence of major adverse cardiovascular events (MACE) was higher with BAVENCIO in combination with axitinib versus sunitinib.1 Findings from the study have been published in The New England Journal of Medicine.10
The European Medicines Agency (EMA) validated the Type II variation application for BAVENCIO in combination with axitinib in advanced RCC in March 2019, and a supplemental application for BAVENCIO in combination with axitinib in unresectable or metastatic RCC was submitted in Japan in January 2019. The combination of BAVENCIO and axitinib is only approved for the first-line treatment of advanced RCC in the United States.
About Renal Cell Carcinoma In 2019, an estimated 73,820 new cases of kidney cancer will be diagnosed in the US, and approximately 14,770 people will die from the disease.11 RCC is the most common form of kidney cancer, accounting for about 2% to 3% of all cancers in adults.12,13 Approximately 20% to 30% of patients with kidney cancer are first diagnosed at the advanced stage.4 The five-year survival rate for patients with metastatic RCC is approximately 12%.14
About the JAVELIN Renal 101 study The Phase III JAVELIN Renal 101 study is a randomized (1:1), multicenter, open-label study of BAVENCIO in combination with axitinib in 886 patients with untreated advanced RCC regardless of tumor PD-L1 expression [intent-to-treat (ITT) population]. Patients with autoimmune disease or conditions requiring systemic immunosuppression were excluded. The major efficacy outcome measures were PFS as assessed by a Blinded Independent Central Review (BICR) using RECIST v1.1 and OS in patients with PD-L1-positive tumors using a clinical trial assay (PD-L1 expression level ≥1%). If PFS was statistically significant in patients with PD-L1-positive tumors, it was then tested in the ITT population. The hazard ratio for PFS in patients with PD-L1-positive tumors was HR 0.61 (95% CI: 0.48, 0.79). PFS and OS in the ITT population, overall response and safety are included as secondary endpoints. The study is continuing for OS.
About the JAVELIN Clinical Development Program The clinical development program for avelumab, known as JAVELIN, involves at least 30 clinical programs and about 10,000 patients evaluated across more than 15 different tumor types. In addition to RCC, these tumor types include gastric/gastro-esophageal junction cancer, head and neck cancer, Merkel cell carcinoma, non-small cell lung cancer, and urothelial carcinoma.
About BAVENCIO®(avelumab) BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.15-17 BAVENCIO has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.17-19 In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.
BAVENCIO Approved Indications In September 2017, the European Commission granted conditional marketing authorization for BAVENCIO as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC). BAVENCIO is currently approved for patients with MCC in more than 45 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.
BAVENCIO® (avelumab) in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
BAVENCIO Safety Profile from the EU Summary of Product Characteristics (SmPC) The special warnings and precautions for use for BAVENCIO include infusion-related reactions and immune-related adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction, and other adverse reactions).
The SmPC list of the most common adverse reactions in patients with solid tumors includes fatigue, nausea, diarrhea, decreased appetite, constipation, infusion-related reactions, and weight loss and vomiting.
Axitinib Important Safety Information from the US FDA-Approved Label In the study of advanced RCC after failure of one prior systemic therapy, the warnings and precautions for axitinib include hypertension, including hypertensive crisis, arterial and venous thrombotic events, hemorrhagic events, cardiac failure, gastrointestinal perforation and fistula, hypothyroidism, wound healing complications, reversible posterior leukoencephalopathy syndrome (RPLS), proteinuria, liver enzyme elevation, hepatic impairment, and fetal harm during pregnancy.
Common adverse events (reported in at least 20% of patients) in patients receiving axitinib were diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia, hand-foot syndrome, weight decreased, vomiting, asthenia, and constipation.
About Merck-Pfizer Alliance Immuno-oncology is a top priority for Merck and Pfizer. The global strategic alliance between Merck and Pfizer enables the companies to benefit from each other’s strengths and capabilities and further explore the therapeutic potential of BAVENCIO, an anti-PD-L1 antibody initially discovered and developed by Merck. The immuno-oncology alliance is jointly developing and commercializing BAVENCIO. The alliance is focused on developing high-priority international clinical programs to investigate BAVENCIO as a monotherapy as well as combination regimens, and is striving to find new ways to treat cancer.
All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.
About Merck Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 52,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – Merck is everywhere. In 2018, Merck generated sales of € 14.8 billion in 66 countries.
Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials.
Pfizer Inc.: Working together for a healthier world® At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
Pfizer Disclosure Notice The information contained in this release is as of May 14, 2019. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about BAVENCIO (avelumab), including a new indication approved in the U.S. for BAVENCIO in combination with axitinib for the treatment of patients with advanced renal cell carcinoma, the alliance between Merck and Pfizer involving BAVENCIO and clinical development plans, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of BAVENCIO and axitinib; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data and uncertainties regarding whether the other primary endpoint of JAVELIN Renal 101 will be met; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications may be filed for BAVENCIO in combination with axitinib in any other jurisdictions or in any jurisdictions for any other potential indications for BAVENCIO or combination therapies; whether and when the pending applications in the European Union and Japan for BAVENCIO in combination with axitinib may be approved and whether and when regulatory authorities in any jurisdictions where any other applications are pending or may be submitted for BAVENCIO or combination therapies, including BAVENCIO in combination with axitinib may approve any such applications, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy, and, if approved, whether they will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of BAVENCIO or combination therapies, including BAVENCIO in combination with axitinib; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
Weinstock M and McDermott D. Targeting PD-1/PD-L1 in the treatment of metastatic renal cell carcinoma. Therapeutic Advances in Urology. 2015;7(6):365-377.
Roskoski R Jr. Vascular endothelial growth factor (VEGF) and VEGF receptor inhibitors in the treatment of renal cell carcinomas. Pharmacological Research. 2017;120:116-132.
Ljungberg B, Campbell S and Cho H. The Epidemiology of renal cell carcinoma. European Urology. 2011;60:615-621.
Klatte T, Rossi SH, Stewart GD. Prognostic factors and prognostic models for renal cell carcinoma: a literature review. World Journal of Urology. 2018;36(12):1943-1952.
Eggers H, Ivanyi P, Hornig M and Grünwald V. Predictive Factors for Second-Line Therapy in Metastatic Renal cell Carcinoma: A Retrospective Analysis. Journal of Kidney Cancer and VHL. 2017;4(1):8-15.
Motzer R, et al. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. The New England Journal of Medicine. 2018;378:1277-1290.
Eichelberg C, et al. SWITCH: A Randomised, Sequential, Open-label Study to Evaluate the Efficacy and Safety of Sorafenib-sunitinib Versus Sunitinib-sorafenib in the Treatment of Metastatic Renal Cell Cancer. European Urology. 2015;68;837-847.
Motzer R, et al. Phase II Randomized Trial Comparing Sequential First-Line Everolimus and Second-Line Sunitinib Versus First-Line Sunitinib and Second-Line Everolimus in Patients With Metastatic Renal Cell Carcinoma. Journal of Clinical Oncology. 2014;32:2765-2772.
Motzer R, et al. Avelumab plus Axitinib versus Sunitinib for Advanced Renal Cell Carcinoma. The New England Journal of Medicine. 2019;380:1103-1115.
Dolan DE, Gupta S. PD-1 pathway inhibitors: changing the landscape of cancer immunotherapy. Cancer Control. 2014;21(3):231-237.
Dahan R, Sega E, Engelhardt J, Selby M, Korman AJ, Ravetch JV. FcγRs modulate the anti-tumor activity of antibodies targeting the PD-1/PD-L1 axis. Cancer Cell. 2015;28(3):285-295.
Boyerinas B, Jochems C, Fantini M, et al. Antibody-dependent cellular cytotoxicity activity of a novel anti-PD-L1 antibody avelumab (MSB0010718C) on human tumor cells. Cancer Immunology Research. 2015;3(10):1148-1157.
Kohrt HE, Houot R, Marabelle A, et al. Combination strategies to enhance antitumor ADCC. Immunotherapy. 2012;4(5):511-527.
Hamilton G, Rath B. Avelumab: combining immune checkpoint inhibition and antibody-dependent cytotoxicity. Expert Opinion on Biological Therapy. 2017;17(4):515-523.
SINGAPORE, May 13, 2019 /PRNewswire/ — Mundipharma has extended its portfolio of nutraceuticals by launching Maxvida(TM) – a balanced nutritional supplement with 32 key nutrients – in Vietnam.
Mundipharma will subsequently look at other countries in the region to distribute the product, which was developed in the USA by Signutra(TM).
Raman Singh, CEO, Mundipharma, said: “2019 is our first year providing nutraceuticals and is the most recent example of how rapidly our consumer health portfolio is expanding – from just antiseptics a few years ago to a wide range of categories and a large number of products today. We will be actively planning a wider roll-out of Maxvida(TM) and will also continue to expand our nutraceuticals portfolio.
“We’re excited to work with SignutraTM to be providing this excellent product in Vietnam, where nutrition is an issue, because it provides significant health benefits for consumers and patients.
According to a 2016 Vietnamese Ministry of Health report, 65.4% of elderly are experiencing health problems[i] and another report found that 77% of elderly patients in hospital are at risk of malnutrition[ii].
Maxvida(TM)contains Certi5(TM), which are five signature ingredients to help improve nutritional status and wellbeing comprising dual protein, dietary fibre, antioxidants hemo nutrients and bone nutrients.
Speaking at a scientific event preceding the launch, nutrition expert, Dr. Sander Hougee, PhD, from Netherlands, confirmed that all these ingredients are required in an optimal nutrition supplement.
About Maxvida(TM)
Maxvida(TM) is a balanced nutritional supplement that offers 32 key nutrients that cater to adult nutritional needs. Maxvida(TM) is crafted with high quality ingredients in just the right amounts. It supports daily nutrition by providing adequate levels of essential amino acids and complex carbohydrates to help meet adult nutritional needs. It also contains biotin that contributes to the normal functioning of the nervous system. It provides high quality proteins with Protein Digestibility Corrected Amino Acid Score (PDCAAS=1). Certi5(TM) signature nutrients in Maxvida(TM) are: Dual Protein – contains high quality Soy, Protein Isolate (SUPRO®) and Milk Protein with all essential amino acids for maintenance of bone and muscle mass, Dietary Fiber – Soluble and Insoluble fiber supports bowel movement and helps meet daily fiber needs, Antioxidants – Vitamin E, Vitamin C, and Selenium act as free radical scavengers, Hemo Nutrients – Iron, Folic acid, Vitamin B12, Vitamin B6, and Riboflavin support normal blood formation, Bone Nutrients – Calcium, Magnesium, Vitamin K, and Vitamin D support normal bone maintenance.
About Mundipharma
Mundipharma is a network of independent associated companies which are privately owned entities covering pharmaceutical markets in Asia-Pacific, Latin America, the Middle East and Africa. The headquarters for these territories is in Singapore. Mundipharma is a prime example of an organization that consistently delivers high-quality medicines while standing by the values it represents. Its mission is to alleviate the suffering of patients and to substantially improve their quality of life. Mundipharma is dedicated to bringing to patients the benefit of novel treatment options in fields such as pain, oncology, oncology supportive care, ophthalmology, respiratory disease and consumer healthcare.
About Signutra(TM)(TBC)
We are global experts in medical nutrition, who understand that nutrition science is common across the world, but nutrition demands are unique for each country.
In the first quarter of 2019, MLP Care’s revenue (BIST: MPARK) increased to TL933 million, up by 25%. When revenues of managed hospitals are included, revenue growth in Q1 2019 is at 28%
Adj. EBITDA increased by 20%, bringing EBITDA margin to 18.0%. Excluding one-off items, adj. EBITDA growth is at 29%
Net profit before tax turned into positive and TL12 million profit was recorded. Net profit came in at TL3 million
MLP Sağlık Hizmetleri A.Ş.(MLP Care), the leading private healthcare service provider in Turkey, announced its financial results for the first quarter of 2019.
Revenue increased to TL933 million, up by 25% compared to TL749 million of the last year’s first quarter revenue. When revenues of managed hospitals are included, revenue growth is at 28%. Adj. EBITDA increased by 20%.
Net profit before tax turned into positive and TL12 million profit was recorded in the first quarter compared to TL 31 million loss of the first quarter of 2018. MLP Care recorded a net profit of TL3 million due to strong operational performance and hedging. Net profit normalized for FX losses was at TL29 million.
In the first quarter, focus on maintaining strong growth continued in medical tourism, which is now accounting for 11.4% of total revenues.
Dr. Muharrem Usta, Chairman and Chief Executive Officer of MLP Care, commented on first quarter results as follows: “In the first quarter of 2019, we made a very good start to the year with revenues and EBITDA growing significantly above inflation. Foreign medical tourism (FMT) revenues were up by 79% y-o-y and FMT continues to be a strong growth engine going forward.
“In April 2019, we have signed an agreement with Bupa Acibadem Insurance Group, an important player in Turkey’s healthcare insurance market. With this agreement, insurance holders of the SenCart Membership Program mainly Bupa Acıbadem and Aksigorta, that covers 655 thousand people will be able to benefit from the healthcare services of Medical Park and Liv hospitals.
“We will focus on further improving our operations, strengthening our balance sheet and cash flow for the rest of 2019.”
ABOUT MLP CARE We are the largest private healthcare service provider in Turkey in terms of number of hospitals, beds and geographic scope based on our footprint of 31 hospitals and around 6,000 beds in 17 cities across the country. We treat more than 2 million people per year, with our patients primarily drawn from the upper-mid segments of the market. We provide a full range of healthcare services from gynaecology, cardiology, oncology, orthopaedics, intensive care to complex treatments such as organ and bone marrow transplants. As of March 31, 2019, we had more than 20,000 personnel, including over 2,200 physicians, managed by a head office team which integrates field operations, sets strategy and monitors real-time performance across all 31 hospitals.
ENQUIRIES Dr. Deniz Can Yücel Strategy and Investor Relations Director T +90-212-227-5555 (Ext: 1148) E deniz.yucel@mlpcare.com
SUWON, South Korea, May 10, 2019 /PRNewswire/ — OliX Pharmaceuticals, Inc. (KOSDAQ: 226950), a leading developer of RNAi therapeutics, announced today an expansion of its ocular disease pipeline. Specifically, the company announced that OLX304A has been added to develop an RNAi therapeutic with a novel target (undisclosed) for treatment of Retinitis Pigmentosa (RP) in a presentation at the Investor Relations Meeting in Seoul on May 10th.
“We have confirmed the strong potential of treating RP using our cp-asiRNA platform technology which is an optimal siRNA technology for developing ocular therapeutics. We look forward to advancing OLX304A as a highly innovative approach to benefit RP patients,” said Dong-ki Lee, Ph.D., the founder and CEO of OliX.
OLX304A is a program to develop a treatment that targets a single gene for RP patients regardless of their disease-causing gene mutation. This strategy is different from the conventional treatment development strategies for RP which target individual disease-causing genes.
An IND application of OLX304A program is planned to be submitted to the US FDA to initiate a Phase 1 within the first half of next year.
OliX Pharmaceuticals, Inc. OliX is a clinical stage pharmaceutical company developing therapeutics against a variety of disorders by down-regulating expression of disease-causing genes, based on its own proprietary RNAi technology. The company is currently developing novel therapeutic programs for treatment of various diseases with high unmet medical needs, including hypertrophic scar, dry & wet age-related macular degeneration (AMD), subretinal fibrosis, Retinitis Pigmentosa and idiopathic pulmonary fibrosis (IPF). Learn more: http://www.olixpharma.com/main/main.php
HANGZHOU, China, May 10, 2019 /PRNewswire/ — Today, Alibaba employees across the world joined together to celebrate Ali Day, an annual event honoring the tenacity and fighting spirit of their colleagues and their families during the Severe Acute Respiratory Syndrome crisis in China 16 years ago.
Two Alibaba mascots kicked off the group wedding celebration at this year’s Ali Day.
During the height of the outbreak in May 2003 in China, one employee was thought to have contracted the deadly virus. The entire staff was ordered to self-quarantine at home. But instead of putting the business on hold, everyone, including family members, pulled together to keep the operation afloat.
Such determination and dedication prompted Alibaba Group founder Jack Ma in 2005 to declare May 10 as “Ali Day.” More than just a day of merriment, Ali Day is about paying tribute to employees and their family members, whom Ma often calls the company’s “biggest pillar.” It also underscores Alibaba’s values, placing “customers first, employees second and shareholders third.”
This year, Alibaba’s offices across all time zones held their own celebrations. Its main Xixi Campus in Hangzhou was transformed into a giant carnival, with musical and dance performances by employees throughout the day. There was a playground for children, arts-and-crafts corners and magic shows.
The highlight of each Ali Day is the “wedding,” or a celebration of Alibaba couples who married over the previous year. This year was no exception, with 102 pairs of newlyweds, dressed in crimson traditional Chinese attire, receiving sage advice from Ma, himself, who presided over the ceremony. The number 102 symbolizes the minimum number of years Ma has said he wants Alibaba to last, spanning three centuries.
On Ali Day, executives personally extend their gratitude to family members of Alibaba employees. This year, Alibaba Group Vice Chairman Joe Tsai invited the entire New York staff and guests to a New York Liberty WNBA basketball game. In Hangzhou, Alibaba CEO Daniel Zhang and Chief People Officer Judy Tong answered questions from employees’ family members.
–1Q19 Total Sales Up 15.4% YoY in USD terms, or 22.3% YoY in RMB terms; Net Income Up 19.3% YoY to $37.7 Million; Non-GAAP Adjusted Net Income Up 14.3% YoY in RMB terms —
BEIJING, May 11, 2019 /PRNewswire/ — China Biologic Products Holdings, Inc. (NASDAQ: CBPO, “China Biologic” or the “Company”), a leading fully integrated plasma-based biopharmaceutical company in China, today announced its unaudited financial results for the first quarter of 2019.
First Quarter 2019 Financial Highlights
Total sales in the first quarter of 2019 increased by 22.3% in RMB terms and 15.4% in USD terms to $129.8 million from $112.5 million in the same quarter of 2018.
Gross profit increased by 8.6% to $85.6 million from $78.8 million in the same quarter of 2018. Gross margin decreased to 65.9% from 70.0% in the same quarter of 2018.
Income from operations increased by 12.8% to $44.0 million from $39.0 million in the same quarter of 2018. Operating margin decreased to 33.9% from 34.7% in the same quarter of 2018.
Non-GAAP adjusted income from operations increased by 10.5% in RMB terms and 4.2% in USD terms to $52.2 million from $50.1 million in the same quarter of 2018.
Netincomeattributable to the Company increased by 26.5% in RMB terms and 19.3% in USD terms, to $37.7 million from $31.6 million in the same quarter of 2018. Fullydilutedearningsper share increased to $0.94 compared to $0.92 in the same quarter of 2018.
Non-GAAP adjusted net income attributable to the Company increased by 14.3% in RMB terms and 7.7% in USD terms to $44.5 million from $41.3 million in the same quarter of 2018. Non-GAAP adjustedearningsper share decreased to $1.11 from $1.21 in the same quarter of 2018.
“China Biologic achieved better-than-expected financial results for the first quarter, with growth in operating profit that exceeded expectations. Despite this welcome news, the challenging policy headwinds and heightened competition within the Chinese plasma industry persist and we maintain our overall outlook for the year,” said Joseph Chow, Chairman of the China Biologic Board of Directors.
“This quarter’s outperformance in terms of operating profit growth can be largely attributed to higher-than-expected sales of albumin. This was due to a temporary shortage of albumin supply in the market related to lower import volumes combined with increased plasma fractionation capability at our new Shandong facility launched last February. However, sales of IVIG products did not meet our expectations, due to reduced purchase volumes at many regional hospitals as mandated by government controls on healthcare spending. The performance of our placenta polypeptide product was largely in line with expectations, with sales down 50% year over year. As market prices decline for our major products, our gross margin continues to be negatively impacted. Although our prior efforts and investments towards improving our sales and marketing capabilities have been successful in broadening our sales channel coverage and reducing Guizhou Taibang’s IVIG inventory, the prescription volumes of IVIG and certain high-unit-price coagulation products remain sluggish.”
“We recently received Dr. Bing Li’s resignation as CEO and also from the Board of Directors due to personal reasons. We thank Dr. Li for his contribution in helping China Biologic optimize our sales and marketing team and improve corporate governance. The Board has formed a search committee comprised of independent directors to seek a new CEO and in the interim has appointed me as the acting CEO.”
“Looking ahead to the rest of the year, given the relatively fixed annual volume of our available plasma inventory and the oversold albumin volume in the first quarter, the overall albumin sales growth rate in the remaining quarters of this year will likely decelerate. Our new sales and marketing talent will leverage our expanded sales coverage in various channels to offer a variety of products, with renewed efforts towards improving the prescription volumes at regional hospitals and educating doctors about the benefits of IVIG, PCC and other coagulation factor products in treating patients across a wide range of clinical indications. We expect these efforts to help decrease our IVIG inventory position, which is currently above the normal level, both internally and with our distributors.”
Share Repurchase Program
In late April 2019, the Company completed the share repurchase program previously authorized by its Board of Directors in 2018, repurchasing 1,074,376 shares at a total of $100 million.
In May 2019, the Company’s Board of Directors authorized a new share repurchase program under which China Biologic may repurchase up to US$150 million worth of shares over the next 12 months.
The Company’s repurchases may be made from time to time on the open market at prevailing market prices, in negotiated transactions off the market, in block trades or through other legally permissible means. The timing and extent of any purchases will depend upon market conditions, the trading price of its shares and other factors, and are subject to the restrictions relating to volume, price and timing under applicable law.
First Quarter 2019 Financial Performance
Total sales in the first quarter of 2019 increased by 22.3% in RMB terms, or 15.4% in USD terms, to $129.8 million from $112.5 million in the same quarter of 2018.
Total sales for biopharmaceutical products (including plasma products and placenta polypeptide products) increased by 22.2% in RMB terms, or 15.2% in USD terms, to $116.5 million from $101.1 million in the same quarter of 2018, as a result of increases in the sales of human albumin products and coagulation factor products, which was partly offset by decreases in the sales of IVIG and placenta polypeptide products. For plasma products, total sales in the first quarter of 2019 increased by 35.8% in RMB terms, or 28.0% in USD terms, to $108.8 million from $85.0 million in the same quarter of 2018.
Total sales for biomaterial products in the first quarter of 2019 increased by 23.8% in RMB terms, or 16.7% in USD terms, to $13.3 million from $11.4 million in the same quarter of 2018, as a result of higher sales concentration in higher-unit-price artificial dura mater products.
During the first quarter of 2019, human albumin and IVIG products remained the Company’s two largest sales contributors. Revenue from human albumin increased by 78.2% in RMB terms, or 68.0% in USD terms, from $33.8 million in the first quarter of 2018 to $56.8 million in the first quarter of 2019. Revenue from IVIG products decreased by 3.1% in RMB terms, or 8.8% in USD terms, from $31.8 million in the first quarter of 2018 to $29.0 million in the first quarter of 2019. As a percentage of total sales, sales from human albumin and IVIG products were 43.8% and 22.4%, respectively, in the first quarter of 2019.
The sales volume of human albumin products increased by 85.8% for the first quarter of 2019, primarily due to increased sales volumes in the distributor and pharmacy channels, supplemented by increased direct sales to hospitals and inoculation centers. The sales volume of IVIG products increased by 1.1% for the first quarter of 2019 as a result of increased sales through the distributor channel.
The average prices for human albumin and IVIG products decreased by 4.1% and 4.2%, respectively, in RMB terms in the first quarter of 2019 compared to the same quarter of 2018 because of higher sales volume in the distributor channel and lower prices to certain distributors reflecting intensified market competition for major plasma products. In USD terms, the average price for human albumin and IVIG products decreased by 9.5% and 9.7%, respectively, in the first quarter of 2019 compared to the same quarter of 2018.
Revenue from other immunoglobulin products increased by 6.6% in RMB terms, or 0.5% in USD terms in the first quarter of 2019 compared to the same quarter of 2018, reaching 10.1% of total sales as compared to 11.6% of total sales in the same quarter of 2018. The revenue increase was mainly attributable to increased sales volume of human tetanus immunoglobulin products.
Revenue from other plasma products, including human coagulation factor VIII, human prothrombin complex concentrate, and human fibrinogen products, increased by 64.2% in RMB terms, or 54.9% in USD terms, in the first quarter of 2019 compared to the same quarter of 2018, representing 7.6% of total sales in the first quarter of 2019. The growth mainly came from increased sales through the distributor channel.
Revenue from placenta polypeptide products decreased by 52.4% in USD terms for the first quarter of 2019 as compared to the same quarter of 2018, accounting for 5.9% of total sales compared to 14.3% of total sales in the first quarter of 2018, mainly in line with a decrease in sales volume as a result of the inclusion of placenta polypeptide products in regional adjuvant drug lists, which put a downward pressure on their prescription volume.
Cost of sales increased by 31.2% to $44.2 million in the first quarter of 2019 from $33.7 million in the same quarter of 2018. As a percentage of total sales, cost of sales increased to 34.1% from 30.0% in the same quarter of 2018, mainly because of decreased sales prices for most of the Company’s plasma products, increased plasma collection costs, and increased depreciation expenses due to the launch of the Company’s new facility in Shandong in February 2018.
Gross profit increased by 8.6% to $85.6 million in the first quarter of 2019 from $78.8 million in the same quarter of 2018. Gross margin was 65.9% and 70.0% in the first quarter of 2019 and 2018, respectively.
Total operating expenses in the first quarter of 2019 increased by $1.8 million, or 4.5%, to $41.6 million from $39.8 million in the same quarter of 2018. This increase mainly consisted of an increase of $3.2 million in general and administrative expenses, partially offset by a decrease of $2.0 million in selling expenses. As a percentage of total sales, total operating expenses decreased to 32.0% in the first quarter of 2019 from 35.4% in the same quarter of 2018.
Selling expenses in the first quarter of 2019 decreased by $2.0 million, or 9.7%, to $18.7 million from $20.7 million for the first quarter of 2018. As a percentage of total sales, selling expenses decreased to 14.4% for the first quarter of 2019 from 18.4% in the same quarter of 2018. The decrease in selling expenses is primarily due to a decrease in marketing and promotion expenses related to placenta polypeptide products, which is partly offset by increased selling expenses for plasma products.
General and administrative expenses in the first quarter of 2019 increased by $3.2 million, or 18.4%, to $20.6 million from $17.4 million in the same quarter of 2018. As a percentage of total sales, general and administrative expenses increased to 15.9% for the first quarter of 2019 from 15.5% for the same quarter of 2018. The increase in general and administrative expenses was mainly a combined result of the increased allowance for doubtful accounts receivable and increased depreciation expenses for the Company’s new facility in Shandong, which was partially offset by the decrease in share-based compensation expenses.
Research and development expenses in the first quarter of 2019 increased by $0.6 million, or 35.3%, to $2.3 million from $1.7 million in the same quarter of 2018. In the first quarter of 2019 and 2018, the Company received government grants totaling $0.4 million and $0.1 million, respectively, and the Company recognized them as a reduction of the research and development expenses. Excluding this impact, research and development expenses increased by $0.9 million for the first quarter of 2019 from the same quarter of 2018. As a percentage of total sales, research and development expenses, excluding the impact of these recognized government grants, increased to 2.1% for 2019 from 1.6% compared to the same quarter of 2018.
Income from operations in the first quarter of 2019 increased by 19.4% in RMB terms, or 12.8% in USD terms, to $44.0 million from $39.0 million in the same quarter of 2018. Operating margin decreased to 33.9% in the first quarter of 2019 from 34.7% in the first quarter of 2018.
Income tax expense in the first quarter of 2019 increased by $1.2 million, or 17.9%, to $7.9 million from $6.7 million in the same period of 2018. The effective income tax rate was 15.0% and 15.1% for the first quarter of 2019 and 2018, respectively.
Net incomeattributable to the Company increased by 26.5% in RMB terms, or 19.3% in USD terms, to $37.7 million in the first quarter of 2019 from $31.6 million in the same period of 2018. Net margin increased to 29.1% in the first quarter of 2019 from 28.1% in the same period of 2018. Diluted net earnings per share increased to $0.94 in the first quarter of 2019 compared to $0.92 in the same period of 2018.
Non-GAAP adjusted income from operations increased by 10.5% in RMB terms, or 4.2% in USD terms, to $52.2 million in the first quarter of 2019 from $50.1 million in the same period of 2018.
Non-GAAP adjusted net income attributable to the Company increased by 14.3% in RMB terms and 7.7% in USD terms, to $44.5 million in the first quarter of 2019 from $41.3 million in the same period of 2018. Non-GAAP net margin decreased to 34.3% in the first quarter of 2019 from 36.7% in the same period of 2018. Non-GAAP adjusted net income per diluted share decreased to $1.11 in the first quarter of 2019 from $1.21 in the same period of 2018.
Non-GAAP adjusted income from operations for the first quarter of 2019 excludes $6.3 million in non-cash employee share-based compensation expenses, and $2.1 million in amortization expense of intangible assets and land use rights related to the acquisition of TianXinFu.
Non-GAAP adjusted net income and diluted earnings per share for the first quarter of 2019 exclude $5.5 million in non-cash employee share-based compensation expenses, and $1.4 million in amortization expense of intangible assets and land use rights related to the acquisition of TianXinFu.
As of March 31, 2019, the Company had $99.0 million in cash on hand and demand deposits, $653.8 million in time deposits, and $171.2 million in short term investments.
Net cash provided by operating activities for the first quarter of 2019 was $32.2 million as compared to $23.3 million for the same period of 2018. The $8.9 million increase in net cash provided by operating activities was a combined result of the increase in both net income and non-cash expenses, which mainly include depreciation expenses and allowance for doubtful accounts receivable.
Accounts receivable increased by $11.6 million during the first quarter of 2019 as compared to $15.5 million during the same period of 2018. The accounts receivable turnover days for plasma products increased to 100 days during the first quarter of 2019 from 84 days during the same period of 2018, reflecting longer credit terms to hospitals as a result of the nationwide implementation of healthcare reform measures and intensified competition in the distributor channel.
Inventories increased by $4.0 million in the first quarter of 2019, which was milder than the increase of $10.8 million in the same period of 2018, mainly comprised of increased raw material plasma both out-sourced and from the Company’s own collection stations.
Net cash used in investing activities for the first quarter of 2019 was $214.7 million as compared to $135.5 million for the same period of 2018. During the first quarter of 2019, the Company paid $7.9 million for the acquisition of property, plant and equipment, intangible assets and land use rights, and the Company also purchased time deposits and short-term investments in the amount of $937.4 million. This was partly offset by $730.6 million from the maturity of time deposits and short term investments. Net cash used in investing activities in the first quarter of 2018 mainly consisted of $264.7 million payment for purchase of time deposits and short term investments, $11.3 million for the acquisition of property, plant and equipment, intangible assets, and land use rights, which was partly offset by $97.7 million cash received upon acquisition of TianXinFu and the maturity of $42.8 million time deposits and short term investments.
Net cash used in financing activities for the first quarter of 2019 was $60.0 million as compared to net cash provided by financing activities of $0.3 million for the same period of 2018. In the first quarter of 2019, $60.0 million was remitted to an investment bank by the Company to execute the previously approved share repurchase program on behalf of the Company. As of March 31, 2019, 415,356 shares had been repurchased at a total amount of $36.8 million with the remaining $23.2 million as down payment to the investment bank for further repurchases. Net cash provided by financing activities in the first quarter of 2018 represented proceeds of $0.3 million from stock options exercised.
Financial Outlook
The Company reiterates its forecast for the full year 2019. The company expects both non-GAAP adjusted income from operations and non-GAAP adjusted net income to increase by 4% to 6% in RMB terms over full year 2018 financial results.
This guidance does not factor in any potential foreign currency translation impact. Having previously adopted an exchange rate of approximately RMB6.59 = $1.00 based on weighted average quarterly exchange rates in 2018 in translating 2018 financial results, the Company expects that the total sales and non-GAAP adjusted net income in USD terms in 2019 could be affected by the foreign currency translation impact.
This guidance excludes potential acquisitions, and necessarily assumes no significant adverse product price changes during 2019. This forecast reflects the Company’s current and preliminary views, which are subject to change.
Conference Call
The Company will host a conference call at 7:30 am Eastern Time on May 13, 2019, which is 7:30 pm Beijing Time on May 13, 2019, to discuss its first quarter 2019 results and answer questions from investors. Listeners may access the call by dialing:
US:
1 888 346 8982
International:
1 412 902 4272
Hong Kong:
800 905 945
China:
400 120 1203
A telephone replay will be available one hour after the conclusion of the conference all through May 20, 2019. The dial-in details are:
US:
1 877 344 7529
International:
1 412 317 0088
Passcode:
10131286
A live and archived webcast of the conference call will be available through the Company’s investor relations website at http://chinabiologic.investorroom.com.
About China Biologic Products Holdings, Inc.
China Biologic Products Holdings, Inc. (NASDAQ: CBPO) is a leading fully integrated plasma-based biopharmaceutical company in China. The Company’s products are used as critical therapies during medical emergencies and for the prevention and treatment of life-threatening diseases and immune-deficiency related diseases. China Biologic is headquartered in Beijing and manufactures over 20 different dosage forms of plasma products through its indirect majority-owned subsidiary, Shandong Taibang Biological Products Co., Ltd. and its wholly owned subsidiary, Guizhou Taibang Biological Products Co., Ltd. The Company also has an equity investment in Xi’an Huitian Blood Products Co., Ltd. Since the acquisition of TianXinFu (Beijing) Medical Appliance Co., Ltd. in 2018, China Biologic is also engaged in the sale of medical devices, primarily regenerative medical biomaterial products. The Company sells its products to hospitals, distributors and other healthcare facilities in China. For additional information, please see the Company’s website www.chinabiologic.com.
Non-GAAP Disclosure
This news release contains non-GAAP financial measures that exclude non-cash compensation expenses related to options and restricted shares granted to employees and directors under the Company’s 2008 Equity Incentive Plan and amortization of acquired intangible assets and land use rights. To supplement the Company’s unaudited consolidated financial statements presented on a GAAP basis, the Company has provided non-GAAP financial information excluding the impact of these items in this release. The Company’s management believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. A reconciliation of the adjustments to GAAP results appears in the table accompanying this news release. This additional non-GAAP information is not meant to be considered in isolation or as a substitute for GAAP financials. The non-GAAP financial information that the Company provides also may differ from the non-GAAP information provided by other companies.
In addition, as the Company evaluates certain key items of its financial results on a local currency basis (i.e., in RMB) in addition to the reporting currency (i.e., in USD), this news release contains local currency information that eliminates the impact of fluctuations in foreign currency exchange rates. The Company believes that, given its operations primarily based in China, providing local currency information on such key items enhances the understanding of its financial results and evaluation of performance in comparison to prior periods. Changes in local currency percentages are calculated by comparing financial results denominated in RMB from period to period.
Safe Harbor Statement
This news release may contain certain “forward-looking statements” relating to the business of China Biologic Products Holdings, Inc. and its subsidiaries. All statements, other than statements of historical fact included herein, are “forward-looking statements.” These forward-looking statements are often identified by the use of forward-looking terminology such as “intend,” “believe,” “expect,” “are expected to,” “will,” or similar expressions, and involve known and unknown risks and uncertainties. Among other things, the management’s quotations and forecast of the Company’s financial performance in this news release contain forward-looking statements. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they involve assumptions, risks, and uncertainties, and these expectations may prove to be incorrect.
Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this news release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including, without limitation, quality of purchased source plasma, potential delay or failure to complete construction of new collection facilities, potential inability to pass government inspection and certification process for existing and new facilities, potential inability to achieve the designed collection capacities at the new collection facilities, potential inability to achieve the expected operating and financial performance, potential inability to find alternative sources of plasma, potential inability to increase production at permitted sites, potential inability to mitigate the financial consequences of a temporarily reduced raw plasma supply through cost cutting or other efficiencies, and potential additional regulatory restrictions on its operations and those additional risks and uncertainties discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website (http://www.sec.gov). All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.
Contact:
China Biologic Products Holdings, Inc. Mr. Ming Yin Senior Vice President Email: ir@chinabiologic.com
-XI(TM) Smart Raman provides revolutionary med-verification platform for the retail pharmacy supply chain
BEIJING, May 9, 2019 /PRNewswire/ — Artificial intelligence (AI) is pioneering a new wave of innovation in the medical industry prompting large healthcare providers to quickly implement AI to adapt to this technological revolution. AI has become a key strategic focal point for retail pharmacies, nursing, and other medical providers to upgrade their service delivery.
CloudMinds Partners with Retail Pharmacy Giant in U.S., Introducing Powerful Cloud AI Solution for Healthcare
CloudMinds provides a complete cloud-based AI solution for the medical industry, addressing unmet needs in the pharmacy retail market. For example, leading U.S. medicine distributors are implementing CloudMinds smart Raman spectrometers to support important supply chain activities including, incoming drug identification, drug sorting, quality control testing and recycling.
Smart Cloud Raman Spectrometer Addresses Unmet Needs in the Medical Retail Industry
Retail sales are a key component of the pharmacy supply chain. Government legislation in both the European and American medical industries has made retail pharmacy the most regulated and important endpoint in prescription drug sales. Pharmacies need to build a strong brand identity with their clients and can use the CloudMinds XI(TM) smart Raman spectrometer to ensure pharmacy dispensing accuracy and retention via better drug supply chain quality.
Independently developed by CloudMinds, the XI(TM) smart Raman spectrometer uses a patented optical design to improve collection efficiency, increase signal-to-noise ratio and reduced detection times. Through the use of lightweight, smart hardware, and AI technology applications, XI(TM) outperforms competitors, ensuring superior accuracy and reliability in drug identification. XI(TM) supports the detection of a mixture of up to three substances and achieves components recognition with ratios in 5 seconds or less, by leveraging deep learning AI for data training. This is a great improvement over the 6-30 second material matching time of traditional smart Raman spectrometers.
Pharmacy distribution and transmission generate massive amounts of data in their detection, sorting and recycling processes. CloudMinds XI(TM) quickly and accurately identifies the types of drugs being processed by leveraging a state-of-the-art cloud intelligence architecture, improving drug sorting and recycling efficiency in pharmacy retail stores. Store assistants can also get correct drug background information by a simple click on the XI(TM) interface, minimizing mistakes caused by manual sorting.
Unlike traditional solutions, the CloudMinds XI(TM) smart Raman spectrometer not only uses a local information database, but also leverages a large database in the cloud, giving it the ability to continuously update in real-time. The massive amount of drug testing data generated by each device is shared by the cloud brain, and AI algorithms in the cloud synchronize the drug information on each device. This ensures that each XI(TM) device in the supply chain has the same recognition capabilities. For large pharmacy retailers, this is critical, as it significantly reduces equipment maintenance costs and ensures service reliability.
Interest in the CloudMinds’ AI technology innovation has been keen. XI(TM) won the prestigious 2019 Prism Award in the category of sensors and detectors. The Prism Award recognizes outstanding examples of innovation and thought leadership in photonics research and development. CloudMinds has also signed an initial contract with a retailer giant for several hundred XI(TM) units worth over $4 million and has received strong interest from several other retailers. CloudMinds will continue to partner with large pharmacy retailers to expand the XI(TM) business and accelerate the technological transformation and development of the pharmacy retail industry.
