{"id":6667,"date":"2024-03-04T10:33:50","date_gmt":"2024-03-04T10:33:50","guid":{"rendered":"https:\/\/economicherald.net\/?p=6667"},"modified":"2024-03-04T10:33:50","modified_gmt":"2024-03-04T10:33:50","slug":"dr-borehams-crucible-does-clinuvels-investor-value-run-deeper-than-just-makes-scenesse","status":"publish","type":"post","link":"https:\/\/economicherald.net\/?p=6667","title":{"rendered":"Dr Boreham\u2019s Crucible: Does Clinuvel\u2019s investor value run deeper than just \u2018makes Scenesse\u2019?"},"content":{"rendered":"

In a recent whimsical \u2018news communique\u2019 to investors, Clinuvel Pharmaceuticals (ASX:CUV)<\/a> chief Dr Phillipe Wolgen dwells on the \u201cthe scale of human suffering and senseless acts of violence being waged against civilians\u201d in the Ukraine and Middle East conflicts.<\/p>\n

He adds that this \u201cprompts deeper reflection on the purpose of existence. At Clinuvel, we are conscious that we live in an asymmetrical world and [are] compassionate towards the plight of those living under conditions of war.\u201d<\/p>\n

On a more temporal note, Dr Wolgen notes the less-than-rosy conditions in the healthcare sector, with a slew of US bankruptcy protection filings in 2023.<\/p>\n

\u201cAgainst this background, we are continuing our approach towards future growth and diversification. This will strengthen our position quelling market concerns about being able to operate independently,\u201d he says.<\/p>\n

Sadly, the message isn\u2019t getting through to investors, judging from the 12 per cent share sell-off after last week\u2019s half-year results. <\/p>\n

The numbers looked OK to the naked eye, given the ongoing sales traction with the company\u2019s flagship skin product Scenesse, to treat the rare skin intolerance disease erythropoietic protoporphyria (EPP). <\/p>\n

But brokers complained the company missed earnings and revenue expectations.
\n\u00a0<\/p>\n

About Clinuvel<\/h2>\n

Previously known as Epitan, the company was focused on developing a safe tanning product, before dropping the body-beautiful stuff in favour of \u2018serious\u2019 medical applications.<\/p>\n

Or has it? See below. <\/p>\n

Scenesse evolved from laboratory work by four scientists at the University of Arizona in 1987. <\/p>\n

In 1995, the owners applied for investigational new drug status with the US Food and Drug Administration (FDA), in view of a safe tanning product.<\/p>\n

The agency said \u2018nope\u2019. <\/p>\n

Epitan was incorporated in 1999 and back-door listed on the ASX in 2000, before changing its name to Clinuvel in 2006. In 2003, the FDA knocked back the drug a second time and the drug was outlicensed to an Australian team.<\/p>\n

Spurred by Swiss studies showing an 11-fold improvement in sunlight tolerability, Clinuvel honed its commercial strategy to focus on EPP.<\/p>\n

The first EPP patients were treated in Italy after the government agreed to subsidize part of the cost to users. European regulators approved the drug for adult EPP use in 2014 and the company launched the drug there in 2016. <\/p>\n

The FDA approved the drug in 2019 and it can also be sold here and in Israel. Meanwhile, the nasties at the UK National Institute of Healthcare Excellence (NICE) continue to hold out.<\/p>\n

While Scenesse is approved for adults, the company is seeking assent to treat kids between 12 and 17.<\/p>\n

In 2014, the company rejected a $2.17 a share, $95 million takeover offer from Retrophin. Sagely, the board told Retrophin to do the sun-smart thing and stick their offer where the sun don\u2019t shine.<\/p>\n

Clinuvel is headquartered in Melbourne, but most of the action takes place across operations in the US, Europe and Singapore.<\/p>\n

\u00a0<\/p>\n

About Scenesse <\/h2>\n

Scenesse is the first drug in the world for EPP, with the mechanism of action of preventing anaphylactoid reactions and burns. <\/p>\n

With around 5000 to 10,000 sufferers globally, EPP is an inherited metabolic disorder caused by the buildup of protoporphyrin, which causes extreme light sensitivity and pain attacks upon visible light and ultraviolet radiation.<\/p>\n

Known as \u2018shadow chasers\u2019, EPP sufferers can only go outdoors at night.<\/p>\n

A sub-cutaneous formulation of the peptide afamelanotide, Scenesse binds to the melanocortin-1 receptor on skill cells and spurs a \u201ccascade of cellular events\u201d to activate melanin and create a prophylactic barrier. <\/p>\n

About the size of a rice grain, the Scenesse shots are injected subcutaneously in a 16 milligram dose and last for two months.<\/p>\n

The drug is now widely reimbursed, including in the US where the treatment costs an average $90,000 to $140,000 annually, depending on the number of injections required. <\/p>\n

\u00a0<\/p>\n

Back to the future<\/h2>\n

Clinuvel outlines a vision of creating a \u201chouse of melanocortins\u201d, equating to a total addressable market of $US44 billion.<\/p>\n

This includes the $US6.2 billion photo cosmetics sector.<\/p>\n

The beauty stuff?<\/p>\n

In a \u2018back to the future\u2019 move, Clinuvel has turned its gaze to over the counter safe bronzing\u201d products, albeit mainly for vulnerable bathers most prone to skin cancer rather than Ken and Barbie beach babes.<\/p>\n

The unguents repairing the cellular DNA skin damage caused by sunburn.<\/p>\n

The first product, Cyacelle was pilot-launched in March last year, with a global launch expected this year pitched at \u201cselect communities and patients in need\u201d.<\/p>\n

\u201cAs the company evolves, our lodestar remains the same,\u201d Dr Wolgen says. \u201cWe look to develop novel therapies for patients with high, unmet medical needs.\u201d<\/p>\n

\u00a0<\/p>\n

Beyond EPP<\/h2>\n

Clinuvel is working on the pigmentation disorder vitiligo, which affects about 45 million people (Michael Jackson was a celebrity sufferer).<\/p>\n

Vitiligo causes the skin to go pale, generally in blotches. <\/p>\n

In October last year the company started recruiting for a 200-patient phase III combination trial (CUV 105).<\/p>\n

The subjects are darker-skinned patients on whom the disease can have the greatest impact.<\/p>\n

A further combination study (CUV 107) should start this year.<\/p>\n

Clinuvel is also eyeing xeroderma pigmentosum, or XP, a hereditary condition leading to a very high risk of skin cancer and other medical problems. <\/p>\n

Two phase II studies (CUV 151 and CUV 156) are ongoing.<\/p>\n

Clinuvel is also working on a fast-acting afamelanotide variant called Prenumbra, for strokes and vascular disorders. <\/p>\n

The company undertook a six-patient, proof-of-concept program for arterial ischaemic strokes and a phase I study (CUV 803) is ongoing.<\/p>\n

Afamelanotide is known to have a potent antioxidative effect, improving blood flow and increasing the delivery of oxygen and nutrients to deprived brain cells. <\/p>\n

Finally, Clinuvel is testing the natural hormone neuracthel (ACTH) as a skin repigmentation treatment.<\/p>\n

Neuracthel would be the company\u2019s first branded generic product.<\/p>\n

Proof of concept studies show ACTH can repigment skin in vitiligo patients in combination with ultraviolet B phototherapy.<\/p>\n

A read-out on a phase II monotherapy study is expected this year.<\/p>\n

\u00a0<\/p>\n

Finances and performance <\/h2>\n

Clinuvel posted a net profit for the December first half of $10.9 million, four percent lower than previously because of a higher tax bill but the 15th consecutive half-yearly surplus.<\/p>\n

Revenue from Scenesse sales was 10 percent higher at $35.7 million and the company also pocketed $3.36 million of interest on its cash, which stood at $174 million at the end of December.<\/p>\n

Costs increased 28 percent to $20.9 million because of expanded corporate activity, with a 10 percent rise in the headcount.<\/p>\n

Broker Morgans dubs the results as \u201cless than compelling\u201d with disappointing Scenesse revenue growth and a big rise in costs.<\/p>\n

Chief finance officer Darren Keamy the company has been selling Scenesse to an \u2018orphan\u2019 market for more than eight years, so can\u2019t be expected to maintain its initial growth rate of 20-30 percent.<\/p>\n

\u201cNevertheless we are still achieving growth [but] expect a maturation in the growth rates over time and that is what we are seeing now.\u201d<\/p>\n

Management describes European demand as \u201dconsistently strong\u201d, with US sales underpinned by the expansion of treatment centres to 70 sites.<\/p>\n

In March last year, Clinuvel said it would stop issuing quarterly reports. The company could have done so in 2018, owing to its profitability, but continued to issue them voluntarily to inform investors.<\/p>\n

Over the last 12 months Clinuvel shares have traded between $21.26 (late August 2023) and $14.12 (early October 2023).<\/p>\n

The stock peaked at $43 in September 2021.<\/p>\n

\u00a0<\/p>\n

Competition looms<\/h2>\n

Does Clinuvel face EPP competition?<\/p>\n

Mitsubishi Tanabe is carrying out a phase III extension trial of MT-7117, which is not a motorway but a small molecule that activates the melanocortin-1 receptor (MC1R), a protein involved in skin pigmentation and sunlight protection. <\/p>\n

Completed in 2019, a phase II study showed \u201cincreased duration symptom-free sunlight exposure\u201d in patients with EPP, as well as the related X-linked protoporphyria.<\/p>\n

A phase III trial was completed in 2020, but the results are yet to be disclosed. <\/p>\n

Morgans says the drug candidate \u2013 which has FDA fast-track status \u2013 has a fair chance of success. <\/p>\n

\u201cHowever we see Scenesse remaining a cash cow beyond 2030, with a strong and growing specialist network and a monopoly in an underpenetrated market.\u201d<\/p>\n

\u00a0<\/p>\n

Succession \u2013 but no Shivs<\/h2>\n

Succession planning is top of mind at Clinuvel, because Dr Wolgen\u2019s contract expires in June 2025 while Keamy hangs up his abacus in June this year.<\/p>\n

But the company is quick to quell any notion of a Game of Thrones or Roy family-like power struggle.<\/p>\n

\u201cWe have clear profiles and processes in place to lead the company,\u201d Dr Wolgen says.<\/p>\n

\u201cThe new leadership team will be inducted into Clinuvel over a transition period, during which incumbents will be gradually phased out.\u201d<\/p>\n

In view of this Dr Wolgen was absent from the post-results investor hook up, with Keamy, global operations head Lachlan Hay and investor relations head Malcolm Bull conducting the dog-and-pony show.<\/p>\n

\u00a0<\/p>\n

Dr Boreham\u2019s diagnosis: <\/h2>\n

Clinuvel might be in a funk share-price wise, but its multiple clinical programs would seem to have a decent chance of success. <\/p>\n

The body-beautiful stuff \u2013 if we can call it that \u2013 also addresses a huge market but there\u2019s a lot to play out before the company becomes a household name.<\/p>\n

Along the way, Clinuvel can\u2019t be accused of burning investors with constant dilutive capital raisings: the company has the same number of shares on issue \u2013 just under 50 million \u2013 as when we last covered the stock in November 2022.<\/p>\n

Hay says the debt-free company is in a much better position than expected at the onset of the pandemic, when it was thought an equity raising would be needed.
\n\u201cI\u2019m pretty content today,\u201d he purred.<\/p>\n

Investors are not so sanguine: at last year\u2019s AGM, the company suffered a first \u2018strike\u2019, with 39 percent of voting investors rejecting the remuneration report. A \u2018strike\u2019 is incurred with a no vote of 25 percent or more.<\/p>\n

Dr Wolgen says it is \u201cfutile\u201d to dwell on the lack of correlation between share price and performance, given other companies similarly are affected \u201cto the dismay of all shareholders.\u201d<\/p>\n

A vital part of Clinuvel\u2019s success, Dr Wolgen draws inspiration from Dave Wottle, the golf-cap wearing US runner who came from being last at 500 metres to win the 800 metre event at the 1972 Munich Olympics.<\/p>\n

\u201cThis team has defied all odds before and will do it again,\u201d he says of Clinuvel\u2019s management.
\n\u00a0
\nDisclosure: Dr Boreham is not a qualified medical practitioner and does not possess a doctorate of any sort. He has been last at the mid-point of many a race but sadly he has remained there at the finishing line.<\/em><\/p>\n

This article first appeared in Biotech Daily<\/a>.<\/p>\n

<\/span><\/p>\n

The post Dr Boreham\u2019s Crucible: Does Clinuvel\u2019s investor value run deeper than just \u2018makes Scenesse\u2019?<\/a> appeared first on Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"

In a recent whimsical \u2018news communique\u2019 to investors, Clinuvel Pharmaceuticals (ASX:CUV) chief Dr Phillipe Wolgen dwells on the \u201cthe scale of human suffering and senseless [more…]<\/a><\/p>\n","protected":false},"author":0,"featured_media":6668,"comment_status":"","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-6667","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-finance"],"yoast_head":"\nDr Boreham\u2019s Crucible: Does Clinuvel\u2019s investor value run deeper than just \u2018makes Scenesse\u2019? - Economic Herald<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/economicherald.net\/?p=6667\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dr Boreham\u2019s Crucible: Does Clinuvel\u2019s investor value run deeper than just \u2018makes Scenesse\u2019? 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