Shanghai, China, 30 August 2022 - MicroPort Scientific Corporation (“MicroPort®” or the “Group”) today announced the interim results of the Group and its subsidiaries for the six months ended 30 June 2022 (the "Reporting Period").
In the first half of 2022, the Group continued to maintain stable business operations and steady development, and achieved global business revenue of US$405.0 million, representing an increase of 10.1% compared to the corresponding period last year. Within this, the heart valve business, the endovascular and peripheral vascular devices business, and the neurovascular devices business recorded increase of 44.8%, 26.6% and 22.9% in revenue respectively, mainly attributable to the rapid market penetration and the revenue contributed from new products. Meanwhile, the overseas revenue of the CRM business, the orthopedics devices business and the cardiovascular devices business recorded steady growth of 8.1%, 9.7%, and 28.1% respectively.
During the reporting period, in the face of the sudden outbreak of the omicron variant of COVID-19 in Shanghai and other cities, the Group made full use of the platform advantages of a globalized supply chain and full business coverage, ensuring the continuous operation of the production bases and the supply of core products, which demonstrated its commitment to social responsibility and caring for people’s livelihood with its principle of “patients come first”. The Group is committed to continuously bringing innovation, techonology and services to patients around the world, and building a global leading medical devices group in the high-tech medical field.
Market share of most established business segments increased significantly in China
During the reporting period, with the expiration of the first-year agreement of the national centralized volume-based procurement (“VBP”) on coronary stents, the Chinese government organized the renewal of the second-year procurement contract. The cumulative renewed procurement volume of the Group’s two bid-winning products, Firebird2® Rapamycin Eluting Coronary CoCr Stent System (“Firebird2®”) and Firekingfisher™ Rapamycin Eluting Coronary CoCr Stent System (“Firekingfisher™”), increased significantly compared to the first year’s procurement volume. With the support of the large-scale digitalized production and supply chain capacity, the Group will continue to fulfill its commitment of product supply, ensuring both quality and quantity. While fully undertaking its social responsibilities and satisfying patients’ needs, MicroPort® is expected to further expand its market share and penetration rate in the cardiovascular interventional treatment area. At the end of the reporting period, its drug eluting stent products have covered over 3,000 hospitals nationwide in China.
Through the creation of a differentiated product portfolio for CRM business, the Group’s various types of dual-chamber pacemakers have successfully won the bids in provincial and inter-provincial alliance VBPs, bringing in a significant increase in market share and penetration rate. The pacemaker products have already covered approximately 1,000 hospitals in China. However, despite the challenges brought on by the pandemic, MicroPort® overcame all the obstacles and successfully promoted the Rega®, the first and currently the only Chinese-developed MRI-conditional implantable pacemaker to be approved by the National Medical Products Administration (“NMPA”). With the full launch of MRI-compatible pacemakers, the competitiveness and influence of this business segment will continue to grow, substantially solidifying our leading position with the largest market share among domestic players.
The endovascular and peripheral vascular devices business achieved a revenue of approximately US$70.8 million, representing an increase of 26.6% compared to the corresponding period of last year, which was driven by the accelerated market penetration of innovative products approved and launched in recent years, and especially the strengthening of the distribution channels in the primary market. The Castor™ Branched Aortic Stent-Graft System (“Castor™”), the world’s first branched aortic stent-graft and delivery system, has achieved steady growth in sales, and has penetrated more than 750 hospitals across the country, with over 12,000 implantations completed from its launch to the end of the reporting period.
The Group has actively taken all kinds of countermeasures to maintain its production and operation, as well as putting efforts into the development of overseas markets, which partially offset the aforementioned negative impact. During the reporting period, the neurovascular devices business recorded a revenue of US$31.3 million, representing a significant increase of 22.9% compared to the corresponding period of last year. In addition, the Group’s NUMEN™ series of coil products won the VBP bids in Hebei Province, Jiangsu Province and Fujian Province, which will significantly shorten the time for hospital admission, and is expected to achieve a major breakthrough in the market share.
During the reporting period, the heart valve business recorded a revenue of approximately US$19.0 million, representing an increase of 44.8% compared to the corresponding period of last year, and the gross profit margin of this business segment recorded a substantial year-on-year rise of 8.5 percentage points to 63.7%. The Group has accelerated the integration of its advantageous resources in the pan-cardiac treatment field to further promote the penetration of its innovative transcatheter solutions for structural heart diseases to the grassroot regions through medical education and marketing activities. At the reporting date, the VitaFlow® Transcatheter Aortic Valve Implantations and Delivery System (“VitaFlow®”) and VitaFlow Liberty™ Transcatheter Aortic Valve Implantations and Retrievable Delivery System (“VitaFlow Liberty™”) products have newly penetrated more than 80 hospitals across the country, with a cumulative penetration of over 390 hospitals and a leading marketing share in over 230 hospitals therein.
Global exploration moved forward steadily
Through its diversified sales model, the Group continued to cultivate mature markets and explore emerging markets.
During the reporting period, the MicroPort® cardiovascular devices business segment recorded overseas revenue of approximately US$9.9 million, representing an increase of approximately 28.1% compared to the corresponding period of last year. In the Indian market, which sees the third largest number of percutaneous coronary intervention operations in the world, the effect of the multi-product portfolio strategy since the Group successfully launched Firehawk IN™ as its first locally-manufactured coronary stent in an overseas market has gradually shown a significant increase in sales revenue. In Europe, with the support of the abundant clinical data from the Firehawk® TARGET series, the Group’s coronary stent products have been successfully admitted into the government tender or medical insurance negotiation frameworks in France, Italy and Portugal, driving a steady grow in the market share.
During the reporting period, the international (non-China) orthopedics business recorded a revenue of US$99.7 million, representing an increase of 9.7% compared to the corresponding period of last year. In Europe, the Middle East and Africa (“EMEA”), one of its major direct sales markets, through continuous channel development and medical education promotion, the Group recorded a significant year-on-year increase of 32.3% in revenue during the reporting period, which is much higher than the average rate of the market average growth.
The international (non-China) CRM business recorded a revenue of US$98.9 million, representing an increase of 8.1% compared to the corresponding period of last year, among which the United States, Japan and EMEA have recorded a year-on-year growth in revenue of 51.7%, 41.0% and 5.0% respectively. In terms of product coverage, the new generation of pacemakers and home monitors, which are equipped with Bluetooth® technology, has been widely recognized by local clinicians and patients for its convenient remote monitoring functions since its launch in Europe and Japan, driving the rapid growth in sales of pacemakers.
At the end of the reporting period, the sales of the endovascular and peripheral vascular devices business segment had covered 21 countries and regions across Europe, Latin America and South Asia, and achieved significant breakthroughs in product implantation in European markets such as Germany and Poland. During the reporting period, the Hyperflex™ Balloon Dilation Catheter has been approved for launch in Japan, marking the debut in the Japanese market for this business segment and laying a solid foundation for further exploration in the Asian and even the global market. In addition, the Reewarm™ PTX Drug Balloon Dilation Catheter received registration approval in Brazil, and the first commercial implantation of the Hercules™ Low Profile Aneurysm and Delivery System was completed in India. In July 2022, the Castor™ Branched Aortic Stent-Graft System was approved for customized distribution in Europe.
In addition, significant progress was achieved in the globalization of the neurovascular devices business, the heart valve business, and the surgical robot business. The NUMEN™ Coil has completed multiple commercial implantations in Korea, the United States and several European countries, and was approved for marketing in Brazil and Japan, while the APOLLO™ Intracranial Arterial Stent System has generated sales in Brazil for the first time. Moreover, since the launch of the VitaFlow® product series in Argentina, multiple commercial implantations have been successfully completed in more than 20 local hospitals. At the same time, the Group is actively pursuing registration approvals for the second generation TAVI product, VitaFlow Liberty™, in multiple regions including Europe, India, Brazil and Korea, and the product was successfully registered in Colombia. The Honghu Orthopedic Surgical Robot obtained 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) in July 2022, becoming the first and the only Chinese surgical robot cleared by the FDA to date.
R&D projects achieved fruitful results
During the reporting period, the R&D projects of the Group achieved fruitful results. From the beginning of 2022 to the date of this announcement, the Group and its associated companies have had 14 products obtain the Class III initial registration certificates from the NMPA, and have obtained FDA clearance for 5 products and CE Marking for 5 products. Meanwhile, our self-developed product, the prostatic urethral lift system, was newly admitted in the Green Path. At the date of this announcement, the Group and its associated companies had a total of 26 products being approved to enter the Green Path, ranking them first in the medical device industry for seven consecutive years.
As for the cardiovascular devices business, the registration application of the self-developed anchor balloon has been submitted to the NMPA, and MicroPort® has completed the first patient enrollment in the pre-marketing clinical trial of the coronary rapamycin drug-coated balloon catheter on the treatment of primary coronary bifurcation lesions. In terms of active interventional products, the pre-marketing clinical trial of the rotational atherectomy system on the treatment of coronary artery calcification has completed the first patient enrollment, signifying that the first Chinese-developed rotational atherectomy system has officially entered the clinical stage, providing a new option for clinical interventional treatment of coronary artery calcification lesions, especially for moderate to severe calcification.
In the CRM business, the Invicta™ Defibrillation Lead compatible to 1.5T and 3T magnetic resonance imaging (“MRI”) obtained the CE Marking ahead of schedule and became a major breakthrough in our brand new product series of implantable defibrillation systems. In addition, the Group is developing a new generation of Implantable Cardioverter Defibrillators and Cardiac Resynchronisation Therapy and Defibrillation equipped with Bluetooth® technology.
In the heart valve business, during the reporting period the Group released the results of the five-year follow-up data for the clinical study of VitaFlow®. The post-operation five-year survival rate is 81.8%, with a significant improvement in quality of life after surgery. The excellent clinical data will establish a solid evidence base for the global expansion of the VitaFlow® series of products. The MicroPort® self-developed TMV product has completed first-in-man (FIM) trial in July 2022, with excellent 30-day follow-up results after surgery. The system is the first of its kind to use a self-developed unique anti-calcification and dry valve treatment technique to further improve the durability of prosthetic valves, making it the world’s first dry-tissue transcatheter mitral valve replacement system with clinical application.
As for the neurovascular devices business, a total of four self-developed products were approved by the NMPA during the reporting period, and the commercialized product portfolio has covered three major areas of neurovascular diseases. The world’s first adjustable fully-visualised Thrombectomy Stent Tigertriever® (“Tigertriever®”), for which we act as the exclusive distributor of Rapid Medical in Greater China, is at the NMPA registration stage. In addition, another flagship product of Rapid Medical, the Tigertriever®13 Distal Access Thrombectomy Device (“Tigertriever®13”), for which we have exclusive distribution right in Greater China, received FDA clearance in July 2022. Tigertriever®13 is compatible with smaller microcatheters for safe access to remote lesion locations, making it the world’s smallest thrombectomy stent to date.
At the date of this announcement, the Toumai® Laparoscopic Surgical Robot (“Toumai®”) has completed all enrolled surgeries in the multidisciplinary and multicenter registrational clinical trials, and the application for registration has been submitted to NMPA for the expansion of its multi-disciplinary application, making Toumai® the second laparoscopic surgical robot in the world, and the first of its kind in China that can cover important and complex procedures in the thoracic, abdominal and pelvic cavities (urology and gynecology). In addition, the Trans-bronchial Surgical Robot has completed the first-in-man (FIM) trial of transbronchial robotic lung biopsy, which is also a breakthrough achieved by a Chinese-developed surgical robot in the field of non-invasive natural cavity surgery.
Emerging business segments flourished
While actively promoting the steady development of its established business segments, the Group is also exploring emerging business field including urology, respiration, digestion,gynecology, medical imaging, rehabilitation treatment, and sports medicine.
In the field of urology, respiration, digestion and gynecology, during the reporting period the Group’s two major products, namely the single-use flexible digital ureteroscope catheter and the single-use hemostatic clip device, were approved by the NMPA for launch in China, and five new products were approved for marketing in Brazil and Thailand. The “Green Path” product, the prostatic urethral lift system, has completed the first-in-man (FIM) clinical trial and is preparing for the registration clinical trial.
As for the field of medical imaging, the Group launched the MicroPort Argus™ intravascular optical coherence tomography system, the only purge-free disposable imaging catheter in China, which has achieved a rapid market introduction, and realized the first batch of commercial sales by leveraging our existing channel resources. For rehabilitation treatment, the TherMotion™ Cryo-Thermo Compression Device has received the registration certificate in China. In sports medicine, the multicenter registrational clinical trial for Archimedes™, the world’s first long-term implantable balloon rotator cuff system, is close to completion, with accomplishment of its FDA pre-submission. The 4K high-resolution arthroscope system, suture anchor series and suspension device system are in the registration process.