- Source : Press Release
- Date : 2019-09-30
- Companies : Biom'Up SA
Biom'up: Approval of 2019 H1 Interim Results Postponed: Board of Directors Pursues Review of Options Available to the Company
Saint-Priest, France, September 30, 2019 - 19h00 (CET) - Biom'up SA (the "Company"), specializing in surgical hemostasis, today announced that its Board of Directors resolved on September 27, 2019 to postpone the approval of the H1 interim results as it pursues the review of options available to the Company.
HEMOBLAST Bellows, launched in the United States in summer 2018, continues to penetrate the market with a very good level of acceptance by surgeons. The pace of average daily sales has continued to grow without interruption, as has been the case with monthly sales. Revenue increased from EUR0.6 million for the full year 2018 to EUR1.5 million for the first half of 2019 (compared to the unaudited figure of EUR1.4 million announced in early July) and is estimated at EUR2.5 million for the first nine months of 2019, in line with the announced revenue guidance of EUR4.0 to EUR4.5 million for 2019.
Despite these encouraging results, the cash position continues to deteriorate, linked to the increase in external charges and personnel expenses devoted to:
- sales and marketing expenses, namely for commercial development, particularly in the United States;
- R&D expenditures, notably pre-clinical studies necessary to obtain approval of HEMOBLAST Bellows for spine surgery and preparation for the IDE (Investigational Device Exemption) application necessary for obtaining the market authorization for HEMOSNOW in the US;
- general and administrative expenses linked to the growth of the Company's operations in the United States.
Unaudited consolidated cash at end of September 2019 is estimated at EUR4.5 million compared to EUR8.5 million at end of June while the Company raised a third tranche of EUR5.0 million in early August 2019 from the up to EUR35.0 million bond credit facility entered into in March 2018 with Athyrium. As of today, the Company issued EUR33.0 million of bonds in this context; the outstanding EUR2.0 million remaining subject to Athyrium's appoval.
Based on the cash position at the end of September, the Company maintains its anticipation of a cash shortfall from the beginning of November 2019. This estimate is based notably on the assumption of receiving the 2018 Research Tax Credit in the amount of EUR1 million in October 2019.
In addition, the Company considers that starting from October 2019, it will not be able to meet its covenant vis-à-vis Athyrium in connection with the bond financing agreement entered into with the latter to maintain a minimum cash position equal to EUR2 million until August 10, 2020 (then EUR8 million until the end of the contract). Should this minimum liquidity ratio not be respected, the interest rate on the bonds would be increased from 10% to 13% per annum and the bondholders' representative may decide to render immediately repayment of all amounts owed under the bonds subscribed by Athyrium.
The Board of Directors continues to examine all options available to date. Given the uncertainty of obtaining new sources of financing and the consequences of not meeting the minimum cash covenant vis-à-vis Athyrium, the H1 interim results will not be approved by the Board of Directors on the basis of the going concern principle until one of such options materializes. Accordingly, the Board of Directors decided to postpone to a later date the approval of the H1 interim results.
Separately, Mr. Karl Nägler, a director since 2015, indicated to the Board of Directors his decision to no longer pursue his mandate beyond September 27, 2019 and resigned as of such date. The Board of Directors, now comprised of the Chairman and four independent directors, wishes to thank Mr. Nägler for his years of service and active contributions to the Company's strategic development.
Chief Financial Officer
33 4 86 57 36 10
|MC Services AG
Internationale Public & Investor Relations
49 211 529252-22
Founded in 2005 and based in the Lyon suburb of Saint-Priest (France), Biom'up develops and commercializes hemostatic products based on patented biopolymers designed to simplify the surgeons practices for open and minimally invasive surgical procedures, including laparoscopic, in multiple specialties such as cardiac, general, and orthopedic surgery. The Company's lead product, HEMOBLASTTM Bellows and its laparoscopic applicator are marketed in Europe and the United States.About HEMOBLAST
HEMOBLAST Bellows is a hemostatic product to control bleeding in a broad range of open and minimally invasive surgical procedures including laparoscopy for multiple specialties such as cardiac, general, and orthopedic surgery.
Uncontrolled bleeding is a major surgical complication associated with higher mortality, longer hospitalization and higher rates of transfusions and reoperations. Beyond its impact on patient's health, this major complication causes excess costs in all surgical specialties and is a burden for hospital budgets across the globe. HEMOBLAST Bellows is the only surgical hemostatic agent approved by the FDA based on the validated SPOT GRADE(TM) Surface Bleeding Severity Scale (SBSS), which demonstrates the ability to control a range of bleeding from minimal (oozing), mild (pooling) and moderate (flowing) bleeding. HEMOBLAST Bellows is proven to control bleeding with flow rates up to 117 mL per minute. Due to its efficacy, versatility and ease of use, HEMOBLAST Bellows is quickly becoming a popular choice amongst U.S. surgeons looking for new options to control surgical bleeding challenges.
Biom'up obtained CE Marking for HEMOBLAST Bellows in December 2016. On the basis of compelling preliminary results (93% effectiveness at 6 minutes, compared with 74% for the control arm) in a major clinical trial, FDA approval for HEMOBLAST Bellows in December 2017, seven months ahead of the original plan. This allowed for the commercial roll-out of its lead product in the U.S. in the summer of 2018.
In July 2018, Biom'up additionally obtained CE Marking for its HEMOBLAST Bellows Laparoscopic Applicator designed to deliver the HEMOBLAST Bellows powder in all minimally-invasive procedures. In January 2019, the Company obtained the respective approval for HEMOBLAST Bellows Laparoscopic Applicator in the U.S. This has opened up new market segments, representing approximately 500,000 and 443,000 surgeries per year in Europe and the US respectively.
Currently the Company is working to expand the range of applications for HEMOBLAST Bellows. In addition, the approval from the Australian health authorities for the Company's lead product is expected during the second half of 2019.
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