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Interim Report January – September 2020 Q3

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Interim Report January – September 2020 Q3 Interim Report January – September 2020 Q3 Financial summary Third quarter First nine months • Net sales amounted to EUR 27k (0) • Net sales amounted to EUR 126k (21k) • Operating loss (EBIT) increased to EUR 4,790k • Operating loss (EBIT) increased to EUR 7,291k (748k) driven by listing costs (3,490k) driven by listing costs • Loss after tax amounted to EUR 4,730k (815k) • Loss after tax amounted to EUR 7,127k (3,602k) • Basic and diluted loss per Class A share amounted to EUR 0.10 (0.02) • Basic and diluted loss per Class A share amounted to EUR 0.16 (0.08) • Liquid funds as at end of the period amounted to EUR 90.5m • Cash flow from operating activities amounted to EUR -1,824k (-3,014k) • No interest-bearing debt at end of the period Figures within parentheses refer to the preceding year. Significant events • Enlisted Inselspital Bern, the largest In the third quarter of 2020 university hospital in Switzerland, to be the lead hospital in our upcoming RefluxStop™ • Completed listing on Nasdaq First North Premier Growth Market raising SEK 1.1 Registry clinical trial to be focused primarily billion, with trading of Implantica's Swedish in Germany and Switzerland. Depository Receipts commencing on September 21, 2020. The offering was After the end of the period substantially oversubscribed. • Exercised overallotment option raising an additional SEK 165 million. • Increased our shareholder base with highly reputable shareholders such as Swedbank • Implantica’s RefluxStop™ trial showed Robur Ny Teknik, Handelsbanken Fonder, exceptional three-year follow-up results. TIN Fonder, Skandia and Nordea Investment None of the 47 patients in the study were in Management. need of regular daily use of PPIs (proton- pump inhibitors), which were taken by all • Furthered board optimization with highly before surgery. experienced Tomas Puusepp, former CEO of Elekta AB, formally joining the Implantica • Implantica completed a pre-submission to board. the U.S. Food and Drug Administration (FDA) for RefluxStop™. • Published successful results of the RefluxStop™ CE mark trial in medical • In executing its commercialisation strategy, journal, BMC Surgery. Implantica recruited additional sales representatives in Germany. Interim Report | Q3 January – September 2020 1 CEO Comments Building the Future of Healthcare “Our platform technologies and products are designed to bring much-needed relief for millions of suffering in- dividuals, while substan- tially reducing the economic burden on society” It is with great pleasure that we provide our first the hands of surgeons around the world. The quarterly report since listing on Sweden’s listing process also sends a powerful signal to Nasdaq First North Premier Growth Market on the market, strengthening our brand among 21 September. patients, surgeons and other investors. In the third quarter of 2020, Implantica was suc- Despite the large effort and time it took to list cessfully listed on the public market, which has the shares, we continued to drive the business been the company’s goal for quite a while. I forward during the third quarter. We have a would like to give thanks to the team at Implan- clear plan for our lead product RefluxStop™ and tica who helped make this happen and to all of Implantica is in a strong financial position going our new investors who have put their trust in us. forward. A good deal of time has been spent on We are very happy for the enormous interest we prioritising and strategy planning. received during the process and the offering was substantially oversubscribed. A total of We are in the process of commercializing Re- SEK 1.27 billion kronor was raised from highly fluxStop™ in Europe, and we have started to in- reputable shareholders such as Swedbank Ro- crease the number of sales representatives in bur Ny Teknik, Handelsbanken Fonder AB, TIN Germany. We filed a pre-submission to the U.S. Fonder, Skandia and Nordea Investment Man- Food and Drug Administration in October and agement to name a few. expect to receive an initial meeting with the FDA early next year at which time we will have We are thrilled to have such an overwhelming a better understanding of the path forward for level of confidence in our team and products as regulatory approval in the US. we push forward to putting these products in Interim Report | Q3 January – September 2020 2 We are pleased to have recently announced the Besides the extensive time and effort spent in exceptional 3-year results of the RefluxStop™ the preparation of the listing on Nasdaq First study. After three years, none of the 47 patients North, additional accomplishments during the in the study took regular daily PPI (proton pump third quarter include: inhibitors) medication and no serious adverse events were reported since the 1-year data was • Tomas Puusepp the former CEO of Elekta published. These remarkable long-term results formally joined the Implantica board in will provide the foundation for the growth of August. He will guide us with his RefluxStop™ going forward. These results will invaluable experience in medical device also substantially increase the likelihood that sales and reimbursement. we will create a paradigm shift in acid reflux • Our successful results of the RefluxStop™ treatment once the arduous reimbursement CE mark trial were published during the process is accomplished. third quarter. Our strategy for commercializing RefluxStop™ • Ongoing set-up of Registry clinical trial and promoting the device to become a new mainly focused in Germany and global surgical standard for the treatment of Switzerland involves: acid reflux is based on the following on-going o Switzerland’s largest University steps: Hospital, Inselspital in Bern will be the • Arrange for regulatory approvals for lead hospital, with surgeon Dr. Borbély RefluxStop™ in our prioritised markets. in charge. • Publish the results of a cost benefit o In Switzerland, Hirslanden Bern Prof analysis, which will support upcoming Zehetner and Hirslanden Zurich Prof reimbursement processes. Schoeb will join. • Increase patient awareness and generate o In Germany, a multitude of German patient pull through the creation of a Hospitals are interested to join the digital marketing campaign targeted to Registry and start when Corona is over. patients and referring medical doctors. o On-line patient reporting system has • Secure large-scale medical evidence by been developed together with establishing a Registry study in Germany Southampton University. and Switzerland. o Comparative data is achieved by • Create comparative data by targeting to including other surgeries than set up a 3-arm randomized study. RefluxStop™ in the Registry as well. • Expand surgical training in the o Organising surgical training in the RefluxStop™ operating technique RefluxStop™ operating technique by through the use of enhanced video and online meetings with key opinion even real-time videos. leaders including video presentations and 3-year results – with ability to ask • Use a multi-pronged approach with local questions. specialists to achieve reimbursement in targeted markets throughout Europe. Interim Report | Q3 January – September 2020 3 I wanted to shortly comment on how Covid-19 technologies and products are designed to is impacting Implantica. The virus has reduced bring much-needed relief to suffering individu- elective surgeries and therefore we have fo- als, while substantially reducing the economic cused on building a strong relationship with and burden on society. expanding our network of surgeons who would like to start to operate with RefluxStop™ when We have an exciting future ahead of us. Thank the second wave of corona is over. you for your interest in Implantica. Implantica focuses on bringing advanced tech- nology into the body, and we target to play a Yours sincerely, key role in changing the future of healthcare. With eHealth healthcare will take a leap when Dr. Peter Forsell advanced technology enters the body, in the CEO Implantica and Founder, same way that advanced technology has Specialist in General Surgery and Inventor changed our daily lives. Our platform Interim Report | Q3 January – September 2020 4 Implantica in brief Implantica is a medtech group committed to by a portfolio of 25 patents. In addition, the providing effective care for serious health con- Company has developed an eHealth platform ditions and improving patient quality of life by for communicating with and reprogramming bringing advanced technology into the body. implants from distance, which is covered by pa- Simultaneously, Implantica aims to reduce tents on 14 individual inventions. overall costs and improve efficiency in the healthcare system. Implantica’s most progressed product, Refux- Stop™, represents a potential paradigm shift in The therapies Implantica develops are based on the treatment of GERD. Acid reflux has a signif- implants. Implants are medical devices that are icant impact on patient quality of life and can in- inserted into the patient’s body and are in- duce serious complications, including increased tended to remain in place permanently or semi- risk for oesophageal cancer. GERD patients rely permanently, and may be passive, or unpow- today, to a large extent, on PPIs – a drug ther- ered, or active, using electrical power provided apy which calms symptoms of GERD. Ulti- by a battery. Implantica has developed a broad, mately, with PPI treatment reflux is not pre- patent protected, product pipeline, two-thirds vented and the risk for oesophageal cancer re- of which
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