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Year-end Bulletin 2016

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“We continue to build a new global leader in the field of patient monitoring”

Significant events during the first quarter

  • March 2016. Senzime has been appointed one of ten leading medical technology companies by the CEBR - Council for European bioregions.

Significant events during the second quarter

  • April 2016. Senzime receives research grant from Vinnova through BIO-X to conduct a study designed for clinical evaluation of OnZurf Probe and CliniSenz Analyzer for postoperative monitoring of patients with esophageal cancer. The grant amounts to SEK 2 million, and the study will be conducted in Lund.
  • May 2016. Senzime acquired Acacia Designs BV (”Acacia”), an international development company within anesthesia monitoring. The acquisition was financed by 16,076,730 newly issued shares in Senzime through a non-cash issue. After the acquisition, Acacia’s shareholders owned 50 percent of the shares in Senzime. In connection with the acquisition, a rights offering to existing shareholders was made, amounting to 15.2 million SEK before transaction expenses.
  • June 2016. New shares issue with preferential rights for existing shareholders was performed and was subscribed to 92.6 percent of the original offer. The remaining 7.5 percent of the shares is allocated to the underwriters.
  • June 2016. Senzime has hired Jessica Roxhed as new CFO and Catrin Molund as new Director of Business development. Both will join Senzime starting on September 1.

Significant events during the third quarter

  • July 2016. New share issue with preferential rights for existing shareholders that was performed during May – June is now registered with the Company´s Registration Office.
  • August 2016. Örebro University has been awarded SEK 11 million and will together with Senzime, Sandvik, Techtum and Nanoxis explore why the immune system reacts differently in different people after an operation, during an infection or because of polluted air.

Significant events the fourth quarter

  • October 2016. New Swedish registry study – a national collaboration between Senzime, Swedish Medtech, Skåne University Hospital in Lund and University of Gothenburg and the national quality registry for esophageal and gastric cancer.  A clinical trial investigating the OnZurf Probe for continuous, organ specific monitoring of lactate trends in postoperative esophageal cancer patients is ongoing in Lund. The clinical trial is being expanded in order to examine how the new OnZurf Probe solution may mitigate the healthcare costs associated with this disease.
  • November 2016. Senzime is initiating a series of clinical studies to be performed at Mayo Clinic, USA. The studies are intended to evaluate Senzime’s patient neuromonitoring system called TetraGraph, used during anesthesia. The clinical validation studies at Mayo Clinic are intended to compare its usability to that of the now-discontinued former market leading monitoring system.
  • November 2016. Senzime launches a clinical study at NorthShore University HealthSystem, Chicago, USA, a Teaching Affiliate of the University of Chicago Pritzker School of Medicine. Professor Glenn Murphy will head this clinical investigation of the leading neuromuscular monitoring system, the TetraGraph. This study is designed to investigate the clinical utility of the TetraGraph System in a total of 150 patients.
  • November 2016. Senzime launches a clinical study at the University of Debrecen, Hungary. This study will evaluate Senzime’s patient neuromonitoring system TetraGraph. This study is designed to investigate the clinical utility of the system in a total of 40 patients, and will compare its ease of use, reliability and precision to the former leading product, the TOF-Watch, that has been discontinued from the market.
  • December 2016. Senzime has signed an exclusive licensing agreement with Japanese Fukuda Denshi Co Ltd (“Fukuda”). The agreement gives Fukuda the exclusive right to license and commercialize Senzime’s TetraGraph system in Japan with market launch expected by the end of 2017. Senzime’s management and board expects this 10-year agreement to generate more than SEK 100 million in license revenue related to future milestone payments and royalties.
  • December 2016. Senzime launches OnZurf Probe for use in preclinical research. Onzurf Probe has a unique mode of attachment to the target organ, allowing easy placement of the microdialysis catheter on the surface of the organ. This non-invasive technique obviates the need for penetrating surgical instruments that can cause tissue trauma and stress during placement of the probe. 

Significant events after the end of the period

  • January 2017. Senzime, in collaboration with the principal investigator Dr. J. Ross Renew, a recognized researcher in the area of neuromuscular pharmacology and physiology at Mayo Clinic’s Florida USA location in Jacksonville carried out a validation study in volunteers to evaluate TetraGraph.
  • January 2017. The previously announced date of the report, February 22, is brought forward to February 16 2017.
  • January 2017. Senzime announces the nomination committee for the AGM 2017. The Nomination Committee is appointed in accordance with the principles adopted at the AGM 2016.
  • January 2017. Senzime reports initial evaluation from the clinical trial at NorthShore in Chicago, USA. Senzime in collaboration with Professor Glenn Murphy is performing a study, investigating the TetraGraph monitor’s accuracy and consistency, while collecting clinician usability data.
  • February 2017. Senzime signs distribution agreements for the TetraGraph. Senzime has entered exclusive distribution agreements for the commercialization of TetraGraph with Wardray Premise Ltd., who will be the exclusive distributor in the UK and Ireland and LSR Healthcare who will be the exclusive distributor in Australia and New Zealand. Compensation to distributors will be paid on a “per-unit sold” basis, and is in line with current industry compensation, in which there are no guaranteed sales.
  •  February 2017. The Board of Senzime proposes that an extra general meeting resolves on a rights issue of approximately SEK 24.4 million before issue costs. The rights issue is fully underwritten by the company's principal owner. The proceeds will be used to enable the commercialization of Senzimes products and strengthen its financial position. Concurrently Senzime is planning a listing at Nasdaq First North.

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Financial information fourth quarter 2016

  • Net sales amounts to KSEK 185 (42)
  • Income after financial items amounts to KSEK -3,572 (-1,813).
  • Earnings per share before dilution amounts to SEK -0.10 kr (-0.11).
  • Cash and cash equivalents per December 31, 2016 equal SEK 10.0 million (14.5).
  • Number of shares per December 31, 2016 amounts to 36,172,643 (16,076,730).

Financial information January – December, 2016

  • Net sales amounts to KSEK 1,628 (153).
  • Income after financial items amounts to KSEK -9,412 (-7,582).
  • Earnings per share before dilution amounts to SEK -0.34 (-0.51).

Definitions. Earnings per share: Net income for the period divided by the average numbers of shares during the period. In parentheses describes comparative period last year. Unless otherwise stated, all information refers to the Group.

 

Statement of the CEO

The global launch has begun

Today, Senzime has taken another big step toward reaching the market. We have begun the commercialization of our product portfolio and we aim to build a world-leading company in the perioperative patient monitoring arena. We will help decrease complications associated with surgery, increase patient safety, and lower health care costs. As a major step in this effort, we are conducting a rights issue that will provide growth capital and accelerate the global commercialization of our product portfolio.

Senzime has developed products to meet medical demand for solutions that can reduce complications associated with surgery, increase patient safety, and lower health care costs. The next exciting chapter begins for Senzime. Our competitive set of patient monitoring products is ready for global market launch. The strategic acquisitions we made in 2015 and 2016 have strengthened our portfolio, and now we can offer a number of medical devices that make it possible to monitor patients' biochemical and physiological processes before, during and after surgery.

The acquisition of Acacia Designs in 2016 opened the door to new markets, international collaborations with leading hospitals, and to a portfolio of solutions that solve critical clinical problems. Acacia has developed the TetraGraph, a completely new system to monitor the progress of neuromuscular block during anesthesia that will reduce complications in surgical patients. The system was unveiled at a trade show in late 2016, and received a very positive market response.

The introduction was followed by signing of an exclusive licensing agreement with the Japanese firm Fukuda Denshi, one of the global leaders in patient monitoring. The agreement means that Fukuda will license and commercialize Senzime’s TetraGraph system in the Japanese market, with launch expected by the end of 2017. The agreement is in force for 10 years; Senzime’s management anticipates that the agreement will generate more than 100 million SEK in license revenues in Japan alone, which accounts for about 2 percent of the total world market. This agreement represents a commercial breakthrough for Senzime - and since then, we have continued our market penetration by signing another distribution agreement in early 2017.

To further strengthen our market offering, we also have initiated study partnerships with two of the world's top hospitals - the Mayo Clinic and the NorthShore University Hospital, USA. The studies are intended to evaluate the clinical use of the TetraGraph system, and the first positive results from these studies were obtained in January 2017. The results will be presented in more detail during the first half of 2017.

We have also started a Swedish registry study in collaboration with Skåne University Hospital in Lund, University of Gothenburg, Swedish Medtech, and the National Registry of esophageal and gastric cancer. In Lund, a clinical study is being conducted with OnZurf Probe, our product for continuous, organ-specific measurement of lactate after surgery in patients with cancer of the esophagus, a disorder that affects approximately 500,000 patients worldwide, every year. This study has now been expanded in cooperation with other stakeholders to also evaluate healthcare economic issues. Results from this study are expected to be available in the second quarter of 2017.

We remain confident that we have highly attractive products and that we are in the right market at the right time. In recent months, we have signed a breakthrough agreement for the Japanese market, strengthened our organization, we are in discussions with potential license partners in additional markets; we expect several CE mark approvals, followed by a broad market introduction in 2017. Growth capital will create conditions to accelerate the global commercialization of our product portfolio and generate value ​​in line with our vision - Monitoring for Life.

We look forward to a continued eventful development in 2017!

Uppsala in February 2017

Lena Söderström, CEO of Senzime AB (publ)

This information is insider information that Senzime AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication trough the agency of the contact person set out above, on February 16th 2017

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