Mainstay Medical International plc Management Presentation - PowerPoint PPT Presentation

Mainstay Medical International plc Management Presentation December 2018 Confidential

Important Notice and Disclaimer Important Notice and Disclaimer References herein to this presentation (the “Presentation”) shall mean and include this document, any accompanying oral presentation and any question and answer session. This Presentation is for information purposes only. The information and opinions contained in this Presentation speak only as of the date of this document. Mainstay Medical International plc (the “Company”) is not under any, and undertakes no, obligation to update or keep current the information contained in this Presentation and any information or opinions expressed therein are subject to change without notice. The information and opinions do not purport to be exhaustive and have not been independently verified. No representation or warranty, express or implied, is made by the Company or any of its directors, officers, employees, affiliates, agents or advisers as to the accuracy, completeness, or fairness of the information or opinions contained in this Presentation and no responsibility or liability whatsoever (in negligence or otherwise) is accepted by any of them for any loss arising, directly or indirectly, for use of this presentation or its contents or otherwise arising in connection therewith. All statements in this Presentation other than statements of historical fact are or may be deemed to be forward looking statements. They appear throughout this Presentation and include, but are not limited to, statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, the data from the ReActiv8-B clinical study, the Company’s plans in relation to that data, and the Company’s results of operations, financial position, prospects, financing strategies, expectations for product design and development, regulatory applications and approvals, reimbursement arrangements, costs of sales and market penetration and other commercial performance. By their nature, forward looking statements involve risk and uncertainty because they relate to future events and circumstances. Forward looking statements are not guarantees of future performance and actual results may differ materially from those described in, or suggested by, the forward looking statements contained in this Presentation. A number of factors could cause actual results and developments of the Company to differ materially from those expressed or implied by the forward looking statements including, without limitation, the successful launch and commercialization of ReActiv8, the ability to raise additional capital to fund the Company’s business and the cost of such capital, the outcome of the ReActiv8-B clinical study, the outcome of the Company’s interactions with the FDA on a PMA application for ReActiv8, general economic and business conditions, the global medical device market conditions, industry trends, competition, changes in law or regulation, changes in taxation regimes, the time required to complete clinical trials and to obtain regulatory approvals, currency fluctuations, changes in its business strategy, and political and economic uncertainty . The principal risks and uncertainties faced by the Company remain substantially unchanged from the disclosures included in the Company’s Half Year Report for the period ended 30 June 2018 published by the Company on 21 September 2018, which risks and uncertainties should be read in conjunction with the Company’s public disclosures, which are available on the Company’s website (www.mainstay-medical.com). The forward-looking statements herein speak only at the date of this Presentation, and the Company disclaims any obligation to update or revise any such forward-looking statements except as may be required by applicable law. This Presentation is not an offer to sell, or the solicitation of an offer to purchase, the Company’s securities in any jurisdiction. 2

Experienced Senior Management Team NuVasive President/COO, Head of International Jason Hannon, CEO business 20 years of experience (Mainstay, CVRX, Prashant Rawat, Chief Operating Officer Guidant) 20 years experience (Biogen, Elan, Ignyta, Matt Onaitis, Chief Financial Officer Cidara) Tom Maher, SVP Corporate Affairs and Chief Legal 20 years of experience (Amarin, Elan) Officer Confidential 3

Table of Contents I. Executive Summary II. Clinical Data Update III. Commercial Overview IV. Financial Overview Confidential 4

I. Executive Summary

Investment Highlights Estimated 2 million ReActiv8 candidates in the US and European Union today US approval anticipated in 2020 Direct sales in Germany Strong R&D capabilities will drive platform evolution Experienced leadership team with global commercialization background Confidential 6

ReActiv8 — Using Neurostimulation to Reactivate Normal Muscle Control for Patients with CLBP  Novel implantable neurostimulation device providing electrical stimulation to the multifidus muscle ✓ Initial indication: Chronic Low  Targets an underlying cause of CLBP, rather than Back Pain (CLBP) masking pain ✓ Focused on patients with non- specific CLBP (those not  Potential therapy option for patients taking opioids to indicated for surgery) manage pain  Minimally invasive implantation procedure  Compelling clinical data demonstrates efficacy  CE Marked and approved in Europe  Application for Australian approval anticipated in 2019  U.S. PMA submission expected in 2019 after pre- PMA meeting Confidential 7

Chronic Low Back Pain Disease Overview  Characterized by low back pain that has persisted for at least three months and has resulted in pain on at least half the days in the past six months  Debilitating condition negatively impacting patient’s ability to live a normal life  Often the source of the pain is not known  ~1% – 6% of population suffers from CLBP Disease Burden  Associated costs of ~$100 to $200 billion annually in the US  Patients often resort to high socio-economic cost pain management options including opioids Disease Management  Patients typically cycle through options, often unsuccessfully ~150 million days of work per year are lost due to low back pain in the US and EU Confidential 8

The Multifidus Muscle and Its Role  Deep muscle located along the back of the spine  Primary stabilizer of the lumbar spine  Constrains movements of the facet joints to reduce stress and avoid injury  Controlled involuntarily by the brain  Contracts automatically when the brain senses that stability of the spine is required Confidential 9

ReActiv8 Mechanism of Action  Initial injury causes stabilizers of the lumbar spine to become inhibited  Inhibition of neural signals causes loss of control of multifidus muscle  This results in patients experiencing continuing, debilitating pain and disability  Ability to restore muscle control with electrical stimulation  Treats an underlying cause of CLBP vs. masking the pain Confidential 10

The Genesis of ReActiv8 Restorative Therapy It was hypothesized that targeted electrical stimulation to cause episodic contraction of the multifidus muscle alone could lead to restoration of neuromuscular control of the multifidus muscle, leading to improved functional stability of the lumbar spine and resolution of CLBP Evidence of Electrical Stimulation for Arthrogenic Inhibition  Knee surgery causes quadricep atrophy due to arthrogenic inhibition  Transcutaneous NMES can restore neural drive to quadriceps to reverse atrophy and increase strength, endurance, and tone  Nerve to quadriceps is close to skin allowing transcutaneous stimulation  Transcutaneous stimulation cannot reach motor point of the multifidus Confidential 11

Our Solution: ReActiv8 Therapy Reactivates the Multifidus Muscle Self-anchoring leads placed adjacent to Medial Branch  Percutaneous placement  Known implantation techniques and anatomical target (rhizotomy)  Minimally invasive procedure; rapid patient recovery Implantable Pulse Generator delivers stimulation to contract the Multifidus Muscle  30 Minute patient controlled session twice daily via remote control  >5 year longevity  Patient compliance benefit relative to physical therapy Confidential 12

Limitations of Current Treatment Options Conservative Care  Cognitive Behavioral Therapy: only addresses psychosomatic aspects  PT: therapists try to teach the patient to voluntarily contract the multifidus – most unable to do so Specialist Interventions  Steroid injections: pain relief is temporary; can have harmful side effects  Nerve blocks: pain relief is temporary; permanent nerve damage can occur  Energy application: pain relief is temporary; not an effective treatment for CLBP  Rhizotomy or nerve ablation: low back pain can return, requiring another procedure ReActiv8 Indication Patients typically cycle through the various Long-Term Pain Management treatment options,  Opioids and anti-depressants: severe side effects, potential for addiction and mortality often unsuccessfully Spine Surgery and Spinal Cord Stimulation  Surgery: fusion historically tried but no longer supported by guidelines and payors  SCS: typically used for neuropathic pain CLBP patients are usually poorly served with available treatment options Confidential 13