GP Bullhound advises Dudnyk on its sale to Fishawack

Gp Bullhound

GP Bullhound acted as exclusive financial advisor to Dudnyk, a Philadelphia-based healthcare marketing communications agency, on its sale to the Fishawack Group of Companies, one of the world’s leading independent healthcare communication specialists, based in Manchester, UK.

Independently owned for the past 25 years, Dudnyk is an award-winning, full-service agency that specializes in creating insight-driven, authentic brand experiences that unite specialty physicians and their patients.

Dudnyk President, Christopher Tobias, commented: “By joining forces with Fishawack, Dudnyk will be able to offer clients an even stronger service offering, including expertise in additional verticals like scientific communications and medical education. We are also excited to further expand our global capabilities, both commercially and medically, for our clients who operate on a scale outside of the US.”

Oliver Schweitzer, Executive Director at GP Bullhound, commented: “Dudnyk combines strategic, scientific and highly creative capabilities to bring to market life-changing brands and serve clients in the biotech, pharmaceutical, and medical device industries. We are delighted to have advised Dudnyk and to have helped them find the ideal partner for the next phase of growth.”

The transaction is further testament to GP Bullhound’s expertise in advising category leaders in the Digital and Marketing Services sectors, with more than 20 transactions completed in the last 24 months including the sales of Oliver to You & Mr Jones, Filter to Merkle, Kepler Group to KYU, and Solita to Apax Digital, among many others.

Inquiries
For inquiries please contact: Oliver Schweitzer, Executive Director, at oliver.schweitzer@gpbullhound.com

About GP Bullhound
GP Bullhound is a leading technology advisory and investment firm, providing transaction advice and capital to the world’s best entrepreneurs and founders. Founded in 1999, the firm today has offices in London, San Francisco, Stockholm, Berlin, Manchester, Paris, Hong Kong, Madrid and New York. For more information, please visit www.gpbullhound.com.

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Gimv sells Oldelft Ultrasound, producer of innovative ultrasonic probes for medical diagnostics

GIMV

In 2012, Gimv acquired a majority stake in medical diagnostics company Oldelft Ultrasound (Delft – NL, www.oldelft.nl), which develops and produces innovative ultrasonic probes for medical diagnosis, with the ambition of achieving further international growth through continuous development and expanding the product portfolio. Oldelft is the only independent player worldwide in the field of specialized TEE (transesophageal echocardiography) probes, serving, among other things, for cardiac imaging via the oesophagus.

Over the past seven years, continuous investment in R&D has further expanded Oldelft’s position as a technology leader in the growing echocardiography market. Leveraging its unique positioning, Oldelft has achieved impressive sales growth and built up an impressive global customer base of tier-1 OEMs in the market for ultrasound medical equipment. Recently a new type of probe, based on matrix/3D technology, has been developed and tested in the market.

Gimv announces today that it has sold on its majority shareholding in Oldelft in a management buy-out supported by Smile Invest.

Rob Smallenburg, CEO Oldelft: We are particularly happy at the support we have received from Gimv over the past 7 years. The good cooperation and Gimv’s knowledge of the field have enabled us to concentrate on Oldelft’s growth. Our continuous focus on innovation has enabled us to distinguish ourselves sustainably from other players. ”

Elderd Land, Partner, Gimv Health & Care platform: ” We look back with pleasure on the successful collaboration between Gimv and Oldelft. The growth figures and the recent development of the new matrix technology underline this success. Gimv is proud to have been to support Oldelf’s further expansion in recent years. Management has done an excellent job in this area. “

The yield on Oldelft over the entire investment period exceeds Gimv’s long-term average. No further financial details, however, are provided on the transaction itself. This transaction has no material impact on the NAV of Gimv.

 

 

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Nyxoah receives European CE Mark approval for the Genio™ system to treat sleep apnea

GIlde Healthcare

Utrecht, The Netherlands and Mont-Saint-Guibert, Belgium – Nyxoah S.A., a healthtech company focusing on the development of innovative solutions and services for sleep related disorders, today announced that the company has received CE Mark approval for the Genio™ system in Europe. The Genio™ system is the world’s first and only battery-free, leadless and minimally invasive neurostimulator, capable of delivering bilateral hypoglossal nerve stimulation for moderate to severe obstructive sleep apnea (OSA) patients who have failed conventional therapy.

The CE Mark approval was based on the BLAST OSA (BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnea) clinical study, a prospective study that evaluated the safety and performance of the Genio™ system in 7 centers in France and Australia.

“Patients from the BLAST OSA study show a major improvement in their sleep apnea symptoms and their Quality of Life” said Enrique Vega, Chief Executive Officer of Nyxoah.

Robert Taub, Chairman of Nyxoah said: “The sleep community is looking for alternative solutions for OSA patients who refuse currently available therapies or are not compliant. Having now received CE mark, Nyxoah’s Genio™ system is well on its way to fulfil this need”.

About Nyxoah

Nyxoah S.A., headquarted in Mont-Saint-Guibert – Belgium, is a healthtech company focused on the development of innovative, neurostimulation-based solutions and services for sleep related disorders. Nyxoah S.A. was co-founded in 2009 by Robert Taub. For more information, please visit www.nyxoah.com.

About Gilde Healthcare

Gilde Healthcare is a specialized European healthcare investor managing €1 billion across two business lines: a venture & growth capital fund and a private equity fund. Gilde Healthcare’s venture & growth capital fund invests in healthtech and therapeutics. The portfolio companies are based in Europe and North America. Gilde Healthcare’s private equity fund invests in profitable European healthcare services companies with a focus on the Benelux and DACH-region. The portfolio consists of healthcare providers, suppliers of medical products and other service providers in the healthcare market. For more information, visit the company’s website at www.gildehealthcare.com

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EURAZEO CAPITAL enters into exclusive discussions with MONTAGU to acquire DORC

Eurazeo

Paris, March 13, 2019 – Eurazeo Capital entered into exclusive discussions with funds managed by
Montagu Private Equity to acquire DORC (Dutch Ophthalmic Research Center). Eurazeo Capital will invest
close to 300M€ in this transaction. DORC will be the fifth investment of Eurazeo Capital IV. This investment
perfectly fits the strategy presented during the 2018 Annual Results presentation.
Established in 1983 and headquartered in the Netherlands, the company operates in the medical
technology sector and is one of the global leading specialists of vitreoretinal surgery. DORC designs,
manufactures and distributes ophthalmic surgery equipment, consumables and instruments.
The company serves over 5,700 surgeons and is recognized for its strong innovation capability. DORC is
a global company with a presence across 80 countries and enjoys strong market shares in Europe. DORC
has more than 500 employees worldwide.

Additional financial information will be disclosed at the closing of the transaction.
Marc Frappier, Managing Partner, Head of Eurazeo Capital commented: “The acquisition of DORC fits
perfectly with our investment strategy to support growing businesses with a strong international
development potential as they scale up. Widely recognized as innovative and best in class by surgeons
across the world, the Company delivers remarkable financial performance. We expect to leverage our
international network to accelerate DORC’s growth.”

DORC will engage to immediately inform and consult the employee representative bodies of the company.
The final closing of the transaction will occur once the process with employee representative bodies is
finalized and clearance from relevant antitrust authorities is obtained.
About Eurazeo
o Eurazeo is a leading global investment company, with a diversified portfolio of €17 billion in assets under
management, including nearly €11 billion from third parties, invested in over 300 companies. With its considerable
private equity, venture capital, real estate, private debt and fund of funds expertise, Eurazeo accompanies companies of all sizes, supporting their development through the commitment of its 235 professionals and by offering deep sector expertise, a gateway to global markets, and a responsible and stable foothold for transformational growth. Its solid institutional and family shareholder base, robust financial structure free of structural debt, and flexible investment horizon enable Eurazeo to support its companies over the long term.

Eurazeo has offices in Paris, New York, Sao Paulo, Buenos Aires, Shanghai, London, Luxembourg, Frankfurt and
Madrid.

o Eurazeo is listed on Euronext Paris.
o ISIN: FR0000121121 – Bloomberg: RF FP – Reuters: EURA.PA

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CXA Group Raises US$25 Million to Accelerate Expansion Across Asia-Pacific

Heritas

New investors HSBC, Singtel Innov8, Telkom Indonesia MDI Ventures, Sumitomo Corporation Equity Asia, Muang Thai Fuchsia Ventures, Humanica, Heritas Venture Fund and others join CXA’s latest financing round

This strategic capital will accelerate CXA’s growth momentum in the Asia-Pacific region and reinforce the company’s mission of improving the health and wellness of individuals through its employer-driven population health platform

CXA Group, Asia’s one-stop, predictive and data intelligence platform for better health, wealth and wellness choices, announced today that it has raised US$25 million in its latest round of funding. CXA’s new group of strategic investors include HSBC, Singtel Innov8, Telkom Indonesia MDI Ventures, Sumitomo Corporation Equity Asia, Muang Thai Fuchsia Ventures, Humanica and Heritas Venture Fund, underscoring the company’s aim to be the leading health ecosystem platform addressing escalating healthcare costs across the region.

The investment by these leading global financial services institutions, telecommunications providers and payroll companies reflect their belief in CXA’s long-term growth opportunity, and the company’s unique ability to shift healthcare spend from treatment to prevention, without employers spending more.

Rosaline Chow Koo, Founder and Chief Executive Officer, CXA Group said: “We are honoured to welcome these top-tier corporations into our roster of strategic investors and partners. CXA is today the leading health ecosystem platform that enables individuals across Asia to make better choices for healthier living, starting from the workplace, thereby empowering a shift in spend from treatment to prevention. We have seen overwhelming interest from global strategic investors who are excited to work with us to advance our business and vision.”

“These latest investors will become strategic partners, and we will look to closely collaborate in designing customised platform-led solutions for their B2B enterprise customers, and as importantly, the employees of these enterprises,” said Koo.

With chronic diseases hitting people in Asia earlier than in the West and healthcare costs escalating1, the company found that the antiquated pen-and-paper, one-size-fits-all approach to managing these costs was systemically wrong. This situation, if left unaddressed, would only get worse and become economically unsustainable over time.

The company has pioneered a one-stop, self-service platform that allows employers to give their employees access to an ever-widening range of health, wealth and wellness offerings, personalised based on the individual’s health and life-stage data. Employees can purchase offerings by drawing down on existing insurance policies provided by their employers and using funds that are then released into the platform’s eWallet to make transactions cashless, fast and easy.

Through the aggregation, anonymisation and analysis of digitised health and life-stage data, CXA helps employers get to the root cause of their workforces’ health issues and design specific interventions – such as corporate wellness and disease management initiatives – that will have the greatest impact on cost and health improvement, for reductions in tomorrow’s chronic disease and healthcare spend, today.

Headquartered in Singapore, CXA achieved revenue growth of 65 percent in 2018 and is expected to double that in 2019. This latest funding round follows US$33 million in total funding from Series A and B in 2015 and 2017 respectively. Other investors in CXA include B Capital Group, Openspace Ventures, Government-linked strategic investor EDBI, BioVeda Capital, FengHe Asia, Philips and RGAx.

Supporting Quotes from New Investors:

Edgar Hardless, Chief Executive Officer of Singtel Innov8 said, “CXA’s innovative use of analytics helps its enterprise clients effectively manage their healthcare costs and promote their employees’ wellbeing. We are excited to be an investor in CXA and help with their expansion across Asia.”

“CXA is rapidly emerging as a leader in the Health and Insurtech space. It has an innovative platform-led approach to helping companies optimise their health spend through personalised engagement with employees about their physical and financial wellness. We are excited about this investment partnership and the disruptive opportunities it presents,” said Bryce Johns, Group Head of Insurance, HSBC.

“Heritas invests in high-growth companies that are tackling major healthcare challenges faced by Asian populations,” said Chik Wai Chiew, Executive Director and CEO, Heritas Capital Management. “We are pleased to support CXA in this financing round to scale its employer-driven population health platform, as the company continues to pioneer solutions that connect the whole healthcare continuum and shift employers’ healthcare spend from treatment to prevention.”

Supporting Quotes from Previous Investors:

“Strategic investment in CXA from HSBC, Singtel Innov8 and others reinforces our belief in technology enablement and value creation from high-growth companies partnering with larger organisations and transforming in collaborative fashion. With the collective support of banks, insurers, telcos and payroll companies as co-investors, CXA can now accelerate its expansion into new markets and bancassurance channels, while creating new revenue opportunities for these partners’ businesses,” said Eduardo Saverin, Co-Founder and Partner, B Capital Group, the lead investor in CXA’s previous Series B funding round.

About CXA Group:

CXA Group is Asia’s one-stop, predictive and data intelligence platform for better health, wealth and wellness choices. Through the CXA platform, employers can empower employees with access to personalised health and lifestyle offerings, with clear and quantifiable ROI for the business. Founded in 2013 with the mission of transforming the delivery of employee benefits from pen-and-paper and one-size-fits-all to a digitised and personalised platform, the company aims to shift healthcare spend from treatment to prevention, to improve workplace population health.

Driven by a team of industry veterans with extensive leadership experience across Asia’s human resource, insurance, finance, healthcare and technology industries, CXA serves more than 600 enterprises, including Fortune 500 companies, and more than 400,000 employees in 20 countries. CXA has received recognition as InsurTech of the Year from the Asia Insurance Industry Awards and was among the top three most impactful innovations at the Singapore Digital Techblazer Awards.

CSAM Announces Deal to Acquire Arcid AS

Priveq

The transaction further strengthens CSAM’s leadership in the Nordic niche eHealth market
OSLO, Norway (March 12th, 2018) – CSAM announced today that it has signed an agreement
to acquire Arcid – a Norwegian eHealth company that focuses on information flow in the
teleradiology domain.

Arcid provides eHealth solutions that improve workflows and simplify the interaction between
healthcare professionals. Among the company’s best-known products are TRIS, a Radiology
Information System; Arcidis, a teleradiology information solution; and HelseMail, a Software as
Service (SaaS) communication platform that enables the encrypted transfer of large, high
volume, and sensitive patient information.

– The combination of CSAM and Arcid will create an innovative and comprehensive offering in
the medical imaging and connected health markets, enabling us to better serve clinicians and
patients, said Sverre Flatby, CSAM CEO. – Arcid has an impressive reputation for delivering
efficiency, quality, and exceptional patient care with their niche software solutions, and we are
pleased they have entrusted CSAM to carry on that tradition of excellence.

– I am confident that CSAM is the right home for Arcid’s team in this exciting growth period to
come, said Kåre-Bjørn Kongsnes, business developer and majority shareholder of Arcid. –
Integrating our highly competent team of people with CSAM, the leading Nordic niche player
within eHealth, strengthens this viable and powerful position.
The acquisition of Arcid is consistent with CSAM’s strategy to pursue growth through a
combination of strategic M&As and organic sales. The transaction is estimated to close before
the end of the month.

– Arcid’s products are an important complement to CSAM’s software solutions in the medical
imaging and connected healthcare domains, strengthening our leadership in these key market
segments, said Flatby. – The mixture of our customers, code and competencies will allow us to
provide even greater value to customers across both public and private healthcare
organisations.

CSAM has been a leading provider of medical imaging and connected healthcare solutions in
the Nordics for more than a decade. The company works closely with healthcare professionals
and organisations to develop software solutions that deliver the highest value for their
operations.

About CSAM
CSAM has established itself as a leading Nordic niche player in the specialised eHealth market
with a unique blend of best-in-class innovative technology, and outstanding human skills. The
company’s diverse portfolio of software solutions enables healthcare providers to access
relevant clinical information at the point of care. CSAM’s commercial headquarters are located
in Oslo, Norway. In addition to the new offices in Tromsø, the company also has local offices in
Stockholm, Karlstad, Gothenburg, Helsinki, Oulu, Tampere, and Warwickshire, as well as a
wholly owned software engineering subsidiary in the Philippines.
A privately-owned company backed by strong financial partners, CSAM aspires to achieve
continued growth both organically and through selected mergers and acquisitions. For more
information, visit www.csamhealth.com.

For more information, please contact:
Sverre Flatby, CEO Jennifer Goode, Communications Director
sverre.flatby@csamhealth.com jennifer.goode@csamhealth.com
+47 9159 9159 +1-705-760-0782
Kåre-Bjørn Kongsnes, Business Developer
kb@kongsnes.no
+47 900 11 040

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Gilde Healthcare acquires healthcare food supplier Eetgemak from Value8

GIlde Healthcare

Gilde Healthcare’s investment allows Eetgemak to realize new growth plans, including expansion into Belgium

Utrecht and Frankfurt – Gilde Healthcare, the European specialist investor in healthcare, acquires a majority stake in Eetgemak from stock listed investment firm Value8. The acquisition is the first investment in Gilde Healthcare’s new €200 million private equity fund focused on the healthcare industry. Katwijk based Eetgemak is the market leader in chilled meals for Dutch healthcare institutions. With Gilde as a new investor, Eetgemak will further expand its market position by growing in both existing as well as new markets, like Belgium.

Doctors and dietitians increasingly recognize the importance of tasty, healthy food that meets the patient’s wishes in the healing process. At the same time, there is a constant pressure on healthcare institutions to work more efficiently and to provide better care with less staff. With an assortment of thousands of different chilled meals, Eetgemak offers hospitals, care institutions and people at home healthy meals at low prices. Moreover, through its scale and expertise, Eetgemak is able to cater to the many types of dietary needs of patients and residents in care institutions.

The investment in Eetgemak fits well in Gilde Healthcare’s new private equity fund: “We look for companies that contribute to the improvement of care. Moreover, we actively contribute to the development of our portfolio companies through our specific knowledge and experience in the healthcare industry. We are very excited about Eetgemak’s growth opportunities and look forward to a productive collaboration,” says Hugo de Bruin, partner at Gilde Healthcare.

“Gilde’s investment enables us to execute our growth strategy, not only in the Netherlands, but also across the border in Belgium. In addition to accelerating organic growth, we are also interested in new partnerships and potential acquisitions,” says Leo van der Krogt, CEO at Eetgemak.

About Eetgemak

Eetgemak prepares chilled meals for hospitals, home care organizations, care centers, nursing homes, expertise centers, service apartments, living communities, restaurants, caterers, schools and daycare centers. Professional chefs prepare a wide range of seasonal dishes with great pleasure every day. Our motto is ‘everyone joins for dinner’. Whether it’s preference, meal type, consistency or diet; taste and quality are always paramount. Everyone deserves a healthy, fresh and tasty meal. This is why every day we cook fresh and healthy meals with the best ingredients. https://www.eetgemak.nl

About Gilde Healthcare

Gilde Healthcare is a specialized European healthcare investor managing €1 billion across two fund strategies: private equity and venture & growth capital. Gilde Healthcare’s private equity fund invests in profitable European lower mid-market healthcare companies including healthcare providers, suppliers of medical products and service providers, with a primary focus on the Benelux and DACH regions. Gilde Healthcare’s venture & growth fund is focused on fast growing health tech and therapeutics companies based in Europe and North America. https://gildehealthcare.com

 

Media Contacts

Gilde Healthcare

Hugo de Bruin
Partner
Newtonlaan 91
3584BP Utrecht
The Netherlands
debruin@gildehealthcare.com
+31 (0)30 219 2565

Eetgemak

Leo van der Krogt
CEO
Taanderstraat 9a
2222 BG Katwijk
The Netherlands
leo@eetgemak.nl
+31 (0)71 408 4140

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Gilde Healthcare leads EUR 20M Series A financing round of Calypso Biotech

GIlde Healthcare

Utrecht, The Netherlands and Boston, US – Calypso Biotech (Amsterdam, The Netherlands), an emerging leader in the development of therapeutic antibodies for autoimmune diseases, announces today the closing of a €20M Series A financing led by Gilde Healthcare and Inkef Capital. They are joined by Johnson & Johnson Innovation – JJDC, Inc. (JJDC), and the company’s founding investor M Ventures. Further, Calypso Biotech has become Resident Company at Johnson & Johnson Innovation JLABS at Beerse in Belgium (JLABS@BE). Arthur Franken from Gilde Healthcare will join the Board of Directors.

The proceeds from this financing round will support the development of Calypso Biotech’s best-in class anti-Interleukin-15 (IL-15) antibody CALY-002 up to First-in-Patient studies in several autoimmune indications. IL-15 is an immune checkpoint cytokine that controls inflammation as well as multiple tissue-resident immune cells and recently attracted much attention in the immune-oncology space. Especially, IL-15 is being recognized as a key factor in the survival of tissue resident memory T cells, a population of immune cells involved in disease maintenance and recurrence. Calypso Biotech scientists believe that targeting tissue resident memory T cells offers significant advantages over traditional cytokine interventional approaches and could provide for unprecedented disease-modifying effects.

Calypso Biotech has chosen to develop CALY-002 in Eosinophilic Esophagitis (EoE) as well as in other undisclosed auto-immune indications. EoE is a severe and debilitating immune-related chronic disease of the esophagus that is the second leading cause of dysphagia (difficulty in swallowing) in adults. EoE has emerged as a frequent and significant cause of upper gastrointestinal morbidity particularly associated with important quality of life impairment and significant financial healthcare burden. CALY-002 has secured Orphan Drug Designation status from the European Medicines and Food & Drug Administration agencies for EoE.

Calypso Biotech is also announcing major strengthening of its team. Bernard Coulie, current president and CEO of Pliant Therapeutics, will be appointed as independent Chairman of the Board. Together with Alexandre LeBeaut, Executive Vice-President and CSO of Ipsen and current independent Director of Calypso Biotech, they will contribute to develop its strategic vision and corporate success. Prof. Bart Lambrecht, from the VIB-UGent Center for Inflammation Research (Belgium), a leading translational immunology expert, will join Calypso Biotech Scientific Advisory Board. Dr. Josephin-Beate Holz (ex Ablynx NV), Dr Greg Elson (ex Glenmark, Novimmune), Dr Susana Salgado (ex Novimmune), and Duc Tran (ex Prexton Therepeutics, Preglem, Pfizer) will join as medical, manufacturing, non-clinical development and strategic planning advisors, respectively.

About Calypso Biotech BV
Calypso Biotech BV is a private biotechnology company focused on the research and
development of novel biologics to address unmet medical need in immunological diseases, especially gastrointestinal indications. Calypso Biotech was established in 2013 as a spin-off by the healthcare business of Merck founded by Alain Vicari, Yolande Chvatchko and M Ventures, and is headquartered in Amsterdam, The Netherlands. Calypso is led by a team with strong experience and track record in translational immunology and the development of biologics, supported by an advisory board of clinical experts. For more information www.calypsobiotech.com

About Gilde Healthcare
Gilde Healthcare is a specialized European healthcare investor managing €1 billion ($1.2 billion) across two fund strategies: venture & growth capital and private equity. Gilde Healthcare’s venture & growth capital fund invests in health tech and therapeutics. The venture & growth companies are based in Europe and North America. Gilde Healthcare’s private equity fund invests in profitable European lower mid-market healthcare companies with a focus on the Benelux and DACH region. The private equity fund targets healthcare providers, suppliers of medical products and service providers in the healthcare market.
For more information www.gildehealthcare.com

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Bluebee receives Health Data Hosting (HDS) accreditation

Rijswijk, The Netherlands: 6 March 2019 – Bluebee, a global bioinformatics solutions provider, has been awarded the HDS:2018 certification for its Information Security Management System (ISMS). The Hébergeurs de Données de Santé or Health Data Hosting (HDS) accreditation is required for entities hosting personal health data governed by French laws. The British Standards Institution (BSI) conducted the audit and confirmed Bluebee’s compliance with all requirements and controls defined by the French Agency, Agence des Systèmes d’Information Partagés de Santé (ASIP).

Bluebee’s ISMS governs HDS outsourcer host activities, including development, management, support and maintenance of cloud infrastructure and cloud-based information systems that process large volumes of omics and health data. The achievement of this accreditation reaffirms Bluebee’s continued commitment to providing the most secure and reliable data management solutions to clinical laboratories, diagnostic assay manufacturers and population genomics initiatives.

Axonics® Announces Fourth Quarter and Full Year 2018 Financial Results and Operational Update

GIlde Healthcare

IRVINE, CA – Axonics Modulation Technologies, Inc. (NASDAQ: AXNX) a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, reported today financial results for the fourth quarter and year ended December 31, 2018, and provided an update on operational initiatives.

Recent Business Highlights

  • In Q4, commercial sales of the miniaturized rechargeable Axonics r-SNM® System totaled $0.5 million.
  • On February 11, filed full-body magnetic resonance imaging (“MRI”) data with the U.S. Food and Drug Administration (“FDA”) seeking conditional labeling for the miniaturized rechargeable Axonics r-SNM System.
  • On February 19, disclosed top-line six-month clinical results on the full cohort of patients for the ARTISAN-SNM pivotal clinical study of the Axonics r-SNM System which indicated 90% of all implanted subjects met the efficacy endpoint and that the study met all primary and secondary endpoints.
  • On February 21, filed a detailed six-month clinical study report with the FDA on the results of the ARTISAN-SNM pivotal clinical study.
  • On February 22, announced CE Mark approval for full-body MRI conditional labeling in Europe for the Axonics r-SNM System, making the Axonics system the first SNM device that allows a safe full-body MRI scan while implanted.
  • On March 4, appointed Michael H. Carrel to the Board of Directors.

Raymond W. Cohen, CEO of Axonics, commented, “We view the generation of $0.5 million of revenue in the fourth quarter, serving a handful of customers with a small team of sales professionals, to be a harbinger of things to come. We are seeking measurable market share gains in 2019 from our two primary markets in Europe, the United Kingdom and the Netherlands. The accounts we have secured in these markets are exceeding our expectations in terms of the percentage of SNM implants using the Axonics system. Moreover, we now have the only SNM device with full-body MRI labeling, an advantage that should aid us in gaining further traction.”

Cohen continued, “Our primary focus continues to be gaining FDA approval in the shortest possible timeframe. To that end, and based on interaction with the FDA, we determined our best course of action was to further enrich our current literature-based PMA with the full cohort of ARTISAN-SNM study data as well as the full-body MRI data. As we advance our regulatory strategy, we continue to press forward on our initiative to be fully prepared to execute a broad, fully staffed U.S. launch upon FDA approval. We are building a world-class team and have been pleased that many experienced neuromodulation and urology professionals view Axonics as an attractive place to work that represents an exciting career opportunity. Overall, we are making excellent progress on our key operational objectives.”

Fourth Quarter 2018 Financial Results

Net revenue was $0.5 million in the fourth quarter ended December 31, 2018, derived from the sale of the Company’s r-SNM Systems to customers in Europe and Canada, as compared to no net revenue for the same period of last year.

Gross margin was 50.4% in the fourth quarter of 2018.

Operating expense was $9.7 million for the fourth quarter of 2018, as compared to $4.9 million in the prior-year quarter. This increase was primarily due to higher personnel costs across the organization as well as the costs of operating as a public company.

Net loss for the fourth quarter of 2018 was $9.7 million as compared to $4.9 million in the prior-year quarter. Net loss per share for the fourth quarter of 2018 was $0.50 per share.

As of December 31, 2018, cash, cash equivalents and short-term investments were $157.5 million.

Dan L. Dearen, Axonics President and CFO, said, “We have been actively hiring commercial, operations, regulatory, and quality personnel to ensure we execute on our strategy of fielding a full complement of sales and marketing professionals with sufficient inventory on hand to support a U.S. launch upon FDA approval. To date, we have hired 60 well-qualified sales professionals, 11 regional sales directors and 12 clinical specialists, putting us ahead of schedule and in a good position with the build out of our team and its ability to execute if the approval were to come before our initial projection. The accelerated costs associated with that shift puts us in the best position to achieve our commercial goals when approved.”

Full Year 2018 Financial Results

Net revenue was $0.7 million in fiscal year 2018, derived from the sale of the Company’s r-SNM Systems to customers in Europe and Canada, as compared to $0.1 million in fiscal year 2017.

Gross margin was 49.7% in fiscal year 2018, compared to 7.9% gross margin in fiscal year 2017. The increase in gross margin is primarily due to country and product mix.

Operating expense was $32.5 million in fiscal year 2018, as compared to $18.2 million in fiscal year 2017. This increase was primarily due to increases in personnel, regulatory submissions and clinical development, contract fabrication and manufacturing, and legal costs.

Net loss for the year was $32.5 million as compared to $18.1 million in the prior year. Net loss per share for fiscal year 2018 was $4.64 per share.

Webcast and Conference Call

Today, on Tuesday, March 5, 2019, at 4:30 p.m. Eastern Time, the Company will host a conference call with the investment community to discuss the financial results and recent business developments.
Interested parties may access the live call via telephone by dialing (866) 687-5771 (U.S.) or (409) 217-8725 (International) and using conference ID 3386378.

A live webcast of the call may be accessed by visiting the Events & Presentations page of the investors section of the Company’s website at ir.axonicsmodulation.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Company’s website for 90 days.
About Axonics Modulation Technologies, Inc.

Axonics, based in Irvine, CA, is focused on the development and commercialization of novel implantable Sacral Neuromodulation devices for patients with urinary and bowel dysfunction. Overactive bladder affects an estimated 87 million adults in the U.S. and Europe. Another estimated 40 million adults are reported to suffer from fecal incontinence. SNM therapy is a well-established treatment that has been widely used and reimbursed in Europe and the U.S. for the past two decades. The Axonics r-SNM System is the first rechargeable Sacral Neuromodulation system approved for sale in Europe, Canada and Australia, and the first SNM system to gain CE mark for full-body MRI conditional labeling. Premarket Approval (PMA) for the r-SNM System is currently pending with the U.S. FDA. For more information, visit the Company’s website at www.axonicsmodulation.com.

Forward Looking Statements

Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as “planned,” “expects,” “believes,” “anticipates,” “designed,” and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Axonics filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Axonics undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.

 

Contacts:

Axonics’ Contact

Axonics Modulation Technologies, Inc.
Dan Dearen, +1-949-396-6320
President & Chief Financial Officer
ir@axonics.com

Investor & Media Contact

W2Opure
Matt Clawson, +1-949-370-8500
mclawson@w2ogroup.com

 

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