That's the view of analysts at Bell Potter, who believe this small-cap ASX share could deliver market-beating returns over the next 12 months.

What is Cyclopharm?

It is a medical device company operating in nuclear medicine.

Bell Potter notes that Cyclopharm's main revenue driver is Technegas, which is a system indicated for functional lung imaging.

The primary use of Technegas is diagnosis of pulmonary embolism in patients contraindicated for a CT scan. It was approved for use in the United States in September 2023.

Bell Potter was pleased with the small-cap ASX share's annual general meeting update. It points out that management remains bullish on the remainder of 2026 and beyond. It said:

The AGM commentary maintains the bullish outlook for the remainder of CY26 and beyond. The CEO re-affirmed guidance for 250 – 300 Technegas generators installed in the US by the end of 31 Dec 2026. There are currently 55 generators in market, hence 195 instals required to meet the bottom end of guidance. We estimate 11 instals in the first 17 weeks of CY26 including 5 since 31 March.

Bell Potter also highlights that the small-cap ASX share has a sizeable pipeline with a high conversion probability. The broker adds:

CYC has 175 contracts signed and awaiting installation with a further 111 at contract review stage and described as a very high conversion probability. Beyond these, the pipeline is extensive with several hundred devices at the proposal stage. Numerous hospital groups have now committed to subsequent devices across locations in their networks, in fact, half the growth (we presume in FY26) is attributable to 2nd and subsequent orders by existing clients. We conclude that the signs are highly encouraging for strong revenue growth in FY26.

~9 weeks remain in the half, hence CYC is on track to hit our forecast of 65 instals in the US by 30 June. The bottom end of the guidance requires an enormous acceleration of installations in 2H, however, with contracts in place the business is there to be had. The client service teams are now engaged with multiple installation programs at any one time to ensure a continuous stream of instals on a weekly basis.

Small-cap ASX share tipped to rise

According to the note, the broker has retained its buy rating and $1.00 price target on Cyclopharm's shares.

Based on its current share price of 84.5 cents, this implies potential upside of 18% for investors over the next 12 months.

Commenting on its buy recommendation, the broker said:

The revenue base to CYC from 250 devices in the US is estimated at ~A$23m annual recurring revenue. We expect cash burn has now peaked and will begin to fall in 2H26. Next major catalyst is the June quarter update where we are increasingly confident that the pace of generator installations in the US will be sustained at the current rate or better. No earnings adjustments, PT remains $1.00.

The post Which small-cap ASX share could beat the market over the next 12 months? appeared first on The Motley Fool Australia.

One such ASX small-cap that Bell Potter believes is worth keeping an eye on is Cyclopharm Ltd (ASX: CYC). 

Company overview

Cyclopharm is a medical device company operating in the specialist field of nuclear medicine. 

The main revenue driver is Technegas – a system indicated for functional lung imaging. 

The primary use of Technegas is diagnosis of pulmonary embolism in patients contra indicated for a CT scan. The product was approved for use in the United States in September 2023.

Investing in small-cap healthcare stocks like Cyclopharm is a high risk, high reward play. 

These types of companies often sit on a single product or technology that, if successfully commercialised or approved in a major market, can scale rapidly and generate outsized returns. 

Key catalysts to monitor are regulatory approvals or clinical results. These can sharply re-rate valuations.

In Cyclopharm's case, the appeal lies in having an already commercialised product with recurring revenue potential and a major growth runway in the US. 

The bear case, however, is just as important. 

Small-cap healthcare is inherently risky due to heavy reliance on one product, execution challenges in new markets, regulatory uncertainty, and the constant need for capital, which can dilute shareholders. 

This volatility has been on full display this year for Cyclopharm shares, as it has fallen 26% year to date. 

Bell Potter's view

In a new report from Bell Potter, it seems the broker is leaning more towards the bull case. 

The broker said the pace of deployment for Technegas generators in the US has begun to increase.

Cyclopharm Ltd installed six new devices in the first quarter of 2026, with at least 15 more expected by 30 June 2026. 

It previously took 21 months to reach 50 devices after pricing changes began in July 2024. However, the next 50 installations are expected to be completed much faster, within six to eight months from April 2026. 

Total installations are forecast to reach around 65 devices by the end of June.

Growth expected to lift

Bell Potter also noted a February 2026 capital raise at $0.95 per share increased cash to roughly $20 million. 

Cash burn in the second half of 2025 was $9.8 million and is expected to have peaked. Additionally, growth in the US is projected to lift gross margins toward 80%, up from around 55%.

We anticipate the company reaches breakeven at ~310 installed Technegas systems in the US, generating A$19m in revenues.

Elsewhere, Technegas has been explicitly recognised in draft guidelines issued by the two leading professional bodies in the US for nuclear medicine for ventilation perfusion and specifically for the assessment of pulmonary embolism This a significant item – recognition in guidelines for US healthcare providers is compliance matter which hospital operators take extremely seriously.

Strong upside for this ASX small-cap

Bell Potter has retained its buy recommendation for Cyclopharm shares. 

However the broker has reduced its price target to $1.00 (previously $1.50) following earnings downgrades and dilution from the recent capital raise. 

From yesterday's closing price of $0.725, this indicates an upside potential of 38%. 

The post Down 26% year to date, is it time to buy low on this ASX small-cap? appeared first on The Motley Fool Australia.

That's because compared to other sectors like financials (big banks) and resources (mining and energy), healthcare makes up a much smaller portion of the ASX's total market capitalisation.

For example, financials and materials can account for 50–60% of the ASX 200, while healthcare often contributes around 10–12%, depending on market conditions.

Furthermore, the healthcare sector on the ASX is dominated by a few major companies:

• CSL Ltd (ASX: CSL) – one of Australia's largest companies, and by far the biggest healthcare stock.
• Cochlear Ltd (ASX: COH), ResMed Inc (ASX: RMD), and Sigma Healthcare Ltd (ASX: SIG) are also prominent.

This means the sector's performance is heavily tied to these few holdings, making it less diversified than in other markets like the US.

However, that also means there are hundreds of growth stocks with the potential to bring large returns. 

Let's look at two that are tipped for growth according to broker Bell Potter. 

Clinuvel Pharmaceuticals Ltd (ASX: CUV)

This biopharmaceutical company develops and commercialises treatments for rare genetic and skin disorders, especially those related to light sensitivity.

This healthcare stock has seen its share price fall 34.53% over the last year. 

However, Bell Potter sees opportunity in this healthcare stock. 

The broker maintains its "buy" recommendation and $21.45. 

At the time of writing, shares are trading at $9.99 each, which indicates an upside of approximately 117.7%. 

The company is optimistic thanks to the company's lean, vertically integrated business model. 

Furthermore, the broker noted that the company commercialises Scenesse, the only approved drug in the US and EU for patients with EPP (Erythropoietic protoporphyria). 

Cyclopharm Ltd (ASX: CYC)

Cyclopharm Ltd. is a radiopharmaceutical company, which engages in diagnostic imaging in lung health. It manufactures and sells medical devices and pharmaceutical products.

At the time of writing, CYC shares are down 42.86% in the past year. 

This significant drop might mean it's been oversold, with Bell Potter placing a "buy" recommendation and $2.20 price target. 

This indicates a 134.0% upside from its current price of $0.94. 

A report from the broker last month highlighted the company has experienced slower than expected growth. 

However, the underlying U.S. market opportunity remains significant according to Bell Potter. 

Investors should be also aware that growth stocks can come with increased upside, but simultaneously more volatility.

The post These healthcare stocks could be set to double according to broker appeared first on The Motley Fool Australia.

At market close yesterday, these three companies were leading the charge higher in the nascent new year.

You'll also notice a decided trend in the sector they operate in.

Which soaring ASX All Ords shares are we talking about?

Read on!

ASX All Ords shares setting the bar high for 2025

The third-best performing stock on our list (bumped from second place at Thursday's close) is Imugene Ltd (ASX: IMU).

Shares in the ASX All Ords healthcare stock closed out 2024 trading for 3.7 cents. In afternoon trade on Friday, shares are changing hands for 4.3 cents apiece, up 16.2% in 2025.

Imugene attracted significant investor interest after the company released an update on a clinical trial last Friday. Shares leapt 12.8% on Monday.

Imugene reported that the first Australian patient had been dosed in the Phase 1b clinical trial at the Royal Prince Alfred Hospital (RPAH) in Sydney.

As the Motley Fool reported on the day:

This trial is focused on patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), which is one of the most challenging and aggressive forms of non-Hodgkin's lymphoma.

"Achieving first patient dosed for azer-cel in Australia represents a significant milestone for Imugene and for Australian patients battling this devastating disease," Imugene CEO Leslie Chong said.

This brings us to the second-best-performing ASX All Ords share of 2025 (moving up from number three at Thursday's close): Cyclopharm Ltd (ASX: CYC).

Shares in the healthcare stock closed on 31 December trading for $1.585. At the time of writing today, shares are swapping hands for $1.985 apiece, up 25.2% year to date.

The last price-sensitive news released by Cyclopharm was back on 20 December.

In a response to an ASX price query on the rapid gains posted, the ASX All Ords company said it was not "aware of any information concerning it that has not been announced to the market which, if known by some in the market, could explain the recent trading in its securities".

Cyclopharm added that it was "carrying on business in the ordinary course in accordance with its disclosed strategic direction and commercialisation plan".

At the head of the pack in 2025

At the head of the pack in these early days of 2025 is Silicon Valley-based EBR Systems Inc (ASX: EBR), which is focused on treating cardiac rhythm disease. (Did you pick up the sector trend yet?)

The EBR Systems share price closed out 2024 at $1.025. In Friday afternoon trade, shares are changing hands for $1.40 apiece. That sees this ASX All Ords stock up 36.6% already in the new year.

On Monday, the company, which is developing the world's only wireless cardiac pacing device for heart failure (WiSE), reported that the US Food and Drug Administration (FDA) had scheduled the manufacturing Pre-Approval Inspection (PAI) to commence on 14 January.

"This significant milestone brings us even closer to US commercialisation and to making available our life-changing WiSE technology to heart failure patients in need," EBR Systems CEO John McCutcheon said.

The post 3 ASX All Ords shares leading the charge in 2025 appeared first on The Motley Fool Australia.

For example, the two ASX healthcare shares listed below are up at least 16% in morning trade thanks to big news in the United States.

Here's what you need to know about them:

Cyclopharm Ltd (ASX: CYC)

The Cyclopharm share price is up 18% to $1.80. Investors have been buying the ASX healthcare share this morning after it announced an interim agreement to supply the Veterans Health Administration (VA) with the pharmaceutical and consumable components of Technegas.

Technegas is the company's core radiopharmaceutical product, used in functional lung ventilation imaging.

This could be a very big deal for Cyclopharm given that the VA is the largest integrated US Government health care system in the United States.

According to the release, the interim agreement immediately provides the 120 Veterans Affairs hospitals, which have nuclear medicine departments, access to an agreed contract for these products.

Cyclopharm's CEO, James McBrayer, commented:

Securing this Interim Agreement is critical for streamlining the United States Federal Government procurement process. This agreement bypasses the need for Cyclopharm to negotiate separate contracts with each of the 20 Regional Procurement Offices within the VA or potentially follow a reseller pathway that would delay the deployment of Technegas, distance us from our customers and impact margins beyond the legislated discounts required for federal contracts.

Lumos Diagnostics Holdings Ltd (ASX: LDX)

The Lumos Diagnostics share price is up 16% to 4.3 cents.

This has been driven by news that the point-of-care diagnostic technology provider has been awarded ~US$3 million from the Biomedical Advanced Research and Development Authority (BARDA). It is part of the U.S. Department of Health and Human Services' Administration for Strategic Preparedness and Response.

These funds are to support the planned Clinical Laboratory Improvement Amendments (CLIA)-waiver clinical study and regulatory submission for Lumos' FebriDx bacterial/non-bacterial test.

FebriDx can aid clinicians with appropriate antibiotic use decisions and will hopefully improve antibiotic stewardship.

The ASX healthcare share's CEO and managing director, Doug Ward, commented,

Since early clinical practice, doctors have relied primarily on clinical observation to determine whether patients require antibiotics for acute respiratory conditions. FebriDx is a powerful diagnostic which can provide a quick and clear clinical evaluation, and in doing so, can reduce over-prescription of antibiotics.

Special mention goes to fellow ASX healthcare share Mesoblast Ltd (ASX: MSB), which is rising over 9% today. However, with no news out of the company, it remains unclear why investors are scrambling to buy its shares today.

The post 2 ASX healthcare shares rocketing over 16% on Big US news appeared first on The Motley Fool Australia.

They have just been tipped as Bell Potter's top healthcare stocks to buy now:

Aroa Biosurgery Ltd (ASX: ARX)

Aroa Biosurgery describes itself as a soft-tissue regeneration company committed to unlocking regenerative healing for everybody.

Bell Potter is feeling very positive about the company's outlook and has put a buy rating and 90 cents price target on its shares. It is expecting the ASX healthcare stock's strong top line growth to continue in FY 2025 and FY 2026. It said:

In FY24 revenues grew by 75% to NZ$23.3m and we expect a similar growth rate in FY25 and FY26 driven by an expanded user base and data from the Myriad Augmented Soft Tissue Regeneration Registry (MASTRR). ARX also expects to report data from its 120 patient randomised clinical trial in diabetic foot ulcer patients. The trial is investigating the healing properties of the Symphony product. Earlier studies in a very difficult patient population with advanced DFU's provided highly supportive data on the rate of wound healing.

Cyclopharm Ltd (ASX: CYC)

Bell Potter is also bullish on this global radiopharmaceutical company which has a focus on pulmonary care. Especially given its strong balance sheet following a recent capital raising.

The broker currently has a buy rating and $3.40 price target on the ASX healthcare stock. It said:

Cyclopharm recently completed a $24m capital raise with funds to provide working capital to support the expanding revenue base in the US. Since receiving FDA approval for Technegas in the US in September 2023, CYC has notched up numerous firsts including contract signings and first revenues earned. […] The company estimates the US market for Technegas at US$180m annually inclusive of US$90m being the initial market for diagnosis of pulmonary embolism (PE) which it believes it can win within 5 to 7 years from launch. The second stage of the market also relates to PE where the company believes it can win market share in those patients currently diagnosed via CT.

Telix Pharmaceuticals Ltd (ASX: TLX)

Finally, another radiopharmaceutical company that could be a buy according to Bell Potter is Telix. It has a buy rating and $19.00 price target on its shares.

Bell Potter likes the company due to its revenue-generating Illuccix product, as well as its promising product pipeline. The broker explains:

The fundamental drivers of value remain firmly in place, including: revenues from the sale of Illuccix continue to grow; recently completed submission of the Biological license application for Zircaix in early June; and additional catalysts including submission of the New Drug Application for Pixclara, commencement of enrolment in the prostate cancer therapy and initial data from the STARLITE trial.

The post Bell Potter names the best ASX healthcare stocks to buy in FY25 appeared first on The Motley Fool Australia.

On the property front, CoreLogic says that after a strong rebound in 2023, the Australian market will be more subdued overall next year.

The Sydney and Melbourne property markets are now slowing down. Conversely, Perth, Brisbane and Adelaide are still rocketing, according to the latest data.

In the meantime, various brokers and share market analysts have released their tips for hot ASX stocks next year.

So, where are the opportunities for investment in shares vs. property in 2024?

Where are the opportunities in property?

Investors define 'opportunities' in many different ways.

For the purposes of this article, we'll define opportunities in property as markets where prices are likely to fall, or where conditions are likely to favour buyers, in 2024.

Based on this, the experts say Sydney, Melbourne, Canberra, and Hobart may be worth considering.

CoreLogic's Head of Research, Tim Lawless, says market conditions in these cities are "now in favour of buyers". This is due to a higher supply of homes for sale compared to the other capitals.

He said advertised stock levels are currently trending above five-year averages, explaining:

In these cities, market conditions are now in favour of buyers as higher stock levels provide more choice, less urgency and greater opportunities to negotiate.

The same can't be said for Perth, Brisbane and Adelaide, where advertised stock levels remain remarkably low. Perth listings are nearly -40% below their five-year average for this time of the year, while listings are more than -30% below average in Brisbane and Adelaide.

Unsurprisingly, these cities are continuing to show a consistently high rate of growth amid strong selling conditions.

Louis Christopher of SQM Research also identifies these cities as likely to be the weakest markets of 2024, and therefore favouring buyers.

He adds Darwin to the list and anticipates price falls in all five cities in his base case predictions.

Christopher forecasts -4% to 0% movement for Sydney home values and -3% to +1% movement for Melbourne and Darwin. He attributes the softer anticipated growth in the two biggest capitals to high interest rates and rising unemployment.

Christopher is also tipping a fall in Canberra home values of between -8% and -4% in 2024. This is due to reduced Federal Government spending and rising supply due to many new apartment completions.

Where are the opportunities in ASX shares?

Top broker Morgan Stanley likes the look of ASX mining shares in 2024. It says commodity prices should remain strong, and the weaker dollar will be helpful, too.

The most important commodity of all for Australia — iron ore — has surged beyond US$140 per tonne in recent weeks. It is up from about US$117 in January.

Meantime, the Australian dollar is fetching 68.59 US cents today. This is largely in line with where it started the year.

The currency dropped to a 12-month low of about 63 US cents in October. It hit a high of about 71 US cents in February.

In light of all this, Morgan Stanley's model portfolio has bigger positions in BHP Group Ltd (ASX: BHP) and Rio Tinto Ltd (ASX: RIO).

Bell Potter is also positive on mining stocks and companies providing mining services. Among its 2024 picks are Mineral Resources Ltd (ASX: MIN), Regis Resources Ltd (ASX: RRL) and Santana Minerals Ltd (ASX: SMI).

In a recent note, analysts David Coates and Bradley Watson explained:

Looking to CY24, we are optimistic about the outlook for gold and copper in particular.

With rate cuts expected through CY24, supportive geopolitical factors and the prospect of real interest rates and the US dollar coming off multi-year highs, gold and gold equities look like attractive exposures into CY24.

The outlook is also very positive for ASX uranium shares due to a surging commodity price.

Uranium breached the US$90 per pound mark this week and is up by almost 90% over the past 12 months.

Tribeca fund manager Guy Keller describes uranium as a "new lithium", driven by Chinese demand.

In a recent Australian Financial Review (AFR) article, Keller explained:

China wants to go from 30 million pounds a year of consumption to 150 million in just 15 years.

When China makes a structural change to embrace a raw material it's short of domestically, it creates a multi-decade demand for that raw material.

Bell Potter also likes tech shares for 2024 and rates Life360 Inc (ASX: 360) and Task Group Holdings Ltd (ASX: TSK) as buys.

Analysts Chris Savage and Michael Ardrey explain:

We have a positive or constructive view on the outlook for the tech sector given the consistent increases in interest rates both domestically and internationally over the last 18 months now appear to be nearing or at an end.

We note there has been a strong rally in tech stocks in the US over the past couple of months – the NASDAQ is now around a two year high – but there has not been anywhere near as strong a rally in Australia.

We therefore believe a rally in tech stocks domestically is overdue and, if and when it comes, is likely to be led by large caps with the mid and small caps to eventually follow.

Analyst John Hester also reckons there are buy-the-dip opportunities in the healthcare sector, saying:

With many companies currently trading at depressed valuations, there are stock picking opportunities for those with solid balance sheets to ride out the cyclical downturn and clear catalysts to drive momentum.

Bell Potter's healthcare picks include Telix Pharmaceuticals Ltd (ASX: TLX) and Cyclopharm Ltd (ASX: CYC).

Shares vs. property: How do you decide?

Diversification is a key theme for all investors, and helpfully, it kinda nullifies the shares vs. property debate. With enough time on your side and reasonable financial means, you'll be able to do both.

To help you with the decision, check out our article comparing property rental returns vs. shares dividends.

You might also like to review the 10-year returns of each asset class.

If buying and owning real property investments sounds too hard, you can always invest in bricks and mortar by purchasing ASX property stocks and A-REITs instead — here's how. mid-cap healthcare stocks. However, those that achieved material commercial milestones have generated positive shareholder returns in the last six months (NEU, DXB, 4DX and PME). With many companies currently trading at depressed valuations, there are stock picking opportunities for those with solid balance sheets to ride out the cyclical downturn and clear catalysts to drive momentum.The new class of GLP-1/GIP drugs continue to dominate news flow for their impact on weight loss and other health outcomes (e.g. lowering cardiovascular events). There is little doubt these drugs will form one of the biggest selling classes to date, with both Novo Nordisk and Eli Lilly unable to keep up with demand. ASX large-cap healthcare companies, including RMD and CSL were sold off as investors drew read throughs for what these drugs could mean for long term demand growth. Fortunately there were no adverse impacts on companies in our coverage and data suggests the sell off in large cap stocks has been overdone in any case

The post ASX shares vs. property: The opportunities in 2024 appeared first on The Motley Fool Australia.

Four ASX shares that are not letting that hold them back are listed below. Here's why they are rising:

CSL Limited (ASX: CSL)

The CSL share price is up over 1% to $249.50. Investors have been buying this biotherapeutics giant's shares following the release of a bullish broker note out of Morgan Stanley. It believes that recent selling has been an overreaction and created a buying opportunity for investors. The broker has an overweight rating and a $334.00 price target on its shares.

Cyclopharm Ltd (ASX: CYC)

The Cyclopharm share price is up 2.5% to $2.94. This medical device company's shares have been on fire this week after the US FDA approved its Technegas product for the diagnosis and management of Pulmonary Embolism in the US market. The approval opens up the single largest market for Technegas globally, and one which the company estimates to be initially worth approximately US$180 million annually.

Dicker Data Ltd (ASX: DDR)

The Dicker Data share price is up almost 2% to $9.75. This appears to have been driven by another broker note out of Morgan Stanley. This morning, the broker retained its overweight rating on the IT distributor's shares with an improved price target of $11.

Fletcher Building Ltd (ASX: FBU)

The Fletcher Building share price is up almost 1.5% to $4.43. This morning, the building products company revealed that it has been assigned an investment grade credit rating from Moody's Investors Service of Baa2 with stable outlook. The company's CFO, Bevan McKenzie, commented: "Obtaining an investment grade credit rating is an important step in respect of our long-term funding strategy which will allow us to further diversify our funding sources."

The post Why CSL, Cyclopharm, Dicker Data, and Fletcher Building shares are pushing higher appeared first on The Motley Fool Australia.

That helped the All Ords post a gain of 1.2% for the first week of trading in 2023.

Investors will certainly welcome this start to the new year after All Ordinaries shares dropped 7.2% in 2022. Though it may be too early to hope for a return to 2021 levels, when the index gained 13.6% over the calendar year.

While the 1.2% gains represent a solid start to 2023, these three All Ordinaries shares delivered far more in the first week.

As you'll note below, all three of the top performers this past week suffered heavy losses in 2022. With them now leading the charge in the new year, investors look to be doing some bargain hunting.

Top 3 All Ordinaries share gainers this week

The third-best performer in the first week of trade was gold miner Alkane Resources Ltd (ASX: ALK).

Alkane has a market cap of $383 million.

Like the other top-performing All Ordinaries shares covered in this article, the Alkane share price fell heavily in 2022, down 41%.

Unlike the other two stocks, Alkane did release positive price-sensitive news this week. The Alkane share price closed up 11% on Thursday after the company upgraded its FY2023 production guidance at its Tomingley Gold Operations in New South Wales.

This helped Alkane deliver a 24% gain in the first week of trading in 2023, finishing the week at 67 cents per share.

The number two spot goes to diagnostic imaging company Cyclopharm Ltd (ASX: CYC).

Cyclopharm has a market cap of $125 million.

The All Ordinaries healthcare share tumbled 29% in 2022 but is certainly off to a better start this year. Cyclopharm closed the week up 25% at $1.46 per share.

Which bring us to the best All Ordinaries share performer in the first week of 2023, financial services company Harmoney Corp Ltd (ASX: HMY).

Harmoney has a market cap of $58.4 million.

The stock lost a painful 76% in 2022 but staged a strong rally to kick off 2023, gaining 30% in the first week of trade. Harmoney closed the week trading for 57 cents per share.

The post Can you guess the top 3 performing All Ordinaries shares in the first week of trade? appeared first on The Motley Fool Australia.

Shares in the company were up by more than 7% in earlier trade after hitting an intraday high of $1.775.

Lets take a look at what Cyclopharm announced.  

Record first-half revenue

The Cyclopharm share price is getting a boost today after the company released unaudited accounts for the 6 months ending 30 June 2021.

The report was highlighted by record half-year revenue of approximately $8.1 million. The result reflects a 45% increase from the prior corresponding period.

In addition, Cyclopharm highlighted that revenues from Patient Administration Sets are expected to be 20% higher than the first half of 2020.

Cyclopharm noted that the revenue performance reflects the continuing shift in the mix of consumable sales to higher margin markets.

The company also highlighted that net cash at the half-year is expected to be in excess of $30 million. As a result, Cyclopharm confirmed its intention to pay a dividend of 0.5 cents per share at the half-year.

Cyclopharm managing director, James McBrayer said of the results:

Cyclopharm's strong revenue growth across all our product and service lines in our established markets is driving the business to significantly outperform the results in the first halves of 2020 and 2019.

Cyclopharm share price snapshot

Cyclopharm is a biotech company that operates in the diagnostic imaging field, specialising in lung health. The company's flagship Technegas technology is used across 60 countries throughout the world.

The Cyclopharm share price was travelling well in 2021 until last week when it tumbled around 40% following a market update.

The company announced it had received negative feedback from the United States Food and Drug Administration (FDA), sending investors running for the hills.

According to the announcement, the FDA noted that Cylopharm's Technegas could not be approved as it stands.

The FDA gave Cyclopharm a list of items it needs to address within 12 months to potentially gain approval. Cyclopharm assured the market it will be able to address the required issues and still hopes to secure FDA approval in 2022.

Despite today's bounce, the Cyclopharm share price remains more than 32% lower for the year.

The post Cyclopharm (ASX:CYC) share price jumps on trading update appeared first on The Motley Fool Australia.

Below, we take a look at the ASX healthcare company's latest market update.

What did Cyclopharm announce?

The Cyclopharm share price is crumbling after the company reported on the latest developments regarding approval of its Technegas medical imaging drug in the United States.

The radiopharmaceutical company said the United States Food and Drug Administration (FDA) had provided a Complete Response Letter (CRL) for its New Drug Application (NDA).

In that response, the FDA said it could not approve the NDA for Technegas as it stands. The agency gave Cyclopharm a list of items it needs to address within 12 months to potentially gain approval. The company stated it expects to be able to sort out the required issues and hopes to still secure approval in 2022.

Commenting on the FDA response, James McBrayer, Cyclopharm CEO said:

While the elements in the USFDA's CLR letter are attainable within the required timeframe, we are disappointed with this news of the additional technical information requests. Effectively the CLR has extended the expected approval timeframe by around nine months.

We have complete confidence that we can address these matters and do what is required to expedite this process. We now have clarity as to what will satisfy the USFDA's expectations and will commence work on the response immediately.

McBrayer said Cyclopharm is working closely with the FDA in order to address the outstanding elements still required.

The company updated its guidance for gaining FDA approval from the second half of 2021 to the second half of 2022. It said this delay will not influence its ability to fund the rest of the approval process. The US is a core part of the company's growth plans, which it estimates to be worth US$180 million (AU$237 million) per year.

Cyclopharm already sells Technegas in 60 other nations, with over 4.4 million patients using the medical imaging drug so far.

Cyclopharm share price snapshot

With today's early losses factored in, Cyclopharm shares have only gained around 19% over the past 12 months, compared to the 25% gains posted by the All Ordinaries Index (ASX: XAO).

Year to date, the Cyclopharm share price is now down by 36%.

The post Why the Cyclopharm (ASX:CYC) share price is crashing 42% lower appeared first on The Motley Fool Australia.

Cyclopharm shares are down 1% to $2.82 at the time of writing, after gaining more than 10% over the past week.

Cyclopharm Ltd is an Australia-based company that engages in the manufacture and sale of medical equipment and radiopharmaceuticals, including associated research and development.

Highlights from Cyclopharm's market update

Cyclopharm reported significant metrics in its AGM, noting record group sales revenue in 2020 of $14.7 million, up 4.2% on 2019. It recorded $2.2 million of new third‐party distribution revenue in its Technegas distribution network.

Overall, Technegas sales rebounded by 51.4% in the second half of 2020, after a pandemic-impacted first half. The company reported a $5.8 million net loss before tax. The company's February 2021 capital raising placement was oversubscribed, raising $33 million in total.

Cyclopharm AGM Chair's address

Cyclopharm Chair, David Heaney, expanded on the company's rebound from COVID-19.

2020 was a pivotal year for Cyclopharm. Despite the challenges we faced from a global coronavirus pandemic, we have expanded our global footprint to  include sales into over 60 countries, and proudly, our Technegas products have now been used in over 4.3 million patient procedures globally. We also commenced operations as a distributor of third party products in Europe, leveraging our existing distribution capabilities.

Together with our existing Technegas revenues, this new income stream enabled Cyclopharm to report record revenues in 2020 of $14.7 million. Our strong underlying sales performance supported the Board's decision to maintain our full year dividend at 1.0 cent per share.

Background on Cyclopharm's business model

Cyclopharm operates through two segments. Its Technegas segment involves supplying diagnostic equipment and consumables used by physicians in the detection of pulmonary embolism. Meanwhile, its Molecular Imaging segment produces radiopharmaceuticals to be used by physicians in the detection of cancer, neurological disorders, and cardiac disease. The company generates maximum revenue from the Technegas segment.

Cyclopharm share price snapshot

The Cyclopharm share price has had a good run recently, up 10% in the past week, 11% the past month, 14% in 2021 so far and 146% over the past 12 months. 

The post Why is the Cyclopharm (ASX:CYC) share price down today? appeared first on The Motley Fool Australia.

Cyclopharm shares went as high as 14.41% in afternoon trade before closing 6.78% up at $2.52 per share.

What Cyclopharm does

Cyclopharm is an ASX-listed radiopharmaceutical company headquartered in New South Wales. It currently has a market capitalisation of just over $203 million.

As stated on the company's website, "the company's mission is to provide nuclear medicine and other clinicians with the ability to improve patient care outcomes."

The health company aims to achieve this objective through the provision of its core radiopharmaceutical product, Technegas, which is used in functional lung ventilation imaging.

What happened?

Today, the Cyclopharm share price went soaring after the company announced an update on its progress towards gaining United States Food and Drug Administration (USFDA) approval. The company needs USFDA approval in order to begin sales of Technegas, its flagship product, in the US.

The company announced that its phase 3 trials have met their Primary and Secondary Efficacy Endpoints in September of last year. As such, it will continue its ongoing "positive" dialogue with the USFDA in order to get its approval of Technegas.

Based on these discussions, the company remains highly confident the approval process is on track to be completed in the second half of FY21.

Cyclopharm also updated its guidance for FY20 revenue. The company stated that despite the challenges of COVID-19, revenue is expected to be in line with that of FY19, which was approximately $14 million.

US market entry

With the impending approval of Technegas, Cyclopharm has begun undertaking activities to ensure it is well placed to rapidly roll out its product. These activities include building inventory reserves, finalising agreements for third party distribution, service and installation, and administrative support.

According to Cyclopharm, the existing market for nuclear medicine ventilation in the US is estimated to be roughly US$90 million annually.

Based on Cyclopharm's experience in the Canadian market, it remains confident that Technegas can achieve a 50% share of the USA market over 2 to 3 years, with an 80% share representing around 480,000 procedures per annum achievable over a 5 to 7 year period.

The post Why the Cyclopharm (ASX:CYC) share price popped 6% today appeared first on The Motley Fool Australia.

Shares in the diagnostic imaging technology developer surged 28.2% to a record high of $2.50 in the last hour of trade, taking its total gain to 78.6% in three days.

In contrast, the All Ordinaries (Index:^AORD) (ASX:XAO) and the S&P/ASX 200 Index (Index:^AXJO) have lost more than 1% each at the time of writing.

Successful trial triggers Cyclopharma share price surge

Cyclopharma announced on Tuesday that the Independent Data Monitoring Efficacy Committee (DEMC) has unanimously recommended that the company's Technegas Phase 3 trial (CYC-009) be stopped as it was a success.

This means Cyclopharma can suspend the trial. Following consultation with the US Food and Drug Administration (USFDA), the CYC‐009 study will be terminated with orderly formal site close out and notification to reviewing Investigational Review Boards.

"Given over three decades of clinical use, hundreds of clinical papers and references in practice guidelines featuring the benefits of Technegas, we were always confident of a positive outcome," said the company's chief executive James McBrayer.

"The recommendation handed down by the DEMC overnight Australian time validates our confidence in our Technegas technology and further de‐risks our pathway to USFDA approval to sell Technegas in the USA market in 2021."

Poised to join prestigious ASX club

If Cyclopharma gains final USFDA approval for its lung test, which looks likely, it will join the league of other successful ASX medical device companies.

These include the Nanosonics Ltd. (ASX: NAN) share price, RESMED/IDR UNRESTR (ASX: RMD) share price and Cochlear Limited (ASX: COH) share price.

What Cyclopharma's technology does

Cyclopharma's Technegas technology uses very fine radioactive carbon, which is inhaled by a patient. This allows detailed images to be taken by a gamma or single photon emission computed tomography (SPECT) camera.

The technology can be used to diagnose COPD, asthma, pulmonary hypertension and certain interventional applications to include lobectomies in lung cancer and lung volume reduction surgery.

Shareholders breathing easy

The CYC‐009 clinical trial is a prospective, 240‐patient, non‐inferiority comparison against Xe‐133. The Phase 3 trial design was approved under a Special Protocol Assessment granted on 4 October 2016.

The impact of COVID-19 slowed patient recruitment and only 204 patients (or 85% of the targets number) were imaged. This prompted the USFDA to call in an independent committee to review the efficacy data.

The positive recommendation from the DEMC does not guarantee that the USFDA will give CYC-009 its final tick of approval, but this is likely as federal regulators are often guided by independent panel of experts.

The post Why the Cyclopharma (ASX:CYC) share price surged to record high today appeared first on The Motley Fool Australia.

After jumping as much as 21.83% higher in early trade, Cyclopharm shares have pulled back somewhat to currently sit 9.16% higher at $1.55 per share. This takes its market capitalisation at the time of writing to around $121 million.

About Cyclopharm

Cyclopharm is a radiopharmaceutical company primarily involved in the field of nuclear medicine. It operates in the diagnostic imaging field, specialising in lung health.

The company's core radiopharmaceutical product is Technegas, a structured ultra-fine dispersion of radioactive labelled carbon used in lung ventilation imaging.

Cyclopharm has a global presence, distributing its products in 57 countries throughout the world with more than 1,500 medicine departments utilising Technegas.

Why is the Cyclopharm share price rocketing?

This morning, Cyclopharm announced that it has been granted approval to file status for its new drug application (NDA) for Technegas. 

As a result, Technegas will now proceed to the next stage of the US Food and Drug Administration (FDA) approval process – review. The review stage will involve a 10-month qualitative review where the FDA will assess "the safety and efficacy of Technegas as a nuclear medicine functional lung ventilation imaging agent"

The NDA approval announced today marks the 3rd milestone in the company's 7-step pathway to achieving FDA approval for Technegas.

Commenting on today's update, CEO James McBrayer said:

We are absolutely thrilled with the progress we are making in completing the steps to gain approval to market Technegas in the USA. This Approval to File follows our successful lodgment in March and a full USD $2.9m Fee Waiver designation in April. Today's notification confirms that we are on track for Technegas to be approved early next year.

As for Cyclopharm's total addressable market opportunity, Mr McBrayer stated:

The United States is the largest nuclear medicine market in the world. We estimate the size of the US market for Technegas in diagnosing the presence of Pulmonary Embolism (PE) is approximately US$90 million in sales per annum. Following USFDA approval to sell into that market, we will be targeting a 50% share of this market in the first 2 to 3 years, rising to 80% over 5 to 7 years.

The company also has plans to expand Technegas beyond PE into new applications, such as the diagnosis and monitoring of chronic obstructive pulmonary disease (COPD), asthma, and other respiratory diseases.

The post Cyclopharm share price rockets 22% higher on FDA application approval appeared first on The Motley Fool Australia.

Dorsavi Ltd (ASX: DVL) has a market capitalisation of $66 million. It develops technology that accurately measures human movements in elite sports, occupational health and safety, and clinical settings.

Dorsavi's solutions include both sensors and software. The company earns both upfront product revenue and ongoing recurring fees. However, the breakdown of these two separate income streams is not currently disclosed.

The business has three key markets of Australia, Europe and the USA. Australia remains the largest revenue contributor at $1.1 million for the first half of 2017, but Europe and USA are far more significant in terms of growth potential. Indeed, the USA division recorded $0.5 million of revenue in the first half of 2017, exceeding total full-year 2016 revenue for the region.

For the first half of 2017, Dorsavi grew sales revenue by 33.8% to $1.7 million and reduced losses by 59% to $1.3 million. The company is well funded with $11.7 million in cash which given current growth rates, gross margins and cash burn should be sufficient to reach profitability in my opinion.

My one concern with Dorsavi is that wearable technology is a competitive field. I wouldn't be surprised to see the likes of Fitbit or even Apple become direct competitors to Dorsavi in the future.

Mach7 Technologies Ltd (ASX: M7T) has a market capitalisation of $54.9 million and develops healthcare imaging software. It also has a small medical 3D printing business.

The company's software is installed at 529 sites in 11 countries and customer contracts typically last five years with an increasing proportion of revenue paid monthly rather than upfront. It is costly for customers to switch providers and so combined with the transition to monthly invoicing, it is reasonable to view the revenue that Mach7 earns as recurring in nature.

In February, Mach7 announced that it expects to achieve profitability at the earnings before interest, tax, depreciation and amortisation (EBITDA) level in 2017 on the back of surging revenues. Revenue for the first half of 2017 rose 40% to $4.8 million on a pro forma basis. The company's growth potential is significant as its products address a multi-billion dollar global market.

As predominantly a software company, Mach7 earns very high gross margins – 94% for the first half of 2017. Consequently, most of the revenue growth for the period converted to incremental profits. EBITDA losses fell from $3.3 million in the prior corresponding period to $1.4 million for the first half of 2017.

Clearly, significant revenue growth is required in the second half of 2017 for Mach7 to achieve a breakeven result for the year and so there is a good chance that the company will fall short. Mach7 had $5.8 million in cash at 31 December 2016 so should not need to raise any further equity assuming this goal is met.

Unlike the above two businesses, Cyclopharm Limited (ASX: CYC) is already profitable and yet has the lowest market capitalisation of the three at $47.8 million. The company's main product is Technegas, a lung imaging technology whereby the patient inhales radioactive gas.

Cyclopharm also enjoys an attractive annuity like income stream. Technegas consists of a generator and consumable Patient Administration Sets (PAS). Generator sales are one-off, high value and low margin, whereas PAS sales are recurring, low value and high margin. As the base of installed generators grows, so too does Cyclopharm's high-margin PAS recurring revenue stream.

Technegas is currently approved for use in most developed global markets outside the US for testing Pulmonary emboli (PE). PE is where arteries in the lungs become blocked by a blood clot. Cyclopharm is currently pursuing regulatory approval in the US as well for Chronic Obstructive Pulmonary Disease (COPD) which is a much bigger market than PE.

Revenue rose 14% to $14.4 million in 2016 and underlying EBITDA from the Techegas business increased 15% to $3.4 million. However, statutory EBITDA was just $1.5 million largely because the company spent $1.1 million on progressing regulatory approvals.

And this is the risk with Cyclopharm. The company could potentially waste years of profits on pursuing FDA approval with no guarantee of success. On the other hand, if Technegas is approved for the US market or for COPD, then the stock would be worth multiples of its current price.

The post 3 speculative micro-cap shares that could make you a fortune appeared first on The Motley Fool Australia.

It's difficult for the members of the ASX Top 20 Index to double, triple or quadruple revenues in a short period of time – but smaller companies can do that – if you find the right ones that is.

Here are three that investors might want to consider adding to a solid portfolio…

FSA Group Ltd (ASX: FSA)

FSA Group provides debt solutions and lending services to consumers – mainly to help consolidate debt and sort out their finances – and has a market cap of around $130 million. It's the largest provider of debt agreements in Australia, originating 48% of all agreements in Australia in 2015. Back in May, the company announced that it had sold its factoring business for around $10 million in after-tax cash. Add to that the company's cheap price – at $1.05, the company is trading on a trailing P/E ratio of 9.7x and paying a dividend yield of more than 6% – fully franked.

Joyce Corporation Ltd (ASX: JYC)

A retailer of bedding through the Bedshed franchise chain (~30 stores), Joyce Corp has a market cap of around $36 million, but had substantial cash ($13.7m) and property (~$5m) on its balance sheet. The company also owns 51% of KWB Group (Kitchen Connection and Wallspan) – a retailer and installer of custom kitchens and wardrobes – and recently announced the acquisition of 51% of Lloyds Online auctions for $6 million. Lloyds is expected to add $10 million in revenues to Joyce Corp and boost total sales across the network to more than $170 million in the 2017 financial year. (Note: Not all of that is attributable to Joyce Corp).

The company also pays a solid and growing fully franked dividend, and at the current share price of $1.32, looks reasonably cheap.

Cyclopharm Limited (ASX: CYC)

It's not often that you find a biotech stock that generates growing revenues, is profitable, debt free and also pays out dividends but Cyclopharm is one. The company's primary product is Technegas – a lung imaging technology widely used around the world to diagnose the presence of blood clots. Cyclopharm also expects to have another product coming onto the market next year – Ultralute – a product that extends the useful life of nuclear isotopes by up to 50%.

Cyclopharm has a market cap of just $72 million, but generated $4.8m in net profit in the 2015 financial year and paid a 1 cent fully franked dividend.

But the biggest catalyst could be ahead with Technegas commencing phase III trials in the US in 2012. The US has the potential to become the company's biggest global market for Technegas.

The post 3 cheap diversified micro-cap stocks for your portfolio appeared first on The Motley Fool Australia.

But that doesn't mean all stocks listed on the Australian Stock Exchange have gone nowhere. In fact, 10 companies have seen their share prices soar by more than 50%, and 4 of these have more than doubled.

Cynata Therapeutics Ltd (ASX: CYP) has leapt 228% since early February to $1.18. The stem cell research company achieved a major breakthrough, achieving commercial-scale manufacture of stem cell products. As you can well imagine, that has major implications if Cynata can go on and commercialise its technology.

AtCor Medical Holdings Limited (ASX: ACG) is up 120% to 21 cents. AtCor received Category 1 approval for its SphygmoCor blood pressure system in the US. Colleague Brendon Lau covered the news in more detail here.

Cyclopharm Limited (ASX: CYC) jumped 116.9% to 64 cents, after reporting record sales of $12 million and an record net profit of $4m – although that included a $2.65 million legal settlement. Cyclopharm is a nuclear medicine company, with products including Technegas for lung imaging. Has the company turned the corner like CEO James McBrayer thinks it has?

Cokal Ltd (ASX: CKA) has seen its shares soar 128.6% to 10 cents, despite the company being a coal explorer. In late February, Cokal received construction and operational approval for its Bumi Barito Mineral (BBM) Project port facilities in Indonesia. BBM is expected to produce a premium coking coal over a period of more than 15 years.

TNG Limited (ASX: TNG) has gained 77.8% to trade around 17 cents currently. TNG is focused on developing its flagship Mount Peak Vanadium-Titanium-Iron project near Alice Springs, which the company says can deliver revenues of $13.6 billion. Yesterday TNG signed an offtake agreement with Korean metals group WOOJIN IND. Co. for up to 60% of forecast production.

Aeris Environmental Ltd (ASX: AEI) shares have climbed 50.7% to trade around 51 cents currently. Aeris is an expert in the removal of bacteria and mould that naturally builds up in air-conditioning, cold storage and bulk water systems and then protects the asset from further recontamination. Aeris recently reported strong growth in purchase orders and potential pipeline of large scale projects.

1-Page Limited (ASX: 1PG) has jumped 66.7% to $1.65 after the company signed a number of major deals, including giant US retailer Amazon for its 1-Page sourcing and referral engine. 1-Page offers companies a new way to hire prospective employees.

Joyce Corporation Ltd (ASX: JYC) has gained 50.8% to trade at 95 cents. The company owns a chain of bedding stores under the BedShed brand. Joyce recently sold a property for $25 million, and the board is considering a suitable return to shareholders of the settlement proceeds, expected to be a franked special dividend of 5 cents per share each year for the next three years. Joyce is forecast to pay 10.5 cents in total this year.

Anatarra Lifesciences Ltd (ASX: ANR) is up 57.6% to 52 cents. Anatarra develops non-antibiotic solutions for gastrointestinal diseases in animals and humans, and recently reported a successful trial on a pig farm of its Detach product. Anatarra is now focused on registering Detach in Europe and the USA, and hopes to launch Detach in 2016 in Australia.

Last but not least is Digital CC Ltd (ASX: DCC) which is up 66.7% to 14 cents. The company is a digital payments company – the first bitcoin focused company listed on a major exchange. Bitcoin is a digital currency that is usually in the news for the wrong reasons, and there's no guarantee that Bitcoin will be successful.

The post 10 stocks up by more than 50% in the past month appeared first on The Motley Fool Australia.