The S&P/ASX 200 Health Care Index (ASX: XHJ) is down more than 20% in that span. 

The sector has struggled to break out of its multi-year downgrade cycle, weighed down by negative consensus earnings revisions from index heavyweights. 

However, there are now buy-low opportunities according to experts. 

In a recent report, Canaccord Genuity said this backdrop presents an attractive risk/reward for the sector. 

"After a challenging period for Healthcare returns, valuations across the sector have become increasingly attractive. At the index level, the ASX 100 Healthcare sector now trades at two-decade lows on a relative P/E basis."

Here are two ASX healthcare shares with big upside according to brokers. 

Anteris Technologies Global Corp (ASX: AVR)

Anteris Technologies is a structural heart company. It researches, develops, commercialises, and distributes various medical technologies and devices. 

It manufactures, distributes, and sells ADAPT & DurAVR regenerative tissue products, and researches and develops regenerative medicine and immunotherapies.

This ASX healthcare stock is down more than 19% over the last 12 months, but has begun to recover from yearly lows. 

Recently, Bell Potter raised its price target to $13 (from $10), along with retaining a speculative buy rating. 

The broker has optimism around its future thanks to progress in getting its DurAVR product approved. 

The product uses a single-piece, native-shaped biomimetic design built to mimic the performance of a healthy aortic valve.

Based on yesterday's closing price of $8.86, this Bell Potter price target indicates potential upside of almost 47%. 

Telix Pharmaceuticals Ltd (ASX: TLX)

Another ASX healthcare stock tipped to recover is Telix Pharmaceuticals. 

It is a commercial-stage biopharmaceutical company focused on the ongoing development of diagnostic and therapeutic ('theranostic') products using targeted radiation.

Its share price has fallen almost 60% over the last year; however, experts are anticipating a bounce back. 

A key announcement earlier this week saw the ASX healthcare stock price jump considerably, which could be the beginning of a long-term recovery. 

On Monday, the share price rocketed 9% higher after the company released encouraging Part 1 results from its global Phase 3 ProstACT study of TLX591-Tx, its novel prostate cancer therapy. 

Results showed the therapy demonstrated an acceptable and manageable safety profile, with no new safety signals and sustained tumour uptake across patients.

The team at Jarden currently have a $21 price target on Telix shares.

Meanwhile, Morgan Stanley has a $24.60 price target. 

Based on yesterday's closing price of $10.76, these targets indicate an upside of 95% to 129%. 

The post Should you buy low on these ASX healthcare stocks? appeared first on The Motley Fool Australia.

That's because it believes the speculative stock could generate very big returns over the next 12 months if everything goes to plan.

Which ASX biotech stock?

The stock in question is Anteris Technologies Global Corp (ASX: AVR).

It is developing the DurAVR device, a class III medical device in the class of transcatheter aortic heart valves used for the treatment of severe aortic stenosis.

Bell Potter notes that the condition affects ~12 million people globally with an estimated ~150,000 procedures completed each year via the minimally invasive TAVR (transarterial valve replacement) procedure.

What is the broker saying?

Bell Potter notes that the ASX biotech stock is making a lot of progress towards getting its DurAVR product approved. It said:

Anteris continues to make excellent progress towards approval of the DurAVR by virtue of the recent opening of the Investigative Device Exemption (IDE) in the US followed by the US$320m capital raise to fund the pivotal study.

Any suggestion that DurAVR is not a serious a threat to the market leaders in the TAVR space should now be extinguished. The opening of an IDE is a seriously impressive achievement for any company, let alone AVR with no significant history at the FDA and no previous product approval. Secondly, the $90m placement (included in the $320m) to Medtronic (MDT) provides it with an effective right of last refusal on future M&A. It also amounts to a validation of the multiple features with the DurAVR technology which make it an appealing alternative to both the Edwards Life Science SAPIEN or the Medtronic's Evolut and CoreValve TAVR devices. AVR represents Special Value for MDT, which is now well positioned for a potential acquisition.

Big potential returns

According to the release, the broker has retained its speculative buy rating with an improved price target of $13.00 (from $10.00).

Based on its current share price of $8.76, this implies potential upside of 48% for investors over the next 12 months.

Commenting on its recommendation, the broker said:

The opening on the IDE and completion of the funding round substantially de-risk the pathway to approval and subsequent revenue stream. The key risk now remains the not insignificant task of successful completion of the phase 3 trial. Being a medical device of a mechanical nature, the certainty of outcome from the trial is far higher than for a drug as evidenced by data from the ongoing clinical program. As the path to revenue is substantially de-risked, our valuation is increased from A$10 to A$13 and we maintain our Buy (Speculative) rating.

The post Broker says this exciting ASX biotech stock could rise almost 50% appeared first on The Motley Fool Australia.

Anteris said in a statement to the ASX on Friday that it had raised US$320 million through the issue of new shares at US$5.75 per share.

The raise will bolster the company's size by more than 60%, with the $467 million raise in Australian dollar terms larger than its ASX value of $370 million and its NASDAQ listing of $394 million.

Key partner on board

Of this new raise, US$90 million was stumped up by Medtronic Plc (NYSE: MDT), which Anteris said was the world's largest medical technology company.

The smaller company said in its statement:

Anteris and Medtronic are aligned around the belief that reshaping the Transcatheter Aortic Valve Replacement (TAVR) market requires advancing clinical science and valve design while maintaining rigorous standards for durability, hemodynamics, and long‑term patient outcomes.

Anteris Chief Executive Officer Wayne Paterson said the investment from Medtronic and other investors was a strong vote of support for the company's plans.

This strategic investment, along with our underwritten offering of common stock, represent an important milestone for our company. It also provides strong validation of our program from the capital markets and a major strategic innovator. The investment is one aspect of a collaboration that may expand into other strategic areas in the future. Anteris has developed a clinically important, evidence-supported product designed to improve the lives of patients with aortic stenosis as we advance toward regulatory approval.

Clinical trial now well-funded

The funds raised will help Anteris complete the Paradigm clinical trial, which is evaluating the company's DurAVR THV System in comparison to commercially available transcatheter aortic valve replacement (TAVR) devices in patients with severe aortic stenosis.

Medtronic Vice President Jorie Sokin said Anteris was a recognised pioneer in the TAVR sector.

He added:

Our investment in differentiated innovation like the DurAVR THV technology — which has the potential to offer improved valve performance in a balloon-expandable platform — is core to our commitment to define and drive the future of TAVR, meeting the needs of more aortic stenosis patients and heart teams with a comprehensive portfolio.

While it was founded in Australia, Anteris said it also has a significant presence in Minneapolis, and "is a science driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients''.

Anteris shares were 5.5% higher in early trade at $9.40.

The post Heart tech firm's shares surge after huge capital raise appeared first on The Motley Fool Australia.

Trading will remain halted until the earlier of the company releasing an announcement to the market or the resumption of normal trading on Friday.

So, what's going on?

A large capital raising

The company is seeking to raise US$200 million through an underwritten public offering of common stock. On top of that, underwriters have the option to place an additional US$30 million in shares if demand is strong.

It's a huge capital raise, but investors will be particularly interested in the proposed investment by US medical device giant Medtronic (NYSE: MDT).

Medtronic steps in as a strategic investor

Alongside the public offering, Anteris has also agreed to a strategic private placement with Medtronic, one of the world's largest medical device companies.

Under the agreement, Medtronic is expected to invest up to US$90 million, which would ultimately allow Medtronic to own between 16% and 19.99% of Anteris following the capital raising (depending on final pricing and allocations).

Given Medtronic's scale and pedigree, investors will no doubt be interested in seeing how the two businesses can partner and ultimately grow the value of Anteris.

What will the money be used for?

According to Anteris, the funds raised will be used to support the next stage of growth of its structural heart business.

Key priorities include:

• advancing the DurAVR® Transcatheter Heart Valve global pivotal trial
• expanding manufacturing capabilities
• funding ongoing research and development, alongside general working capital

In short, the capital raise is designed to strengthen Anteris' balance sheet and fund its clinical and commercial ambitions.

When will trading resume?

The company has indicated that trading will resume once it issues an announcement detailing the outcome and pricing of the capital raising, or at the latest when the market reopens on Friday.

Until then, the trading halt ensures that the process can be completed without prejudices to investors who might have otherwise traded shares on incomplete information.

Anteris shares have had a tough time over the past 12 months, with the share price down 21% over that period.

The post Here's why Anteris shares are in a trading halt today appeared first on The Motley Fool Australia.

The company said in a statement to the ASX on Monday that it had received US Food and Drug Administration (FDA) approval to start its "Paradigm" trial, which is designed to evaluate the DurAVR Transcatheter Heart Valve (THV) in patients with "severe calcific aortic stenosis''.

Trial to collect key data

The trial will be a randomised controlled trial, evaluating the safety and effectiveness of the device compared to currently available options on the market.

As the company explained in its statement to the ASX:

This head-to-head study will enrol approximately 1000 patients across the Unites States, Europe and Canada … with 1:1 randomisation of patients who will receive either the DurAVR THV or transcatheter aortic valve replacements using commercially available and approved THVs. The Paradigm Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure.  

The trial is designed to provide "robust clinical evidence", which would then be used by the company to apply for premarket approval in the US.

Anteris chief executive Wayne Paterson said it was a key milestone for the company.

We are extremely pleased to receive FDA approval for the Paradigm trial, which allows us to commence patient recruitment in the United States. This milestone, together with the recent launch of the trial and first patients treated in Denmark, represents a significant achievement and a key step forward in advancing this life-saving technology worldwide for patients living with aortic stenosis, a debilitating and progressive condition.

The company said its device is the "first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow''.

Anteris Technologies was valued at $271.6 million at the close of trade on Friday.

The company's shares hit a high of $8.08 on the news on Monday morning before settling back to be changing hands for $7.90, up 11.7%.

Anteris shares have traded in a wide range over the past 12 months, from as low as $4.26 to as high as $13.36 in February.

The company's major shareholders include global investment fund L1 Capital, which holds an 18.7% stake. SIO Partners owns 9.6% of the company while Preceptive Life Sciences Master Fund owns 6.8%.

The post This small cap medical device maker's shares have surged on positive regulatory news appeared first on The Motley Fool Australia.

However, broker Bell Potter sees upside in two ASX healthcare shares that have fallen considerably over the last 12 months. 

Lets see what the broker had to say about these growth options.

Anteris Technologies Global Corp (ASX: AVR)

Anteris Technologies is a structural heart company, researches, develops, commercialises, and distributes various medical technologies and devices. 

The Company's lead product, DurAVR, is a transcatheter heart valve (THV) for treating aortic stenosis – a condition where the aortic valve becomes narrowed, restricting blood flow from the heart.

The last year has seen its share price fall almost 70%. At the time of writing this ASX healthcare share is trading at $5.60 a piece. 

However, broker Bell Potter sees it as a buy-low option with upside. 

The broker has a price target of $15.00, indicating an upside of 167.86%. 

The broker's speculative "buy" recommendation is largely based on the potential regulatory approval and commercial manufacturing of the DurAVR valve.

Management has released positive clinical trial updates this year, supporting its ongoing U.S. FDA approval pathway.

Following the recent IPO in the US, the next catalyst is the commencement of a pivotal study which we expect should lead to FDA approval and first commercial revenues in late 2028/2029.

Clarity Pharmaceuticals Ltd (ASX: CU6)

Clarity Pharmaceuticals is a clinical stage radiopharmaceutical company. It engages in research and development and clinical stage evaluation of its portfolio of novel radiopharmaceuticals products.

This ASX healthcare company has also seen its share price fall considerably in the last year. 

Its share price is down 45.58% in that span. At the time of writing, shares are trading at $2.77 each. 

However, Bell Potter sees upside in this speculative option. 

It currently has a price target of $5.20, indicating an upside of 87.73%. 

In May, the broker projected optimism in the company thanks to its strong cash position, which gives it enough funding to support key clinical programs until the second half of 2026, without needing to raise more capital right now.

Positive results for two major clinical trials could trigger commercial deals for the company's lead product, which is designed to detect smaller prostate tumours more accurately than current imaging products.

The first regulatory approval is expected by 2027. 

The post Two ASX healthcare shares that could be set to double appeared first on The Motley Fool Australia.

In fact, the two ASX healthcare shares listed below have just climbed to new highs. Here's why they are flying high today:

Anteris Technologies Ltd (ASX: AVR)

The Anteris Technologies share price climbed to a multi-year high of $19.92 on Friday. This brings its year to date gain to a sizeable 54%.

The catalyst for this recent gain has been the receipt of a confidential, non-binding proposal to merge with NASDAQ-listed special purpose acquisition company (SPAC) Medicus Sciences Acquisition Corp (MSAC). No financial terms have been revealed.

The release notes that MSAC currently has no commercial operations and was established as a blank cheque company for the purpose of effecting a merger, share exchange, or business combination with one or more businesses.

The SPAC appears to see potential in Anteris Technologies' DurAVR 3D single-piece aortic heart valve replacement product. Management notes that this product addresses the needs of tomorrow's younger and more active aortic stenosis patients by delivering superior performance and durability through innovations designed to last the remainder of a patient's lifetime.

Cronos Australia Ltd (ASX: CAU)

The Cronos Australia share price climbed 13% to hit a new 52-week high of 39.5 cents on Friday. When the cannabis company's shares reached that level, it meant they had almost doubled in value since the start of the year.

Investors have been bidding its shares higher in recent weeks thanks to a strong second quarter update last month. That update revealed cash receipts growth of 36% to $16.5 million for the quarter, which took its first half cash receipts to $28.5 million. This includes cash receipts from the CDA Health business, which it merged with at the end of last year.

Management described the merger with CDA Health as a "game changer for Cronos Australia and its shareholders."

The post 2 ASX healthcare shares bucking the trend to hit new highs on Friday appeared first on The Motley Fool Australia.

Anteris, formerly known as Admedus Ltd, is a medical company that focuses on designing and manufacturing heart valves. Its next-generation technology re-engineers xenograft tissue into pure collagen scaffold, helping surgeons replace values for patients during surgery.

At the time of writing, Anteris shares are roaring 18.24% higher to $10.50 after reaching a high of $10.90 earlier in the session. It's worth noting that in the past month alone, the company's shares have climbed 26% to a 6-month high.

Anteris successfully implants DurAVR valve

Investors are buying up Anteris shares after the company provided a positive announcement regarding its transcatheter aortic valve replacement (TAVR).

According to its release, Anteris advised it has successfully implanted the DurAVR value to five TAVR patients. The first-in-human study, carried out at the Tbilisi Heart and Vascular Clinic in Tbilisi, Georgia, showed great results.

No complications were detected among the five patients following their treatment. The trial assessed a number of performance and safety endpoints.

Anteris noted an additional five patients are planned for treatment in the first quarter of 2022 to conclude the study.

Anteris chief medical officer Dr Chris Meduri commented:

The meticulous preparation for this study has led to an outstanding set of results and patient outcomes. Not only did the valve performance exceed our very high expectations but the additional aspects of commissural alignment, flow characteristics and haemodynamics were proven to be clinically significant.

We are excited to now add more patients to our studies in 2022.

About the Anteris share price

On the back of today's incredible gains, the Anteris share price is up by 190% since this time last year. Anteris shares reached a 52-week high of $13.75 in March, before moving in circles for most of 2021.

Based on today's price, Anteris has a market capitalisation of roughly $95.13 million, with just 8.77 million shares on issue.

The post Anteris (ASX:AVR) share price soars 22% on successful human trial appeared first on The Motley Fool Australia.

The company's shares closed today's trade at $7.45, down 6.88%.

Anteris initiates capital raising

Anteris, a healthcare company specialising in the design and production of heart valve products, saw its share price fall after it announced a capital raise that will dilute existing shareholder value.

According to its release, Anteris advised it is placing 310,386 new ordinary shares mainly to its top 10 institutional shareholders.

The newly created shares will be offered at an issue price of $7.50 apiece, raising a total of $2.3 million.

The placement price represents a 9% discount to the 5-day volume weighted average price.

The shares will be issued using the company's existing placement capacity. Under listing rule 7.1, this allows up to 15% of its shares to be issued without shareholder approval.

In addition, participating investors will receive 1 unlisted option for every 2 shares, exercisable at $11.50 a pop.

The options will have a 2-year expiry period, and are subject to shareholder approval if they exceed listing rule 7.1.

Should shareholders vote against the issue of the options, the company will instead hand out a cash payment equivalent to $1.25 per option.

The vote will be held at Anteris' Annual General Meeting (AGM) in July.

The managers of the placement, Evolution Capital Advisors, will receive $81,739 for facilitating the capital raise.

Furthermore, there will be 50,000 options with the same terms available, pending shareholder approval. Again, should shareholders vote against, Anteris will pay a cash payment of $62,500 ($1.25 per option) to Evolution Capital Advisors.

About the Anteris share price

The Anteris share price is up just over 5% since this time last year.

Anteris shares reached a 52-week high of $13.75 in March, before treading lower due to profit taking and a broader market slump.

Based on today's price, Anteris has a market capitalisation of roughly $49 million, with only 6.6 million shares on issue.

The post Why the Anteris (ASX:AVR) share price backtracked 6% today appeared first on The Motley Fool Australia.

At the time of writing, the Anteris share price is up 5.5% to $9 per share.

Anteris Technologies is a healthcare company specialising in the design and production of heart valve and tissue products. It markets itself to investors as a structural heart company. In particular, delivering "clinically superior and durable solutions through better science and better design". Its focus is on developing next-generation technologies that help healthcare professionals create life-changing outcomes for patients.

After having sold the rights to its CardioCel and VascuCel patch products in 2019, the company's main focus today is on its Adapt BioScaffold products. In addition to the development of new heart valve replacement solutions. According to Anteris, the Adapt products are used across more than 135 medical centres globally.

In 2020, the company commenced human trials of its DurAVR heart valve.

Heart valve tech steps up

The company's milestone regards a specific technological component in its heart-valve artificial construction process called ComASUR. The company reports reaching concept lock on critical components of its ComASUR Transfemoral Delivery System. 

Most importantly, the novel commissural alignment component is now fully functional. This component gives physicians the ability to align the commissures of the replacement valve to the native valve.

This aspect of Transcatheter Aortic Valve Replacement (TAVR) delivery is not available with currently marketed products. However, it is highly desired by physicians.

A series of acute animal studies demonstrated the feasibility of the DurAVR THV (prosthetic aortic valve) and its bespoke ComASUR delivery system. The studies were specifically designed to show the ComASUR delivery system's ability to access the arterial vasculature. This uses minimally invasive techniques and tracks through the aortic arch to the aortic valve where a DurAVR THV was implanted.

The studies are a critical part of the test plans agreed with the FDA. This is a part of its approval process for the Company's Early Feasibility Study planned later in the year.

Anteris management comments

Anteris CEO, Wayne Paterson said the company's latest milestone was very positive.

This milestone is highly significant as we continue to innovate our product offerings. The commissural alignment component will give physicians the ability to deliver DurAVR accurately and consistently leading to better outcomes for patients. This further strengthens our three key technology pillars (ADAPT, DurAVR and ComASUR).

As we advance towards our FDA EFS submission, these milestones are critical to ensure study approval.

Anteris share price snapshot

The Anteris share price has been a disappointing performer on the ASX, losing more than 90% of its value over the past five years. The company has executed several capital raisings and has struggled with debt and cash flow issues.

However, since the beginning of 2021, the Anteris share price has more than tripled in value. Still far below its all-time highs of over $150, the Anteris share price has still gained 140% in 2021 so far.

The post Why is the Anteris (ASX:AVR) share price surging today? appeared first on The Motley Fool Australia.

At the time of writing, shares in the medical technology company are trading at $11.9, down 7.67%. By comparison S&P/ASX All Ordinaries Index (ASX: XAO) is down 0.14%.

Anteris, formerly known as Admedus Ltd, focuses on designing and manufacturing heart valves. Its next-generation technology re-engineers xenograft tissue into pure collagen scaffold, helping surgeons replace valves for patients during surgery.

What did Anteris announce today?

The Anteris share price is not responding well to today's positive news. In a statement to the ASX, Anteris reported its ADAPT treated tissue has "superior anti-calcification attributes compared with tissues used in competitor valves".

ADAPT is an anti-calcification treatment for human heart valves. Up to 20,000 people worldwide live with ADAPT technology inside their bodies.

According to Anteris, a review conducted by an independent biostatistician showed ADAPT-treated valve tissue had 38% calcium concentration compared to US company Medtronic's pig aortic valve. It also had 26% less calcium concentrate than Medtronic's cow aortic valve tissue. Porcine valve is used most commonly, but bovine valve is also used in valve replacement surgery.

According to the Mayo Clinic, aortic valve calcification is an early indicator of heart disease.

Words from the CEO

Commenting on the findings, Anteris CEO Wayne Paterson said:

These findings clearly demonstrated the superior performance of the ADAPT tissue engineered process as an anti-calcification technology against some of the top competitors in the marketplace.

It further supports previous human studies and clinical experience demonstrating ADAPT has a clinically relevant profile in terms of resisting calcification.

Anteris share price snapshot

The Anteris share price has shot up 168.53% over the last 12 months and surged an incredible 210.05% this year alone. 

On 9 March, the company was hit with a price query from the ASX to explain why its share price increased 79.97% over the space of just 10 days with no significant market announcements made during that time.

Anteris has a market capitalisation of $84.7 million.

The post Anteris (ASX:AVR) share price drops 7% despite positive announcement appeared first on The Motley Fool Australia.

Less than two weeks ago, the Anteris share price zoomed up 23% following the release of its latest investor presentation. The stock has been on the rise since the release of its most recent earnings, despite not being particularly impressive. However, the company did announce a number of capital raising exercises.

Here's a closer look at the latest we've learned about Anteris.

Anteris share price climbs off weak results

Anteris reported a 58% revenue fall for the period ended 31 December 2020 (FY20). Earnings before interest, tax, depreciation and amortisation (EBITDA) tumbled to a loss of $13.7 million.

The company's year-end cash balance was $4.4 million.

The business posted an FY20 net loss after tax of $15.3 million. Anteris advised that the loss is associated with expenses relating to the development of its DurAVRTM aortic replacement valve.

Funding grants and new FDA approval

Anteris was granted $2.3 million in government grants during FY20. The business further notes that it secured a funding package of up to $20 million with New York investment fund Mercer Street Global Opportunity Fund, LLC.

In December 2020, Anteris raised $1.1 million in a private placement to sophisticated investors as part of a broader funding package.

Additionally, Anteris believes that its obtainment of a US Food and Drug Administration (FDA) approval for its transcatheter aortic valve replacement (TAVR) product in younger patients will lead to growth.

ASX queries Anteris

Intraday trading volumes were double the five-day average yesterday as the Anteris share price pumped. Total volume finished the day at 77.9K.

This resulted in an ASX query to which the company responded today. The ASX letter also asked about the jump in share price from $6.64 on 25 February 2021 to yesterday's high of $11.95.

Anteris replied that it is not aware of anything that would be moving the market. The company also confirmed its compliance with all of the ASX listing rules.

The post The Anteris (ASX:AVR) share price is down today but has soared 150% in 3 months appeared first on The Motley Fool Australia.

The healthcare company opened the day at $5.85 and idled until an incredible rally just after midday shot the share price to $6.86. At the time of writing, Anteris shares have dipped slightly to $6.79.

What does Anteris do?

Anteris, formerly known as Admedus Ltd, is a medical company that focuses on designing and manufacturing heart valves. Its next-generation technology re-engineers xenograft tissue into pure collagen scaffold, helping surgeons replace valves for patients during surgery.

What did Anteris showcase in its investor presentation?

Wayne Paterson, CEO and Managing Director of Anteris, presented 3 technologies to investors that the company is working on.

The first and oldest is an anti-calcification treatment platform called ADAPT. In his presentation, Mr Paterson claimed up to 20,000 people around the world have ADAPT technology inside their bodies at present.

DurAVR was the second technology showcased. DurAVR stands for Durable Aortic Valve Replacement. Unlike other valve systems, which are made from three tissue pieces sewn together, DurAVR is a single 3D valve model inserted into the patient.

The third technology is a catheter that is balloon expandable.

Mr Paterson also announced that the company should soon have a Food and Drug Administration (FDA) study approved regarding its DurAVR technology. He also claimed competitor valves could not go more than 150 million cycles while DurAVR had been recorded lasting as long as 700 million cycles. One cycle is the equivalent to one human heartbeat. 200 million cycles (the equivalent of 5 years inside the body) are required for a valve replacement to obtain FDA approval.

Anteris share price history

The Anteris share price has a volatile history, regularly going through periods of peaks and troughs.

In 2004 the share price was over $200 and as recently as 2016 was at or near $100. Anteris shares have been in long-term decline since. However, the share price has rallied over the past week and has been on a small upward trajectory from the beginning of 2021.

The post Why the Anteris Technologies (ASX:AVR) share price soared 23% today appeared first on The Motley Fool Australia.

Let's take a look and see how the structural heart company performed for the period.

FY20 performance

The Anteris share price could be under pressure today after the company reported a disappointing end to its FY20 performance.

According to yesterday's late market release, Anteris advised it achieved a significant drop off across its key metrics.

For the period ending 31 December, total revenue fell to $7.1 million, a decline of 58% over the prior corresponding period. Most of the revenue generated came from the manufacturing of its CardioCel and VascuCel patches under the LeMaitre Vascular Inc. agreement. In addition, the company began winding down operations in the Infusion segment. COVID-19 had a minimal impact on Anteris due to the early implementation of its risk-management strategies.

Other income for the company totalled $4.8 million, which included $2.2 million in licencing income from 4C Medical Technologies. This was in relation to the transfer of the sterilisation method for use with Anteris' ADAPT tissue technology. The other monies consisted of research and development tax incentives and COVID-19 stimulus packages.

Investors will be eyeing off the Anteris share price in morning trade after the company reported earnings before interest, tax, depreciation and amortisation (EBITDA) sank to a loss of $13.7 million. This is in comparison to the EBITDA loss of $4.1 million recorded in the prior FY19 period.

Selling, general and administrative expenses stood at $22.1 million, an improvement from the $34.5 million in FY19. Initiated by management, cost-saving measures were attributed to lower employee, travel and conference costs. In addition, the prior period impairment of Admedus Vaccines, and favourable currency exchange movements helped support cost control.

Overall, the business recorded a net loss of $15.3 million, mostly due to investment in its 3D single-piece aortic DurAVR valve.

Anteris revealed a cash balance of $4.4 million for the end of December. It's worth noting that the company entered into a short-term facility for $1.2 million at an interest rate of 1.15% per month. The loan will be secured against the research and development refund.

The board declared that no dividend will be paid to shareholders.

About the Anteris share price

The Anteris share price is down over 30% since this time last year. Anteris shares reached a 52-week high of $9.18 in April, before plummeting down to a low of $3.01 in August.

Based on the current share price, Anteris has a market capitalisation of close to $33 million.

The post Why the Anteris (ASX:AVR) share price will be on watch today appeared first on The Motley Fool Australia.

Regardless of this lacklustre performance, these 2 ASX healthcare shares are having a pretty good day. 

Anteris Technologies Ltd (ASX: AVR)

The Anteris share price has surged 18.60% today to reach $5.10 per share. This gain comes after a tough year, with the Anteris share price dropping more than 62% over the past 12 months.

The company's mission is to create the world's most durable heart valve. While no significant news hit the wires today, the company continues to steadily progress its heart valve technology.

In March 2020, Anteris announced the first implantation of its ADAPT-treated single-piece 3D aortic valve in a patient with aortic stenosis.

At the start of this year, the company confirmed that it had entered into a short-term facility for a $1,220,000 advance, based on its forecasted research & development (R&D) tax incentive. Anteris followed this statement up two days later announcing an additional $20 million in secured funding.

According to Anteris, the company continues to focus on delivering "next generation technologies that help healthcare professionals create life-changing outcomes for patients."

CleanSpace Holdings Ltd (ASX: CSX)

The CleanSpace Holdings share price is currently up by 7.29%, trading at $7.51 at the time of writing. The company engages in the design and manufacturing of respiratory protection equipment (RPE) for healthcare and industrial employers internationally.

The purpose of RPE is to protect people from inhaling hazardous substances in the air. The Sydney-based company was founded by a team of biomedical engineers in 2009. Products sold by CleanSpace include the CleanSpace Halo for the healthcare market and the CleanSpace2, CleanSpace Ultra and CleanSpace Ex designed for industrial markets. 

While it's been a rocky ride over the previous 12-month period, the CleanSpace share price has just managed to inch into the green, returning 0.67% over the past year.

In its most recent trading update, CleanSpace upgraded its first half FY21 revenue expectations to be in the range of $39 million–$41 million for the six months ended 31 December 2020.

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During early morning trade, shares in the structural heart company pushed as high as $3.84 but have since retreated. At the time of writing, the Anteris share price is swapping hands for $3.75, up 2.46%.

Let's take a look at what Anteris does and what were the clinical results.

What does Anteris do?

Anteris, formerly known as Admedus Ltd, is a medical company that focuses on designing and manufacturing heart valves. Its next-generation technology re-engineers xenograft tissue into pure collagen scaffold, helping surgeons replace valves for patients during surgery.

Positive interim results

Anteris advised that it received positive results in its anti-clarification study using its Adapt technology.

The four-month interim report showed superior attributes for anti-clarification compared to other tissues used in competitor valves. The treated tissue used in the DurAVR 3D single-piece aortic value exhibited a 40% less calcium concentration. This was measured against the Medtronic AOA arm, tissue used in commercially available surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) valves.

In the study, 48 juvenile rats were implanted with four different samples underneath the skin for evaluation. The company stated that the concluded results correlated with existing clinical data. Head-to-head trials displayed significant differences between Adapt tissue and Edwards Life Sciences' Thermafix tissue at the eight to 12-month mark.

Anteris noted that clarification (hardening) is a major contributor to the failure of heart valve replacements made from animal tissue.

The final results at the end of the 8-month study will be submitted to the United States Food and Drug Administration (FDA). The company hopes to demonstrate that its DuARV product is better than the currently available valves in the market.

What did management say?

Anteris CEO Wayne Paterson commented on the findings and pathway for commercialisation. He said:

The results were highly positive for ADAPT, indicating our ADAPT anti-calcification treatment is statistically superior to both of the major competitors.

Whilst we have long understood the clinical superiority of ADAPT, it's critical for the regulatory submission to prove this against market incumbents specifically in the TAVR space.

About the Anteris share price

The company went through a name change earlier this year as a part of its restructuring program. Since completion of the shuffle, the Anteris share has not been a strong performer, falling more than 50% from May.

Shares in the med tech business have been mostly stagnant the past couple of months hovering around the $4 mark.

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According to its prospectus, "Invex is a biopharmaceutical company focused on the development of efficacious treatments for neurological conditions derived from or involving raised intracranial pressure, such as Idiopathic Intracranial Hypertension (IIH), acute stroke and traumatic brain injury." 

The company has taken the intellectual property of Dr Alexandra J Sinclair from the UK's University of Birmingham, with Dr Sinclair being appointed the chief scientific officer of Invex as it now attempts to commercialise its potential treatments for intracranial or 'within the skull' pressures. 

The company has no revenue, so it's basically another speculative ASX-listed biotech business now worth $42.5 million based on 50 million shares on issue, with $12 million raised to go towards funding its "later stage research and development program".

A cynic might suggest you'd need as much cash to burn as Andrew Forrest to justify investing in this kind of business, with Mr Forrest also an early backer of ASX biotech and capital sinkhole Admedus Ltd (ASX: AHZ).

That's not to say Invex can't go onto be a big success, it's just hat it has a very long road ahead of it and unless you're a medical expert on intracranial pressure treatments it's difficult to know its chances. 

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For the quarter ending December 31 2018 Admedus reported revenues of $6.4 million, but operating costs around $11 million to lead to an operating cash loss of $5.8 million.

Of the costs $6.3 million went on staff costs and $2.5 million on "corporate and administrative" over the quarter.

Worse news is that the group is forecasting cash outflows of $15.5 million in the current quarter which look unlikely to be offset by much more than the $6.4 million it earned in the current quarter.

Of the $6.4 million in last quarter's sales, $3 million came from its ADAPT business and $3.5 million from its Infusion division.

The group now has cash on hand of just $12.036 million despite conducting multiple capital raisings from long suffering retail speculators over the last 5 years.

It also looks likely Admedus will have to raise more money or take on debt within about a year if its current cash burn trajectory continues in a gloomy sign for anyone continuing to hold shares.

The company even managed to raise $19 million over the recent quarter from "investors" who will likely be feeling underwhelmed by today's update on cash flows.

It's hard to find anything positive to say about this business given its track record and large costs have returned huge losses to unsophisticated retail investors seemingly buying into its story oblivious to the reality of the cash flows.

I've warned repeatedly over the past 4 years about the danger of large losses to shareholders in this business and I don't expect that status quo to really change unfortunately.

The stock is down 95% or more in 4 years and Admedus is not alone in blowing up shareholder capital at the speculative end of the market, with others like Yojee Ltd (ASX: YOJ) and ResApp Health (ASX: RAP) also letting down a lot of less-sophisticated retail investors.

Serious investors avoid speculative capital sinkholes in favour of companies making profits and paying rising dividends, as that's how you create real wealth for you and your family….

The post Why the Admedus share price is sinking again on more big losses appeared first on The Motley Fool Australia.

However, in some good news for shareholders it's been revealed that yesterday a Starpharma director and insider, Robert Thomas, bought 50,000 shares for $47,000 on market at 96 cents per share.

This suggests Mr. Thomas at least has faith the biotech will eventually get its VivaGel BV product approved in the U.S., although the pathway ahead now is unclear as Starpharma has admitted the FDA requires "more clinical data" prior to approval.

It appears investors are taking a sell first, ask questions later approach though as management's credibility has been hurt by the FDA rejection as many in the market believed Starpharma had the clinical data already to secure approval.

The uncertainty over the situation now is likely to keep a lid in the share price until management provides a further update or proper roadmap to approval.

Starpharma does have plenty of potential on paper at least via its drug delivery technology and products already in market and is well funded with $49.5 million cash on hand. However, whether it can translate this potential into profits remains to be seen as investors are largely reliant on the worth of management's guidance on the science as to the company's potential.

For example many biotechs in the research and development space often just end up destroying investor capital such as Admedus Ltd (ASX: AHZ), Prana Biotechnolgy Ltd (ASX: PBT), Mesoblast limited (ASX: MSB) and Acrux Limited (ASX: ACR).

In fact as far as I can remember Sirtex Medical is the only start-up type biotech or healthcare business to list and go on to become a roaring success by posting big profits for investors. So there can be exceptions to the rule, but they are unusual.

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In summary the healthcare researcher presented some of the trial results for its BIT225 drug to an HIV treatment research conference in Miami, Florida.

According to Biotron the data from the trial shows that "Bit225 is having a unique effect in patients, over and above viral suppression seen with current antiretroviral drugs…..The data shows that there are significant immunological benefits in patients receiving antiretroviral drugs with 200 mg BIT225 compared to antiretroviral drugs plus placebo".

This data sounds exciting, which makes the share price fall today curious, although it should be noted that the data was already public knowledge and in the market beforehand.

The data is also only from a Phase 2 trial, with biotechnology companies normally having to complete three different trial phases successfully before they can apply to a healthcare regulator such as the US Food and Drug Administration (FDA) to have their treatment or therapy approved for commercial sale.

A phase 2 trial is generally limited in its scope in terms of patient numbers, researchers involved, etc, to save on costs as clinical trials can be very expensive and often end in failure.

However, it now seems that Biotron Limited may be able to press ahead with a large scale Phase 3 trial for the BIT225 drug.

One major problem is funding, and Biotron is openly seeking a funding partner to "support future clinical trial evaluations to further characterise a clinical impact on viral eradication".

Unfortunately as at September 30, 2018 the company had just $896,000 cash in hand on its balance sheet, no revenues and a cash outflow of $606,000 for the quarter.

However on October 17 it reported it has raised $4.7 million via an options underwriting agreement with CPS Capital Group. It did concede though that it will still need a commercial partner to further fund more clinical trials.

The stock has risen from just 2 cents prior to the original September 28 announcement about the positive data from the Phase 2 trial.

Given its financial position and early stage status it looks a high-risk bet as biotech investing is speculative by nature. Others that have struggled to deliver positive returns for investors include Admedus Ltd (ASX: AHZ) and Mesoblast limited (ASX: MSB).

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