CLINUVEL PHARMACEUTICALS LIMITED
 

CUV Details

FDA ApprovesSCENESSE® For Genetic Disorder: CLINUVEL PHARMACEUTICALS LIMITED (ASX: CUV) is engaged in the development of SCENESSE®, its leading drug candidate for the treatment of skin disorders. The company recently notified that it has secured the approval of the US Food and Drug Administration (US FDA) for SCENESSE®to be used in the treatment of a rare genetic metabolic disorder causing absolute intolerance to light.

Employment Renewal with CEO: As per another recent update on ASX, the company has renewed the Employment Agreement with Philippe Wolgen, currently Managing Director of Clinuvel, for 3 years to 1 July 2022.

Dividend Update: On 19 September 2019, the company paid a dividend amounting to AUD 0.0250 per ordinary share. Dividend on FY19 represented an increase of 25% on prior corresponding year dividend of AUD 0.020.

FY19 Financial Highlights: During the 12 months ended 30 June 2019, the company generated total revenue amounting to $31.05 million, up 22% in comparison to revenue of $25.49 million in the prior corresponding period.Operating cash flows for the period stood at $18.46 million, up in comparison to the prior corresponding period cash flows of $11.69 million. Net profit before tax stood at $18.12 million, up 40% on prior year’s profit of $12.94 million. Earnings per share witnessed a year-on-year increase of 35.7%.


FY19 Financial Summary (Source: Company Reports)

Outlook: Going forward, the company is planning to expand its European business through further growth in European distribution.It is eyeing to enter the US market, which is dependent upon FDA’s approval for the distribution of SCENESSE®to EPP patients. In addition, it is looking forward to build upon its product development pipeline for a range of skin related indications.

Stock Recommendation: The stock of the company generated returns of 4.62% and -17.79% over a period of 1 month and 3 months, respectively. FY19 came in as a period of record annual net profit with a solid base of earnings for the European business. The proposed expansion for the European business is expected to value accretive in the future. The company expects to attain long term profitability through research and development centred around SCENESSE® while simultaneously maintaining financial discipline and stability in the business.

Currently, the stock is trading close to its 52-week high level of $45.880 and has a market capitalisation of ~$1.38 billion. The recent announcement regarding FDA’s approval for SCENESSE® for a rare skin disorder lifted the share price to a record high of $45.880 on 09 October 2019. Considering the above scenario and current trading levels, we presume that majority of the positive developments have been discounted at the current juncture and thus, we suggest investors to book profit and recommend a “Sell” rating on the stock at the current market price of $45.000, up 60.199% on 09 October 2019.

 
CUV Daily Technical Chart (Source: Thomson Reuters)
 

Orthocell Limited

OCC Details

CelGro® Gaining Traction in Key Markets: Orthocell Limited (ASX: OCC) is engaged in the development and commercialisation of cell therapies and related technologies. The company recently notified that the clinical trial for the use of CelGro® in enhancing repair of peripheral nerves reported positive results. Post-surgery with CelGro®, the patients regained muscle function with a significant reduction or abortion of prescription pain medication.

Shareholding Update: As per another recent announcement, AustralianSuper Pty Ltd ceased to be a substantial shareholder of the company.

Highlights of FY19 Results: During the period ended 30 June 2019, revenue from product sales amounted to $0.94 million, up 53% in comparison to prior corresponding period revenue of $0.33 million.During the year, the company reported a net loss for the period amounted to $5.85 million as compared to a loss of $5.76 million in FY18.
  

Income Statement of FY19 (Source: Thomson Reuters)

What to Expect: The company expects to deliver a significant shareholder upside in the near term on the back of CelGro®’s growing popularity in key markets.The company expects to deliver further growth in the business by securing US approval for CelGro®. In addition, it is looking forward to the commercialisation of Ortho-ATI® through research collaboration with a major US partner.

Stock Recommendation: The stock of the company generated returns of 182.14% over a period of 6 months and has a market capitalisation of $60.97 million. In 2019, the company achieved significant milestones in executing its partnering strategy for CelGro® as a dental bone repair product. In addition, it is progressing well on the planned clinical trial of Ortho-ATI® versus corticosteroid injection. The share price soared by around 20% on 09 October 2019, following the announcement of positive results from the clinical trial of CelGro®, with patients significantly reducing their prescription medication after undergoing CelGro®’s treatment. Considering the above factors in conjunction with the high returns on stock, we give a “Sell” recommendation on the stock at the current market price of $0.475, up 20.253% on 09 October 2019.

 
 OCC Daily Technical Chart (Source: Thomson Reuters)

Disclaimer
 
The advice given by Kalkine Pty Ltd and provided on this website is general information only and it does not take into account your investment objectives, financial situation or needs. You should therefore consider whether the advice is appropriate to your investment objectives, financial situation and needs before acting upon it. You should seek advice from a financial adviser, stockbroker or other professional (including taxation and legal advice) as necessary before acting on any advice. Not all investments are appropriate for all people. Kalkine.com.au and associated pages are published by Kalkine Pty Ltd ABN 34 154 808 312 (Australian Financial Services License Number 425376). The information on this website has been prepared from a wide variety of sources, which Kalkine Pty Ltd, to the best of its knowledge and belief, considers accurate. You should make your own enquiries about any investments and we strongly suggest you seek advice before acting upon any recommendation. Kalkine Pty Ltd has made every effort to ensure the reliability of information contained in its newsletters and websites. All information represents our views at the date of publication and may change without notice. To the extent permitted by law, Kalkine Pty Ltd excludes all liability for any loss or damage arising from the use of this website and any information published (including any indirect or consequential loss, any data loss or data corruption). If the law prohibits this exclusion, Kalkine Pty Ltd hereby limits its liability, to the extent permitted by law to the resupply of services. There may be a product disclosure statement or other offer document for the securities and financial products we write about in Kalkine Reports. You should obtain a copy of the product disclosure statement or offer document before making any decision about whether to acquire the security or product. The link to our Terms & Conditions has been provided please go through them and also have a read of the Financial Services Guide. On the date of publishing this report (mentioned on the website), employees and/or associates of Kalkine Pty Ltd do not hold positions in any of the stocks covered on the website. These stocks can change any time and readers of the reports should not consider these stocks as advice or recommendations.