Neumarkt, Düsseldorf, Germany; 8 March 2019 – Bionorica SE has some special research outcomes to report alongside its record-breaking sales and recruitment figures for 2018. The market leader in scientifically researched natural medicines in Germany and other pharmaceutical markets has proven in an internationally published clinical trial(1) that its herbal medicine Canephron® is not inferior to an antibiotic for the treatment of uncomplicated urinary tract infections(2). Urinary tract infections (UTIs) are one of the most common medical conditions, particularly in women. Acute, uncomplicated UTI has been the second most common reason for prescribing antibiotics(3) in the outpatient sector yet. “Our research results represent a major breakthrough, because we offer patients an effective plant-based alternative that is evidence-based and acknowledged. We are therefore showing how prescriptions of antibiotics for UTIs can be reduced,” said Professor Michael A. Popp, CEO of Bionorica SE at the company’s annual results press conference.
Strong increase in demand for Dronabinol
A further milestone for Bionorica, which is based in Bavaria and operates worldwide on the basis of a unique research and manufacturing philosophy (Phytoneering), has been the significantly higher demand in the last year from critically ill patients for the company’s product Dronabinol, an active ingredient from the cannabis plant. Doctors are prescribing Dronabinol above all to relieve chronic pain in patients who have no alternative treatment options. So in the last year, in Germany alone, Bionorica supplied around 19,500 patients with the THC-based prescription-only medicine, an increase of 85% over the previous year(4). In 2018, Bionorica made the cannabinoid available to almost 11,000 patients in Austria, Denmark and Switzerland. “We made losses with Dronabinal for over a decade, due to the limited market, non-reimbursement by health insurers and the R&D costs involved. Nevertheless, we have continued to invest and stay in the market for the sake of the many critically ill people who have exhausted all other treatment options,” says Professor Popp, reinforcing his commitment to patients.
Record sales year after year
Overall, Bionorica, which has won various awards for its innovations and strong growth, enjoyed yet another record-breaking result in the last fiscal year. In 2018, the Bionorica Group’s sales increased to nearly EUR 338 million, up around 13.8 percent on the previous year(5). This means that Bionorica Group has been able to increase sales fivefold in the last 15 years.
Market leadership extended in Germany
In Germany, pharmacists sold more than 20 million units(6) of the market leader’s products for the first time last year, mainly Sinupret®, Bronchipret® and Imupret®. Sales of Canephron®, which has become the No. 1 medication in the market for herbal urologicals, were also up. The cold preparation Sinupret® had a market share of 62.5 percent(7) in the sinusitis market in Germany in 2018. On the basis of its sales figures in euros, Bionorica was once again identified as one of the most dynamic companies in the OTC sector in Germany.
Exports significantly up, more jobs created in Germany and other countries
The Bavarian company enjoyed similar successes in markets in Austria, Poland, Russia and other countries. “In Austria, pharmacists sold 8.2 percent(8) more units than in the previous year. In Poland we grew by 18.5 percent(9) compared to our direct competitors,” says Dr Uwe Baumann, Head of Global Business and Member of the Executive Board at Bionorica, about the company’s success story. In Russia, Sinupret®, Canephron® and the gynaecological phytotherapeutic preparation Mastodynon® are among the products most prescribed by doctors in their segment and were able to win additional market shares(10). In total, Bionorica exported 45 million units overseas last year, an increase of 15.4 percent(11) on 2017. The company, which has invested heavily in its research and high-tech production facilities in Neumarkt, recruited more staff again in 2018, an increase in headcount of 6.2 percent(12). Of the 1,700 people employed by Bionorica worldwide, more than 1,000 work in Germany.
Huge potential: Major EU countries open their doors to Bionorica
To be able to significantly increase the contribution margins for R&D, Bionorica wants to grow continuously using its own financial resources. The forecasts for the sustainably operating company are regarded as excellent. In this context, the current success of Bionorica in obtaining marketing authorisations in several EU countries, that in the past have tended to be protectionist, offers tremendous potential. For example, Bionorica was able to get approval for two herbal medicines(13) in the Italian market, which is dominated by prescription-only medicines and dietary supplements. It also obtained marketing authorisations in France and Spain. Marketing authorisations for other preparations are set to be granted in these EU countries in the course of the year. Moreover, Bionorica is stepping up its activities in Mexico, the second-largest market in Latin America. Within the next 12 months, the company wants to introduce phyto-pharmaceutical products in Mexico from the respiratory, gynaecological and urological segments. Bionorica also sees further potential for Dronabinol in Germany and other countries. In Germany alone, there are a large number of patients with very severe and in some cases chronic illnesses, who have not received successful treatment so far and who could benefit from THC.
Sources:
(1) CanUTI-7 trial https://www.karger.com/Article/FullText/493368
(2) Acute, uncomplicated UTIs
(3) DAZonline, “Multimodale Phytotherapie bei Blasenentzündung”, 27.6.2017, https://www.deutsche-apotheker-zeitung.de/online-inhalte/e-learning/bionorica/multimodale-phytotherapie-bei-blasenentzuendung/chapter:allBlasenentz%C3%BCndungen (as of 1 March 2019)
(4) Insight Health ApoFusion, pharmacy sell-in
(5) Bionorica SAP BW (business warehouse), 2017: EUR 296.9 million sales, 2018: EUR 337.9* million sales of Bionorica Group (*2018 figures provisional, subject to confirmation by auditors)
(6) Insight Health ApoFusion (pharmacy sell-out sales in units): 20.3 million units in 2018
(7) Insight Health ApoFusion (pharmacy sell-out sales in units in the sinusitis market)
(8) Iqvia, pharmacy sell-out sales in units
(9) Pharma Sequence, pharmacy sell-out sales in units
(10) Prindex “Drug prescriptions monitoring”
(11) SAP BW, ex-factory sell-out sales in units (2017: 39 million units sold overseas, 2018: 45 million units)
(12) Internal personnel statistics, headcount as of 31.12. (2017: headcount 1,635, 2018: headcount 1,736, both worldwide)
(13) Bronchipret® and Klimadynon® tablets