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#Trading Halt - trading update
Added a month ago

place your bets… trading better or worse than previously expected…



Market Announcement

27 March 2024

27 March 2024 Market Announcement 1/1

ASX Limited ASX Customer Service Centre 131 279 | asx.com.au

#10709173v1

SomnoMed Limited (ASX: SOM) – Trading Halt

Description

The securities of SomnoMed Limited (‘SOM’) will be placed in trading halt at the request of SOM, pending it

releasing an announcement. Unless ASX decides otherwise, the securities will remain in trading halt until the

earlier of the commencement of normal trading on Tuesday, 2 April 2024 or when the announcement is

released to the market.

Issued by

ASX Compliance

27 March 2024

Listings Compliance ASX Limited

Email: tradinghaltssydney@asx.com.au

Dear Sir/Madam,

SomnoMed Limited ACN 003 255 221 (ASX:SOM) – Request for trading halt

SomnoMed Limited (Company) requests ASX grants an immediate trading halt of its securities pursuant to ASX

Listing Rule 17.1.

The Company provides the following information for the purposes of ASX Listing Rule 17.1:

• The trading halt is requested pending the Company making an announcement regarding a trading update and

earnings guidance.

• The Company requests the trading halt remain in place until the earlier of the Company making the

announcement referenced above, or commencement of trading on Tuesday, 2 April 2024.

• The Company expects that release of the announcement referenced above will end the trading halt.

• The Company confirms that it is not aware of any reason why the trading halt should not be granted or of any

other information necessary to inform the market about the trading halt.

Terry Flitcroft

Company Secretary

SomnoMed Limited

#ASX Announcements
stale
Added 2 years ago

Strong growth!!! Loving that America is growing so strongly 30% excluding currency effects


 25 October 2022

North America’s Q1 revenue growth leads the way

SomnoMed Limited (ASX “SOM”, or the Company), a leading company in the provision of oral appliance treatment solutions for sleep-related breathing disorders and obstructive sleep apnea (‘OSA’), is pleased to provide its quarterly activities report for the period ended 30 September 2022 (Q1 FY23).

Financial Highlights

• Q1 FY23 revenue of $18.5 million, up +19% (+21% in constant currency) versus the previous corresponding period (pcp)

• North America Q1 FY23 revenue of $7.3 million, up +44% (+33% in constant currency) versus pcp, demonstrates strong sales momentum in the region driven by best-in-class products and service

• The strong group quarterly performance versus pcp reflects the impact of the sales and marketing initiatives in all regions and the trend of growing patient and medical clinician adoption of Continuous Open Airway Therapy (“COATTM”) for the treatment of OSA

• SomnoMed’s FY23 guidance, including +20% revenue growth, remains unchanged

• Available cash of $12 million as at 30 September 2022, sufficient to fund growth opportunities and the development of Rest Assure® with a further $6 million of the new debt funding arrangement to be drawn down towards the end of Q2 FY23

Operational Highlights

• The Company hosted the second annual SOM Summit which brought together the leading Sleep Medicine practitioners from North America and globally to drive awareness and education of COATTM for the treatment of OSA

• Total patients treated worldwide now exceeds 740,000

• Development of Rest Assure®, the Company’s first ever in-built technology-enabled oral appliance, remains on schedule with the focus on the preparation of documentation required for regulatory submissions

• The Company continues to proactively deliver on a range of initiatives to secure our supply chain with the aim of limiting any negative impact of inflation pressure on margins

Commenting on the results, SomnoMed’s Managing Director, Mr Neil Verdal-Austin said: “The September quarter saw the Company deliver financial growth in line with guidance, increase the awareness of COATTM for the treatment of OSA and progress the development of our technology-enabled oral appliance, Rest Assure®.”

“Whilst the Northern Hemisphere summer represents a seasonally lower revenue quarter in Q1, total group revenue was up 19% year on year. Our strong sales results and growing level of patients treated validates our Medical InitiativeTM strategy and confirms that the exceptional ‘first time fit’ quality and durability of our product range is superior and preferred by clinicians and patients world-wide for the treatment of mild to moderate OSA.”


Financial Review

Q1 FY23 revenue of $18.5 million, up +19% (+21% in constant currency) versus pcp reflects the growing demand for our COATTM technologies, AVANTTM and Herbst Advance EliteTM, and the investment the Company has made into sales teams and business development channels in all regions.

     Revenue (A$000's)

Q1 FY23

Q1 FY22

% Change

% Change

    (A$000’s)

(A$000’s)

Actual

Constant Currency

   North America

 Europe

 APAC

 Total group revenue

 7,345 9,679 1,529 18,553

5,105 +43.9% 9,308 +4.0% 1,167 +31.0% 15,580 +19.1%

+33.4% +12.3% +32.6% +20.8%

        Cashflow from operations was negative $1.9 million after excluding one-off payments relating to annual license fees and bonuses. Cash investments in R&D were mainly related to the Rest Assure® technology of c.$1 million. The Company maintains the forecast for FY23 EBITDA1 of at least $2 million and a CAPEX investment of c.$7 million, which includes expected technology innovation spend of c.$3 million.

SomnoMed remains well funded to execute on our growth priorities with available cash of $12 million as at 30 September 2022, and a further $6 million of the new debt funding arrangement to be drawn down towards the end of Q2 FY23.

Operational Review

Business conditions continued to improve across SomnoMed’s key regions of North America, Europe and Asia Pacific as the impacts of COVID-19 on the medical sector and broader dental community continued to reduce.

SomnoMed’s position within the OSA market remains strong, with the potential to further increase the addressable market by providing an alternative to the traditional default CPAP recommendations by most sleep physicians.

SomnoMed’s “treatment focused” part of our mantra ensures our commitment to provide a best-in-class, durable oral appliance for the treatment of OSA. The Company has continued to experience positive engagement within the medical sector, which is driving further acceptance of COATTM.

During the quarter, the Company continued to proactively deliver on a range of initiatives to secure our supply chain with the aim to limit any negative impact of inflation pressure on our cost structures to protect margins and cash flow.

North America

The North America market experienced another positive quarter with revenue up +44% (+33% in constant currency) versus pcp, driven by increased investment in sales and marketing efforts in the region driving demand for the product range, especially the AVANTTM and Herbst Advance EliteTM.

The direct impact of the Medical InitiativeTM continues to validate the Company’s strategic direction. The additions made to both the business development team and account management personnel indicate the depth and strength that the Company has over its competitors in integrity, value-based sales methodologies across both the medical and dental communities.

 1 EBITDA as adjusted does not include share-based payments, discontinued operations, and other expenses


Europe

 Revenue for the quarter was up +4% (+12% in constant currency) versus pcp. Patient demand for the Company’s COATTM technology remains strong across core countries within Europe, driven by strong positive reimbursement trends and a growing acceptance of the benefits of oral appliances for mild and moderate OSA patients. An investment was made this quarter in sales training across the region involving a strategic methodology approach to solution selling which is informed by our customer needs.

Asia Pacific

Asia Pacific quarterly revenues were up +31% (+33% in constant currency) versus pcp. This region has returned to deliver impressive growth for the quarter while continuing with its clinical education program and the investment in new sales and marketing resources to advance the adoption of oral appliances within the medical sector.

Rest Assure®

SomnoMed introduced Rest Assure®, its first ever in-built technology-enabled oral appliance, in February 2022. Rest Assure is designed to address the lack of overnight monitoring and objective data in COATTM, which has been a major barrier to prescription and reimbursement rates to date.

This innovative technology underpins the “technology driven” part of our mantra. The second patient validation study has been completed and the results are currently being analysed by the principal investigators. The Rest Assure® project remains on schedule, with SomnoMed’s focus now on the preparation of documentation required for regulatory submissions to the FDA (USA), TGA (Australia) and for CE marking (Europe). Rest Assure® will be commercialised once these approvals are received.

SOM Summit 2022

During the quarter, SomnoMed was proud to host and partner the second annual SOM Summit, a conference that brings together the leading Sleep Medicine practitioners from North America and globally. The summit is a key pillar in the awareness and education process for delivering COATTM for the treatment of OSA, allowing SomnoMed to further develop relationships within the medical field that will build on the Medical InitiativeTM strategy and to “treat more patients more effectively”.

---ends---

This release has been approved by the Board of SomnoMed Limited.

For further information please contact

 Corporate

Mr. Neil Verdal-Austin

CEO SomnoMed

+61 406 931 477 Nverdal-austin@somnomed.com

About SomnoMed

Investors

Mr. Craig Sainsbury

Automic Markets

+61 428 550 499 Craig.sainsbury@automicgroup.com.au

SomnoMed is a public company providing treatment solutions for sleep-related breathing disorders including obstructive sleep apnea, snoring and bruxism. SomnoMed was commercialised on the basis of extensive clinical research. Supporting independent clinical research, continuous innovation and instituting medical manufacturing standards has resulted in SomnoDent® becoming the state-of-the-art and clinically proven medical oral appliance therapy for more than 740,000 patients in 28 countries. For additional information, visit SomnoMed at http://www.somnomed.com.au

 

#Efficacy
stale
Added 2 years ago

So I've had a look through the articles attached to Somnomed's website @Strawman

Disclaimers: I'm a an anaesthetist so OSA is an important issue in my work but I'm no sleep specialist.


That said, from my perspective:

Clinically:


CPAP is absolutely the standard of care as acknowledged by everyone in the discussion.

I am seeing occasional patients who use an Oral Airway Device in place of CPAP. I will ask them why from now on out of interest.

The evidence:

I didn't complete a literature review outside of the evidence attached to the Somnomed website (If I was reviewing this as a clinician I absolutely would as it's important to see all the evidence).

Generally speaking doctors look at industry sponsored studies with scepticism and I note that some of the studies at least involve monetary donations in addition to supply of the products (although in this respect Resmed supplying CPAP machines and Somnomed supplying OADs seem to cancel eachother out).


Prospective Randomised Control Trials are the gold standard in medical research. I was surprised to find the number of CPAP vs OAD RCTs that have been done. In general they demonstrate that CPAP is more effective in reducing Apnoeas and Hypopnoeas (Ie pausing breathing altogether or reduction in ventilation to a low level). Interestingly the Australian Study in 2013 included moderate - severe OSA patients and didn't demonstrate any real difference between the two (they suggested that a balance was struck between the increased effectiveness of CPAP with the better adherence of OAD that in the end leads to pretty equivalent therapy).


The review article published 2014 is a good summary of the literature (until 2014).


If I get time I will do a lit review of the more recent literature but I've answered my original question, which was simply 'is there evidence that OADs actually improve AHI in CPAP patients (the health benefits generally are all assumed to flow from this)?


The answer, there is good quality evidence to support their effectiveness. Very reassuring. Now hold IRL.


#Efficacy
stale
Added 2 years ago

I’ve just caught up with the interview between @Strawman and Neil (CEO).


great interview and really enjoyed it. It’s hard not to be impressed and excited about the opportunity.


I will listen to Michael’s presentation when I get the chance and apologies if the answers are therein but the one question the strawman interview left me with was efficacy.

As a doctor I hold PAR with conviction that their drug zilosul has efficacy based on clinical studies and monitoring of effects in Patients who’ve been able to access the drug through the special access scheme in Australia.


is their trial evidence to support the efficacy of oral devices in osa? Have they been show to reduce the apnoea hyponoea index when used with good adherence? What level of evidence exists to support their use? I guess hearing the emphasis on obtaining data was great to hear but made me wonder whether the basis for the devices has been established?


may be way of base here and perhaps this was all assumed prior knowledge


Gaz