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May 17, 2018 Medical Technology
Sean Lavin, MD
(212) 527-3570 Helius Medical Technologies, Inc
slavin@btig.com Clear Benefit, Safety, and Unmet Need Tip the Balance
Marie Thibault Against Imperfect Data; Initiating w/a Buy and $14 PT
(212) 527-3557
mthibault@btig.com Helius has the potential to help people with traumatic brain injuries to
regain normal function, balance, and the ability to walk.
Andrea Alfonso
(212) 527-3565 improvement in patients with no other good options. Helius’s
Major
aalfonso@btig.com data shows significant improvement in balance and function in
patients with traumatic brain injury who have stopped progressing
with physical and cognitive therapy. We are not aware of other non-
invasive options available to this group who endure long-term
disability and suffering.
HSDT $11.11 Three compelling and large markets. Helius will target workers’
12 month target
Upsi de
$14.0024.6%
comp, the military, and normal medical insurers. All are multibillion
dollar markets and there are compelling financial benefits for the first
BUY two as workers’ comp may decrease long-term payments and the
52 week range $6.90 - $19.92 military will be able to return highly skilled, valuable soldiers to the
Dividend
Market Yield
Cap (m) $230 field.
Price Performance be a great media story. We cannot think of many stories that
Should
have more positive public sentiment than helping an injured soldier
regain function and the ability to walk. We expect various media
outlets to pick up on this and help drive adoption and reimbursement.
we see significant upside we also feel there are two risks that
While
need to be mentioned. 1) Helius missed its primary efficacy endpoint
and the FDA could ask for more data. We find this unlikely since both
the high-frequency and low-frequency pulse (control) groups
improved, falls and headaches improved, and there were no serious
adverse events, but the FDA can be unpredictable. 2) Helius’s need for
more capital is expected to occur around the time the FDA should
offer a response. Any FDA delay could make capital harder to obtain.
Source: IDC
Valuation: Our rating is Buy. Our $14 PT is based on a DCF, included
on page 21. Risks are discussed below.
Estimates
1Q17 A 2Q17 A 3Q17 A 4Q17 A FY17 A 1Q18 A 2Q18 E 3Q18 E 4Q18 E FY18 E FY19 E
Sales 0 0 0 0 0 0 0 0 0 0 5
Gross Margin (%) - - - - - - - - - - 78.3%
EBIT (5) (6) (6) (6) (23) (5) (5) (5) (5) (20) (35)
Net Income (6) (5) (12) (4) (26) (2) (5) (5) (5) (18) (35)
Diluted EPS (GAAP) (0.32) (0.31) (0.67) (0.19) (1.50) (0.08) (0.23) (0.23) (0.23) (0.75) (1.30)
Source: BTIG Estimates and Company Documents ($ in millions, except per share amount)
While the missed primary effectiveness endpoint in the registrational trial may
give some potential investors pause, we see the results as evidence of a strong
clinical response to any level of translingual noninvasive neuromodulation
stimulation (TLNS) and the fact that there were no serious adverse events and
falls and headaches improved should lead the FDA to approve the device. The
FDA is always unpredictable, but we feel it would be a major disservice to
these patients if the FDA delays approval for more data. Neuromodulation
device trials have a history of statistical significance being impacted by a
higher-than-expected response in a sham control arm. We feel FDA is aware of
this issue and will weigh the therapy’s safety against the mixed efficacy data to
grant the PoNS device 510(k) clearance.
If Helius is approved, we expect brisk adoption and strong growth given the
lack of any safety concerns and the seriousness of TBI.
The two biggest risks to this investment are that the FDA could ask for more
data due to the missed primary endpoint and the likelihood that FDA’s
expected response may occur around the time when we expect Helius to need
additional capital.
Reasons to Buy
Large market opportunity in a highly visible patient
population that has no other treatment options.
HSDT’s PoNS device will first be used to treat patients with chronic balance
deficit from mild-to-moderate traumatic brain injury (mTBI). There are
between 3.2-5.3 million people in the United States who have a disability from
TBI, according to the Centers for Disease Control and Prevention (CDC).
Medical literature reports that 30-65% of TBI patients have balance disorders
during recovery. If we estimate that approximately 40% of TBI patients suffer
from chronic balance deficit, this equates to a staggering 1.3-2.1 million
potential patient population, just in the United States. In addition, there were
2.8 million new TBI-related cases seen in the United States in 2013, according
to a Morbidity and Mortality Weekly Report published by the CDC. This is
another 1.1 million potential new patients each year (40%) for the PoNS
device’s first indication.
Management plans to first introduce the PoNS device to patients who are part
of workers’ compensation programs. A company-commissioned analysis by
L.E.K. Consulting found that 4% of patients with balance deficits due to mild or
The company’s initial commercial plan is to set pricing for the PoNS device and
accompanying therapy at ~$30,000 per patient. Using this price, we arrive at
an estimate of $2.5B (84,800 patients * $30,000) for the workers’
compensation market opportunity – a sizable potential first market for HSDT.
Even after removing the rehabilitation component, it is a multibillion dollar
market.
In addition to those patients who are hurt on the job, TBI-related balance
deficits are frequently experienced by members of the military and athletes at
all levels. In recent years, lawsuits, media attention, advocacy and outreach,
and scientific research have led to a brighter spotlight on traumatic brain injury
and its related side effects. This has led to increased visibility and awareness of
this vulnerable patient population.
Lastly, this targeted population has failed (not gaining further improvement
from) physical and cognitive therapy. They have no other meaningful
treatment options, which should lead to brisk adoption of the PoNS
treatment. We also think the military component will bring significant media
opportunities. An injured soldier regaining his or her ability to walk and
function normally is a heartwarming human interest story that should help
drive awareness and adoption of the treatment.
All the patients in the 122-patient trial had been injured at least one year prior
to entering the study, had undergone physical rehabilitation, and had seen the
improvement in their balance stall. Though the medical literature shows that
patients are often able to improve their SOT scores by ~8-10 points during
months of physical therapy, the benefit often recedes after physical therapy
ends.
In the PoNS trial, a patient was termed a “responder” if his or her SOT score
increased by more than 15 points. We find it impressive that 71.6% of patients
in both arms saw this level of functional improvement. Patients receiving
PoNS high-frequency pulse (HFP) stimulation experienced a mean SOT score
increase of 20.3 points after two weeks of HFP and physical therapy; the mean
Helius Medical’s management team has had discussions with FDA that point to
potential categorization as a Class II device, a lower risk classification than
Class III. In our view, the lack of side effects and the device’s strong safety data
should be a positive for the FDA’s risk-benefit consideration.
In the PoNS registrational trial for chronic balance deficit related to non-severe
TBI, the technology missed its primary efficacy endpoint because of a higher-
than-anticipated responder rate in the sham control arm. The sham control
arm was designed to deliver a low-frequency pulse and as has been seen in
other neuromodulation device trials, this low-frequency pulse had a clinical
effect on patients, much like a lower dose of a drug might still have a clinical
effect. After combining the two arms, the company found that 71.6% of
patients in the trial were responders to PoNS device therapy. This is
particularly impressive in a group of patients that had previously undergone
extensive physical therapy and were no longer seeing improvement in balance.
We believe the FDA is well aware of the issues around trial design for
neuromodulation devices. We think there is an ~85% chance that the agency
will clear the PoNS device after considering the technology’s impressive
efficacy and strong safety profile. Still, there is some risk around regulation.
Timing of a potential clearance is also unknown, and while we think it could
come near the end of 2018 (assuming 510(k) submission is in the second
quarter of the year or around mid-year), a delay of a few months is always a
possibility. Our model assumes a US launch during the first quarter of 2019.
Reimbursement risk.
Reimbursement is always a risk with medical devices, and Helius Medical does
not yet have third-party reimbursement in place. While we think the
company’s plan to contract with a few clinics before the PoNS device is cleared
by FDA may shorten the time between clearance and commercial coverage,
there is no guarantee that this will happen. In addition, while management
currently believes that an ASP of approximately ~$30,000 is appropriate for
the PoNS device, therapy, and other costs, this may not be feasible if
insurance payment is set significantly lower than expected. As with any
medtech product, there is a possibility that coverage is more restrictive or set
at a lower price than predicted; this would impact HSDT’s commercial outlook.
Valuation
Our HSDT rating is Buy. Our $14 price target is based on a DCF, assuming a
15% discount rate and a terminal EV/EBIT multiple of 16x. We selected this
terminal multiple after reviewing multiples for a microcap comp group. We
estimate an ~85% chance of FDA clearance, as the regulatory pathway is never
100% guaranteed, but we see the low-risk profile of the technology offsetting
any messiness in the data. Near term, we think shares will trade around an
FDA decision and quarterly reports once a commercial launch has begun.
We model $5M in revenue for the company’s first year of sales. We think Helius
may travel a similar path as Senseonics (Buy, $5 PT). Senseonics offers a
compelling, differentiated, minimally invasive technology that addresses a
very large market. SENS did about $6M in revenue in its first year of
commercialization. Senseonics stock came under pressure when its available
capital became a risk and as the FDA took a bit longer than expected to
schedule its panel, but now with a strong balance sheet and a positive FDA
advisory panel vote, has seen its market cap more than double to over $400M
in the past year or so. We could see Helius following a similar trajectory.
We estimate that there are at least 150 highly specialized clinics devoted to
neurorehabilitation in the United States. However, we believe that some
physical therapy centers will be willing adopters of the PoNS treatment. While
the treatment isn’t suited for every site, we think some portion of the several
thousand physical therapy centers in this country can develop a PoNS practice
and become a referral site for physicians and case managers.
Multiple sclerosis patients often suffer falls. Helius Medical has conducted a
feasibility study on the effect of PoNS treatment in patients with a chronic
balance and gait deficit from multiple sclerosis. That 14-patient study (7 active,
7 control) found a statistically significant improvement in SOT scores in the
patients who received PoNS treatment for 14 weeks (p<0.001) as well as
improvement in the five patients in the sham control arm who chose to return
for PoNS treatment.
Helius expects to conduct further clinical work for this indication, including
plans to secure an investigation device exemption (IDE) for a US registrational
trial. This trial could start as early as the second half of 2018, but depends on
capital and FDA go-ahead for the IDE.
Stroke:
The company is evaluating its plans for stroke studies using the PoNS device.
The technology may have potential in helping patients recover from stroke-
related disabilities.
Cognition:
The company may also eventually pursue other indications such as addiction,
Parkinson’s Disease, cerebral palsy, and more.
Company Overview
Helius Medical Technologies is a neuromodulation company poised to submit
its Portable Neuromodulation Stimulator (PoNS) device to the FDA for 510(k)
clearance. The technology behind the PoNS device originated at the Tactile
Communication and Neurorehabilitation Laboratory (TCNL) at the University
of Wisconsin-Madison. The researchers who expanded the science of
translingual neurostimulation and invented the PoNS device started Advanced
NeuroRehabilitation, LLC (ANR). ANR and MPJ Healthcare created
NeuroHabilitation Corporation as a joint venture in 2013 to bring the PoNS
device to market. Helius Medical Technologies acquired NeuroHabilitation
Corporation (NHC) via a reverse merger in 2014. The company went public on
the Toronto Stock Exchange in 2016 and also traded on the OTCQB until its
April 2018 uplisting to Nasdaq.
Helius has historically worked closely with the US Army. The company’s
subsidiary, NHC, signed a cooperative research and development agreement
(CRADA) with the US Army in February 2013 to study whether PoNS
technology could be commercialized to offer injured soldiers a clinical benefit
in TBI-related disorders like PTSD, pain, and tinnitus. In July 2015, NHC and the
The company’s relationship with the US Army may extend to future research
on additional indications with the PoNS device.
Products
The Portable Neuromodulation Stimulator (PoNS) Device and Therapy
Patients who are prescribed the PoNS device work with a physical therapist in
the clinic for two weeks, combining the translingual neurostimulation with
rigorous physical therapy. These two weeks are followed by 12 weeks of
independent therapy at home. The physical therapist can monitor the length
and strength of the patient’s treatment sessions. According to the company,
the device halts treatment after 14 weeks, but can be reset by the physical
therapist to continue treatment.
Exhibit 2: The PoNS Device
Balance was measured using the NeuroCom Sensory Organization Test (SOT).
Under the SOT protocols, patients stand on a balance system and their degree
of sway is measured in six scenarios involving various combinations of eyes
open or closed, a fixed surface or sway-referenced surface, and a visual
surround or sway-referenced visual surround. The SOT score is measured on a
scale of 0-100, with 0 being a person who cannot stand on their own and 100
being someone with perfect balance. A person scoring in the 70-80 range
would be able to function normally. At baseline entering the trial, the patients
in the PoNS registrational trial had an average SOT score of approximately 40.
The chart below from HSDT’s company presentation shows the SOT score
improvement in HFP patients at Week 2 and Week 5.
While a perfect data set would have been preferable, we believe the device
should be approved even though it missed the primary effectiveness endpoint.
Both stimulation groups improved after failing physical therapy alone, these
patients have a debilitating condition with no other real options, and the
device is safe. These patients have falls and headaches and the device not only
did not worsen these issues, it significantly improved them. In our minds it
would be irresponsible for the FDA not to approve this device, but as always,
the FDA can be unpredictable. Further, in the neuromodulation device field,
there is precedent for sham control arms that have a strong therapeutic effect.
One example of this is the ReCharge pivotal trial for EnteroMedics’ (since
renamed ReShape Lifesciences (RSLS, Not Rated)) VBLOC therapy using vagal
blocking therapy for obesity. That double-blind trial included a sham, inactive
device for the control arm. At 12 months in the intent-to-treat population of
239 patients, VBLOC patients experienced 24.4% average excess weight loss
while the sham control patients had 15.9% average excess weight loss. This
was a statistically significant difference (p=0.002) but did not meet the super-
superiority pre-specified 10% margin (p=0.705). In addition, the other co-
primary effectiveness endpoint required that at least 55% of VBLOC patients
reach at least 20% excess weight loss and at least 45% of VBLOC patients
reach at least 25% excess weight loss. The therapy missed this endpoint too,
with 52.5% of VBLOC patients and 32.5% of control patients achieving >20%
excess weight loss (p=0.004) and 38.3% of VBLOC patients and 23.4% of
control patients reaching >25% excess weight loss (p=0.02).
We believe the clear clinical benefit, unmet need, and low-risk profile of the
PoNS device makes FDA clearance highly likely.
Intellectual Property
According to Helius Medical’s latest 10-K filing, the company owns 25 US
patents, 15 foreign patents, and is the exclusive licensee of seven US medical
method patents via an agreement with Advanced NeuroRehabilitation (ANR).
ANR will be paid a 4% royalty on revenue related to these patents. These
seven licensed patents, issued between September 2014 and May 2017, cover
non-invasive neurostimulation through the mouth or through the skin, in
combination with physical therapy, cognitive therapy, exercise or “stimulation
of the . . . vision, hearing, vestibular systems, or somatosensory systems” to
treat “various maladies.” These medical method patents seem to provide a
broad base protecting the PoNS device treatment in any number of diseases
and for other types of non-invasive neurostimulation.
The 25 US patents (nine utility patents and 16 design patents) and the 15
foreign patents (four utility and 11 design patents) cover specific details of the
PoNS mouthpiece and controller, as well as manufacturing methods and
alternative designs for the mouthpiece and controller.
In addition to these issued patents, there are several patents pending in the US
and outside the US. There are also three Chinese design patents that have
been transferred to China Medical Systems Holdings LTD as part of the
company’s development and marketing agreement with A&B (HK) Limited
(see the “Sales, Manufacturing, and Marketing” section below for more).
Reimbursement
There is not yet an established reimbursement pathway for the PoNS
treatment. Helius Medical plans to try to attain reimbursement coverage for
the PoNS device and accompanying therapy. Since the company’s first target
market is the WC patient population, a first step toward broader payer
coverage will be to contract with the payers and third-party administrators
(TPAs) that specialize in the WC population.
Helius is also likely to target the US military through both the active and VA
systems. The active system is likely to pay faster as there is considerable cost
in training soldiers who are then no longer able to work. While some may make
it back to the battlefield, others who experience clinical improvement may be
able to work in military training, recruitment, or office jobs. Longer term, we
HSDT has not detailed its initial plans for the size of a commercial salesforce,
but we anticipate the company will ramp up hiring – and thus SG&A spend –
around the time of launch. However, the company is planning to implement an
investigational device clinical experience program (CEP) with at least four
clinics before regulatory clearance and commercial entry. This should help the
company gain key learnings as it approaches market launch into the workers’
compensation market, potentially as early as the fourth quarter of 2018. The
company anticipates offering training for physical therapists, PoNS
Certification Designation for clinics, and may potentially offer geographic
exclusivity to early adopters.
Outside the United States, the company may hire sales reps in some
geographies and partner in other countries. For instance, A&B (HK) Company
Limited is an exclusive partner for development and sale of the PoNS device in
China, Hong Kong, Macao, Taiwan, and Singapore, according to an agreement
announced in October 2015.
Management
Philippe Deschamps, President, Chief Executive Officer, and Chairman: Mr.
Deschamps joined the company in 2013. He has spent more than 30 years with
healthcare and pharmaceutical companies. Before Helius, Mr. Deschamps was
CEO of MediMedia Health Market Services. Prior to that role, he was President
and CEO of GSW Worldwide, a division of inVentiv Health. Earlier in his career,
Mr. Deschamps was Director of Neuroscience Marketing at Bristol-Myers
Squibb. Mr. Deschamps earned a degree in Chemistry from the University of
Ottawa.
Joyce LaViscount, Chief Financial Officer and Chief Operations Officer: Ms.
LaViscount was a member of Helius Medical’s Board of Directors from March
2015 to December 2015 and became the company’s CFO and COO in October
2015. She has almost 30 years of experience in the health sciences industry.
Before joining Helius, Ms. LaViscount was COO and CFO for MM Health
Solution; during part of her tenure there, she was also CFO for MediMedia
Pharmaceutical Solutions. Before those roles, she was Executive Director and
Group Controll North America at Aptalis Pharmaceuticals. Earlier in her career,
Ms. LaViscount was in leadership roles at Endo Pharmaceuticals and spent
many years at Bristol-Myers Squibb and Pharmacia. Ms. LaViscount is a
Certified Public Accountant and earned a degree in Business with a
concentration in Accounting from Franklin and Marshall College before
starting her career at Ernst & Young.
Jonathan Sackier, Chief Medical Officer: Dr. Sackier became Helius Medical’s
CMO in December 2014. He has more than 30 years of experience in the
healthcare field. With his background as a surgeon, Dr. Sackier has been part
of the development of numerous medical technologies and healthcare
companies, including the AESOP robot for Computer Motion (which later
merged with Intuitive Surgical). He has worked with many major medical
device and pharmaceutical companies, such as Stryker, Siemens, Bayer,
Novartis, Karl Storz, Pfizer, Applied Medical, and ConvaTec. Dr. Sackier
started the Washington Institute of Surgical Endoscopy, and was also a Clinical
Professor at George Washington University and a Visiting Professor of Surgery
at University of Virginia. He also serves or has served on several boards within
the healthcare field.
Competition
The PoNS device will likely be the first non-invasive technology to address
chronic balance deficits related to TBI. We are not aware of any direct
competitors nearing commercialization. However, there are several indirect
In other clinical areas that Helius may target in the future, there are a variety of
competitors. While we are not going to extensively document all areas of
neuromodulation, it is fair to say that there are many devices and drugs
targeting various diseases such as headache, pain, diabetes, depression,
Parkinson’s, epilepsy, etc. The brain is complex and is an area of medicine
seeing significant investment and research focus.
Model Assumptions
Our HSDT revenue model is based on patients prescribed to PoNS treatment
and the number of centers offering PoNS treatment. We assume a US launch
at three centers starting in the first quarter of 2018, ramping to 14 US centers
by the end of 2019, 29 centers at the end of 2020, 43 sites in 2021, 60 programs
in 2022, and 79 centers by the end of 2023. We expect the number of patients
added at each center to increase as programs become more established. We
assume an OUS launch starting in the fourth quarter of 2019. We model a
slower international ramp, given the potential for a distributor model. Our
model assumes that patients receive one 14-week course of PoNS treatment.
We want to wait to observe real-world prescribing trends before building
repeat treatments into our forecast. Repeat prescriptions represent upside to
our model. Our forecast assumes a PoNS device ASP of $18,000 in the US and
a $15,000 price outside the US to account for a distributor model.
For the first full year of commercialization in the US, we estimate ~$5M in
revenue. This represents ~260 patients prescribed to PoNS treatment during
the period.
We expect gross margins on PoNS device revenue to be high relative to other
medtech companies. We model gross margins in the high-70s in the early
quarters of launch, climbing to the mid-80s in 2022 and beyond. We do expect
operating expenses outpace revenue for a few years, as the company
continues to invest in its indication pipeline and builds its commercial
salesforce. We model profitability starting at the end of 2023, but admit that
there are numerous factors that impact this timeline.
We model average cash burn of ~$5M in 2018, stepping up to ~$9M in 2019. At
this rate, we expect four more share raises over the time horizon of our model,
though we do not have any insight into how future financings might be
structured. We model a $35M raise in the first quarter of 2019, followed by a
$50M raise in the fourth quarter of 2019, another $50M in the first quarter of
2021, and finally another $50M in the first quarter of 2023.
Margin Analysis FY1 5 A FY1 6 A FY1 7 A 1Q18A 2Q18E 3Q18E 4Q18E FY1 8 E 1Q19E 2Q19E 3Q19E 4Q19E FY1 9 E 1Q20E 2Q20E 3Q20E 4Q20E FY2 0 E FY2 1 E FY2 2 E FY2 3 E
Gross Profit Margin NM NM NM NM NM NM NM NM 77.8% 77.8% 78.3% 78.5% 78.3% 79.1% 79.8% 80.2% 80.7% 80.1% 82.1% 84.4% 86.2%
EBIT Margin NM NM NM NM NM NM NM NM -3070.4% -1139.2% -636.9% -370.8% -712.2% -279.2% -226.5% -177.8% -153.6% -198.1% -87.3% -35.6% -4.7%
Pre-tax Income NM NM NM NM NM NM NM NM -3070.4% -1139.2% -636.9% -370.8% -712.2% -279.2% -226.5% -177.8% -153.6% -198.1% -87.3% -35.6% -4.7%
Effective Income Tax Rate NM NM NM NM NM NM NM NM 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0%
Adjusted Net Income NM NM NM NM NM NM NM NM -3070.4% -1139.2% -636.9% -370.8% -712.2% -279.2% -226.5% -177.8% -153.6% -198.1% -87.3% -35.6% -4.7%
Expenses (% of Revenue) FY1 5 A FY1 6 A FY1 7 A 1Q18A 2Q18E 3Q18E 4Q18E FY1 8 E 1Q19E 2Q19E 3Q19E 4Q19E FY1 9 E 1Q20E 2Q20E 3Q20E 4Q20E FY2 0 E FY2 1 E FY2 2 E FY2 3 E
Cost of Revenue NM NM NM NM NM NM NM NM 22.2% 22.2% 21.7% 21.5% 21.7% 20.9% 20.2% 19.8% 19.3% 19.9% 17.9% 15.6% 13.8%
SG&A NM NM NM NM NM NM NM NM 1481.5% 595.2% 368.1% 240.7% 399.3% 197.3% 178.1% 154.4% 143.5% 163.4% 107.4% 78.4% 60.9%
Research & Development NM NM NM NM NM NM NM NM 1666.7% 621.7% 347.2% 208.6% 391.2% 160.9% 128.2% 103.6% 90.9% 114.7% 62.1% 41.6% 29.9%
Total Operating Expenses NM NM NM NM NM NM NM NM 3148.1% 1216.9% 715.3% 449.3% 790.5% 358.2% 306.3% 258.0% 234.3% 278.2% 169.5% 120.0% 90.9%
Y/Y Growth FY1 5 A FY1 6 A FY1 7 A 1Q18A 2Q18E 3Q18E 4Q18E FY1 8 E 1Q19E 2Q19E 3Q19E 4Q19E FY1 9 E 1Q20E 2Q20E 3Q20E 4Q20E FY2 0 E FY2 1 E FY2 2 E FY2 3 E
Revenue NM NM NM NM NM NM NM NM NM NM NM NM NM 1120.0% 457.1% 268.8% 151.6% 284.9% 100.0% 63.7% 49.7%
Cost of Revenue NM NM NM NM NM NM NM NM NM NM NM NM NM 1049.8% 406.3% 236.7% 125.4% 253.1% 79.5% 43.0% 32.4%
Gross Profit NM NM NM NM NM NM NM NM NM NM NM NM NM 1140.1% 471.7% 277.6% 158.8% 293.8% 105.1% 68.2% 52.9%
SG&A NM NM NM NM NM NM NM NM NM NM NM 140.0% 104.9% 62.5% 66.7% 54.7% 50.0% 57.6% 31.4% 19.5% 16.3%
Research & Development NM NM NM NM NM NM NM NM NM NM NM 89.1% 81.3% 17.8% 14.9% 10.0% 9.6% 12.9% 8.2% 9.7% 7.7%
Operating Expenses NM NM NM NM NM NM NM NM NM NM NM 113.3% 92.5% 38.8% 40.2% 33.0% 31.3% 35.5% 21.8% 15.9% 13.3%
Source: BTIG estimates and company reports
US Market
Cumulative Patients 0 0 0 0 0 15 57 137 263 263 416 605 830 1,091 1,091 2,581 4,924 8,344
Patient Adds 0 0 0 0 0 15 42 80 126 263 153 189 225 261 828 1,490 2,343 3,420
y/y growth NM NM NM NM NM NM NM NM NM NM 920.0% 350.0% 181.3% 107.1% 214.8% 80.0% 57.2% 46.0%
Repeat Patients 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Number of Centers Offering PoNS Treatment 0 0 0 0 0 3 6 10 14 14 17 21 25 29 29 43 60 79
Avg. Number of Patient Adds/Center in qtr. NM NM NM NM 5 7 8 9 9 9 9 9
PoNS Device Units Sold 0 0 0 0 0 15 42 80 126 263 153 189 225 261 828 1,490 2,343 3,420
PoNS Device Pricing ($s) 18,000 18,000 18,000 18,000 18,000 18,000 18,000 18,000 18,000 18,000 18,000 18,000 18,000 18,000 18,000 18,000 18,000 18,000
PoNS Device Revenue ($m) 0.0 0.0 0.0 0.0 0.0 0.3 0.8 1.4 2.3 4.7 2.8 3.4 4.1 4.7 14.9 26.8 42.2 61.6
O US Market
Cumulative Patients 0 0 0 0 0 0 0 0 15 15 51 105 189 294 294 1,051 2,405 4,537
Patient Adds 0 0 0 0 0 0 0 0 15 15 36 54 84 105 279 757 1,354 2,132
y/y growth NM NM NM NM NM NM NM NM NM NM NM NM NM 600% 1760% 171% 79% 57%
Repeat Patients 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Number of Centers Offering PoNS Treatment 0 0 0 0 0 0 0 0 3 3 6 9 12 15 15 29 45 61
Avg. Number of Patient Adds/Center in qtr. NM NM NM NM NM NM NM 5 6 6 7 7
CO Gs
Total PoNS Devices Sold 0 0 0 0 0 15 42 80 141 278 189 243 309 366 1,107 2,247 3,697 5,552
PoNS Device Costs 4,000 4,000 4,000 4,000 4,000 4,000 4,000 3,900 3,800 3,925 3,650 3,500 3,400 3,300 3,463 3,050 2,650 2,331
Total PoNS Device COGS 0.0 0.0 0.0 0.0 0.0 0.1 0.2 0.3 0.5 1.1 0.7 0.9 1.1 1.2 3.8 6.8 9.7 12.9
Revenue $0 $5 $19 $38 $62 $94 $131 $169 $203 $223 $231
y/y change (%) Step -10% 285% 100% 64% 50% 40% 30% 20% 10% 4%
Taxes 20.0% 0 0 0 0 0 0 2 6 12 18 19
Period 0.00 0.75 1.75 2.75 3.75 4.75 5.75 6.75 7.75 8.75 9.75
Factor 1.00 0.90 0.78 0.68 0.59 0.51 0.45 0.39 0.34 0.29 0.26
Regulatory Disclosures
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BTIG LLC has received compensation for investment banking services in the past 12 months from:
Helius Medical Technologies, Inc (HSDT)
BTIG LLC had an investment banking services client relationship during the past 12 months with:
Helius Medical Technologies, Inc (HSDT)
BTIG LLC managed or co-managed a public offering of securities in the past 12 months for:
Helius Medical Technologies, Inc (HSDT)
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