Peijia Medical Announces 2021 Interim Results


Peijia Medical Announces 2021 Interim Results

TAVR products TaurusOne® and TaurusElite® launched to market
Robust growth on neurointerventional business
Building a global R&D platform

 

[Hong Kong, August 30, 2021] Peijia Medical Limited (“Peijia Medical” or the “Company”, together with its subsidiaries, the “Group”, stock code: 9996), a leading domestic player in the high-growth transcatheter valve therapeutic and neurointerventional procedural medical device markets in China, announced its interim results for the six months ended June 30, 2021 (the “Period”).

During the period, the Group recorded a revenue of RMB51.69 million, representing an increase of 263.0% as compared to the corresponding period of 2020. Gross profit was RMB37.40 million, representing a substantial increase of 317.7% as compared to the corresponding period of 2020, while gross profit margin increased to 72.4%. Peijia Medical has a comprehensive product pipeline, leading the transcatheter valve therapeutic medical device market and the neurointerventional procedural medical device market in China. During the six months ended June 30, 2021, the Group obtained registration approvals from the National Medical Products Administration (“NMPA”) for seven products including TaurusOne® and TaurusElite®. As of June 30, 2021, the Group had 15 registered products and 14 product candidates at various development stages.

R&D is about to pay off

The Group’s heart valve business focuses on treating the most prevalent valvular heart diseases, including aortic stenosis, mitral regurgitation, tricuspid regurgitation, and heart valve calcification, via transcatheter approaches. TaurusOne®, the Group’s in-house developed first-generation transcatheter aortic valve replacement (“TAVR”) product, is designed to treat aortic valve stenosis using a catheter-based approach. The Group received the NMPA approval for TaurusOne® in April, 2021, and commercialized it shortly afterwards in May, 2021. During the period, the Group’s revenue generated from the sales of TaurusOne® amounted to RMB9.38 million.

The Group has always been committed to technological R&D and product enhancement. Its second-generation TAVR product, TaurusElite®, features a key upgrade in its DCS that allows physicians and surgeons to retrieve and reposition the PAV if the initial release position is not ideal, further improving the safety of the TAVR procedure. The Group received the NMPA approval for TaurusElite® in June, 2021. TaurusElite® is the second retrievable TAVR product that obtained NMPA approval. The Group has successfully launched TaurusElite® to the market by August 30, 2021, after the Reporting Period.

The third-generation TAVR product, TaurusNXT®, adopts the Group’s patented anti-calcification technology and a low-temperature freeze-drying technology, which are expected to greatly enhance the durability and biocompatibility of the PAV and maintain the physical integrity of the valve tissue. The Group expects to start the patient enrollment process for the clinical trial of TaurusNXT® in the third quarter of 2021.

The Group achieved multiple collaborations with its global partners regarding transcatheter mitral valve (“TMV”) and transcatheter tricuspid valve (“TTV”) replacement and repair products. the Group entered into a license agreement with HighLife SAS (“HighLife”), a French-based medical device company. Pursuant to the agreement, the Group is entitled to, among other things, manufacture, develop, and commercialize the HighLife TMV replacement device in the Greater China region. As of June 30, 2021, HighLife had initiated the clinical studies of its TMVR in Europe and Australia. The Group is currently in the process of technology transfer and expects to start the feasibility clinical trial in China for this product in the fourth quarter of 2021.

The Group also entered into a stock purchase agreement with Sutra Medical, Inc (“Sutra”), a US-based medical device company that designs and develops transcatheter solutions to treat valvular heart diseases. Sutra will share the R&D facilities with the Group’s R&D center in the United States, and will also assist the Group in expanding R&D presence in North America. Besides the collaborations with its global partners, the Group has also been developing a transapical TMV replacement device and a transeptal TMV repair clip in-house. Both products are currently in pre-clinical stage.

Moreover, the Group has partnered with inQB8 Medical Technologies, LLC (“inQB8”), a US-based medical technology incubator, to explore innovative solutions for treating structural heart diseases. The partnership includes the Group’s acquisition of a TTVR technology from inQB8, which is currently in the animal studies stage, and for which inQB8 will continue with device development in partnership with the Group.

For neurointerventional procedural products, Peijia Medical currently has a comprehensive portfolio of commercialized and pipeline products that target both hemorrhagic and ischemic stroke areas. During the Period, the Group’s revenue generated from the sales of neurointerventional products amounted to RMB42.31 million, representing an increase of 197.13% as compared to the corresponding period of 2020. The Group received the NMPA approval for the Jasper® SS Detachable Coil in June 2021, making it the Group’s third NMPA approved detachable coil. The Group also received the NMPA approval for Heralder® Distal Access Catheter in June, 2021, and expects to commercialize this product in the third quarter of 2021. In addition, the Group has submitted the NMPA registration application for Shenyi® Stent Retriever, a major product candidate of the Group, and currently expects to obtain the approval in the second quarter of 2022.

Strong R&D team and robust intellectual property portfolio

Peijia Medical has robust in-house R&D capabilities. R&D team leaders are industry veterans with impressive academic and professional backgrounds, having previously worked in managerial positions at various leading players in the medical device sector. As of June 30, 2021, the Group had an in-house R&D team of 73 employees dedicated to the research and development of its transcatheter valve therapeutic products and neurointerventional procedural products. Meanwhile, the Group had a robust intellectual property portfolio, consisting of a total of 60 registered patents and 75 patents under application.

Optimizes the deployment of commercialization

As of June 30, 2021, the Group had an expanded sales and marketing team of 85 full-time employees, with 43 of whom dedicated to the sales and marketing of Neurointerventional products and 42 focusing on the sales and marketing of Transcatheter Valve Therapeutic devices. For heart valve business, the Group has built an in-house sales and marketing team with professional background and experience in the innovative medical device industry, focusing on the market education and academic promotions of its TAVR products. The Group commercialized TaurusElite® in July, 2021, after the Reporting Period and not long after it obtained NMPA registration approval in June, 2021.

Dr. Yi Zhang, Executive Director, Chairman of the Board and Chief Executive Officer of Peijia Medical Limited, said “Peijia Medical is committed to becoming a world-class medical device leader rooted in China. By implementing of a series of future strategies and plans, we will strive to strengthen the Group’s leading position in the industry. Looking forward, we will expedite the R&D of products, accelerate the commerciallization of product candidates and enhance the collaborations with global partners to reciprocate patients with quality products.”

- End -

About Peijia Medical Limited
Peijia Medical Limited is a leading domestic player in each of the transcatheter valve therapeutic medical device market and neurointerventional procedural medical device market in China. It focuses on the high-growth interventional procedural medical device market in China and globally. Peijia Medical has built a synergetic platform encompassing research and development, manufacturing and commercialization capabilities as well as a comprehensive product portfolio. Reverence for life, perseverance on innovation: Peijia Medical is committed to become a world-renowned medical device company that provides total treatment solutions for structural heart and neurovascular diseases.

Peijia Medical Announces 2021 Interim Results

TAVR products TaurusOne® and TaurusElite® launched to market
Robust growth on neurointerventional business
Building a global R&D platform

 

[Hong Kong, August 30, 2021] Peijia Medical Limited (“Peijia Medical” or the “Company”, together with its subsidiaries, the “Group”, stock code: 9996), a leading domestic player in the high-growth transcatheter valve therapeutic and neurointerventional procedural medical device markets in China, announced its interim results for the six months ended June 30, 2021 (the “Period”).

During the period, the Group recorded a revenue of RMB51.69 million, representing an increase of 263.0% as compared to the corresponding period of 2020. Gross profit was RMB37.40 million, representing a substantial increase of 317.7% as compared to the corresponding period of 2020, while gross profit margin increased to 72.4%. Peijia Medical has a comprehensive product pipeline, leading the transcatheter valve therapeutic medical device market and the neurointerventional procedural medical device market in China. During the six months ended June 30, 2021, the Group obtained registration approvals from the National Medical Products Administration (“NMPA”) for seven products including TaurusOne® and TaurusElite®. As of June 30, 2021, the Group had 15 registered products and 14 product candidates at various development stages.

R&D is about to pay off

The Group’s heart valve business focuses on treating the most prevalent valvular heart diseases, including aortic stenosis, mitral regurgitation, tricuspid regurgitation, and heart valve calcification, via transcatheter approaches. TaurusOne®, the Group’s in-house developed first-generation transcatheter aortic valve replacement (“TAVR”) product, is designed to treat aortic valve stenosis using a catheter-based approach. The Group received the NMPA approval for TaurusOne® in April, 2021, and commercialized it shortly afterwards in May, 2021. During the period, the Group’s revenue generated from the sales of TaurusOne® amounted to RMB9.38 million.

The Group has always been committed to technological R&D and product enhancement. Its second-generation TAVR product, TaurusElite®, features a key upgrade in its DCS that allows physicians and surgeons to retrieve and reposition the PAV if the initial release position is not ideal, further improving the safety of the TAVR procedure. The Group received the NMPA approval for TaurusElite® in June, 2021. TaurusElite® is the second retrievable TAVR product that obtained NMPA approval. The Group has successfully launched TaurusElite® to the market by August 30, 2021, after the Reporting Period.

The third-generation TAVR product, TaurusNXT®, adopts the Group’s patented anti-calcification technology and a low-temperature freeze-drying technology, which are expected to greatly enhance the durability and biocompatibility of the PAV and maintain the physical integrity of the valve tissue. The Group expects to start the patient enrollment process for the clinical trial of TaurusNXT® in the third quarter of 2021.

The Group achieved multiple collaborations with its global partners regarding transcatheter mitral valve (“TMV”) and transcatheter tricuspid valve (“TTV”) replacement and repair products. the Group entered into a license agreement with HighLife SAS (“HighLife”), a French-based medical device company. Pursuant to the agreement, the Group is entitled to, among other things, manufacture, develop, and commercialize the HighLife TMV replacement device in the Greater China region. As of June 30, 2021, HighLife had initiated the clinical studies of its TMVR in Europe and Australia. The Group is currently in the process of technology transfer and expects to start the feasibility clinical trial in China for this product in the fourth quarter of 2021.

The Group also entered into a stock purchase agreement with Sutra Medical, Inc (“Sutra”), a US-based medical device company that designs and develops transcatheter solutions to treat valvular heart diseases. Sutra will share the R&D facilities with the Group’s R&D center in the United States, and will also assist the Group in expanding R&D presence in North America. Besides the collaborations with its global partners, the Group has also been developing a transapical TMV replacement device and a transeptal TMV repair clip in-house. Both products are currently in pre-clinical stage.

Moreover, the Group has partnered with inQB8 Medical Technologies, LLC (“inQB8”), a US-based medical technology incubator, to explore innovative solutions for treating structural heart diseases. The partnership includes the Group’s acquisition of a TTVR technology from inQB8, which is currently in the animal studies stage, and for which inQB8 will continue with device development in partnership with the Group.

For neurointerventional procedural products, Peijia Medical currently has a comprehensive portfolio of commercialized and pipeline products that target both hemorrhagic and ischemic stroke areas. During the Period, the Group’s revenue generated from the sales of neurointerventional products amounted to RMB42.31 million, representing an increase of 197.13% as compared to the corresponding period of 2020. The Group received the NMPA approval for the Jasper® SS Detachable Coil in June 2021, making it the Group’s third NMPA approved detachable coil. The Group also received the NMPA approval for Heralder® Distal Access Catheter in June, 2021, and expects to commercialize this product in the third quarter of 2021. In addition, the Group has submitted the NMPA registration application for Shenyi® Stent Retriever, a major product candidate of the Group, and currently expects to obtain the approval in the second quarter of 2022.

Strong R&D team and robust intellectual property portfolio

Peijia Medical has robust in-house R&D capabilities. R&D team leaders are industry veterans with impressive academic and professional backgrounds, having previously worked in managerial positions at various leading players in the medical device sector. As of June 30, 2021, the Group had an in-house R&D team of 73 employees dedicated to the research and development of its transcatheter valve therapeutic products and neurointerventional procedural products. Meanwhile, the Group had a robust intellectual property portfolio, consisting of a total of 60 registered patents and 75 patents under application.

Optimizes the deployment of commercialization

As of June 30, 2021, the Group had an expanded sales and marketing team of 85 full-time employees, with 43 of whom dedicated to the sales and marketing of Neurointerventional products and 42 focusing on the sales and marketing of Transcatheter Valve Therapeutic devices. For heart valve business, the Group has built an in-house sales and marketing team with professional background and experience in the innovative medical device industry, focusing on the market education and academic promotions of its TAVR products. The Group commercialized TaurusElite® in July, 2021, after the Reporting Period and not long after it obtained NMPA registration approval in June, 2021.

Dr. Yi Zhang, Executive Director, Chairman of the Board and Chief Executive Officer of Peijia Medical Limited, said “Peijia Medical is committed to becoming a world-class medical device leader rooted in China. By implementing of a series of future strategies and plans, we will strive to strengthen the Group’s leading position in the industry. Looking forward, we will expedite the R&D of products, accelerate the commerciallization of product candidates and enhance the collaborations with global partners to reciprocate patients with quality products.”

- End -

About Peijia Medical Limited
Peijia Medical Limited is a leading domestic player in each of the transcatheter valve therapeutic medical device market and neurointerventional procedural medical device market in China. It focuses on the high-growth interventional procedural medical device market in China and globally. Peijia Medical has built a synergetic platform encompassing research and development, manufacturing and commercialization capabilities as well as a comprehensive product portfolio. Reverence for life, perseverance on innovation: Peijia Medical is committed to become a world-renowned medical device company that provides total treatment solutions for structural heart and neurovascular diseases.