Moberg Pharma AB (publ) is a Swedish pharmaceutical company focused on commercializing proprietary innovations based on drug delivery of proven compounds. The company’s main asset, MOB-015, is a novel topical treatment for onychomycosis, with recently completed phase 3 trials in more than 800 patients. The pipeline also includes the late-stage asset BUPI for pain relief in oral mucositis. Clinical data generated for both assets indicate they have the potential to become market leaders in their respective niches. Moberg Pharma is headquartered in Stockholm and the company’s shares are listed on the Small Cap list of the NASDAQ OMX Nordic Exchange Stockholm (OMX: MOB).
Securing a new terbinafine manufacturer for MOB-015 represents a key milestone that enables future launches. It means that the timeline for the company's launch rollout can be maintained, and that access to terbinafine is no longer a limiting factor for MOB-015. MOB-015 is already available to Swedish patients under the brand name Terclara® and we look forward to reaching patients in all 13 approved countries in the future, as there is a great need for a topical treatment that truly cures the nail infection
While the topline results of the North American study creates new conditions, the data reinforce the superior efficacy of daily dosing, which is already approved and thriving in the Swedish market. We now have the opportunity to establish a stronger presence in EU and capturing a larger part of the value chain for this great product
Terclara continues to be the market leader in Sweden and we could not have wished for a better start to the launch. For the U.S., we are lowering our expectations for the primary endpoint in the ongoing phase 3 study as we await the study results and subsequent analysis to understand the implications,
Our main priority is to protect the data integrity of the study. Together with our CRO, we will do our utmost to minimize the time from the last patient's last visit to top-line data, and our expectation is that these may be brought forward compared to the timelines previously communicated, before year-end.
We can look back at a successful launch in Sweden, where Terclara® has quickly become established and is now available at all Swedish pharmacy chains. The aim of the launch in Sweden was to achieve a market-leading position, which has already been accomplished,
When we designed the oversubscribed rights issue of units last summer, the intention was to raise approximately SEK 200 million, half of which through the TO 2 warrants. The outcome of TO 2, where the company raises 336 million SEK, is a testament to our strength and is expected to promote growth and shareholder value. TO 2 has also provided an opportunity to further strengthen our shareholder base. We appreciate the trust and look forward to dedicating our full efforts to execute on our launch plans for the drug MOB-015, with approval in 13 EU countries, and where our partner Allderma has brought the product to a market-leading position in Sweden under the brand Terclara®. The launch is proceeding as planned, and we welcome the new shareholders who have joined the company via TO 2 to share in our exciting journey ahead.
When we designed the rights issue of units last summer, the goal was to raise approximately SEK 200 million, half of which through the TO 2 warrants. The subscription commitments and the top guarantee mean that the company has now secured this capital free of charge. Any additional capital raised through the TO 2 warrants is expected to promote growth and shareholder value. TO 2 has also provided an opportunity to further strengthen our shareholder base, in addition to the continued support from our main shareholder Östersjöstiftelsen. We are pleased to have secured the financing and look forward to dedicating our time to executing our launch plans for the drug MOB-015, which has recently been approved in 13 EU countries and where our partner Allderma has taken the product to a market-leading position in Sweden under the brand name Terclara®
The warrants are part of our launch strategy for our drug MOB-015, which has recently been approved in 13 EU countries, and where our partner Allderma has already, in the first month with full marketing, taken the product to a market-leading position in Sweden under the brand name Terclara®
I am very pleased with the launch together with our partner Allderma. Terclara® is now available for those who want to begin the journey towards attractive, fungus-free nails before sandal season and summer vacation. It is an achievement to quickly reach a market-leading position, and the team in Allderma once again demonstrates that they are an excellent partner in our home market.
The launch to pharmacies was initiated in February. A majority of Swedish pharmacies now have MOB-015 available on the shelf under the brand name Terclara® and interest is exceeding the chains’ forecasts. The pharmacy chains are increasing their orders after consumer marketing began around the end of March due to the fact that the product occasionally has sold out at several of the pharmacy chains. However, there is a well-stocked wholesale warehouse
It is gratifying to see that as many as seven countries have issued approvals for OTC sales right from the start, as the largest sales volumes in Europe are expected to come from non-prescription sales. I’m delighted to conclude the series of national approvals with OTC approval for Italy, one of the largest nail fungus markets in Europe.
It is very rewarding to see MOB-015 launched in Sweden – the result of a multi-year effort by Moberg Pharma. I am incredibly proud that our medication is now available to patients who previously lacked good treatment options
The submission of the application to include an additional supplier is important to secure the supply of terbinafine ahead of the planned pan-European roll-out of MOB-015. MOB-015 is already available to Swedish patients and we look forward to reaching patients in more countries in the future, since there is significant need for a topical treatment that truly cures the nail infection
MOB-015 is now on the shelves of pharmacies around Sweden under the brand name Terclara® – a milestone we have been working towards at Moberg Pharma for some time. It is especially gratifying to see the great interest in the product among the pharmacies
It is incredibly rewarding to work with such a committed market partner as Allderma. The introduction of Terclara® to Swedish pharmacy chains has gone very well. Allderma's approach and good results demonstrate why they are an excellent partner in our home market.
We have high expectations for the launch of MOB-015 - the first topical medication with an equivalent antifungal effect to tablets but without the risk of serious side effects. The goal is the same as last time, to achieve a market-leading position.
Both the regulatory process, with additional national approvals during the quarter, and the North American study where patient enrollment has been completed are important achievements for the company,
First and foremost, I want to thank Agneta and Jesper for their outstanding contributions to Moberg Pharma and their contributions to the executive team. As part of our growth journey, I now welcome Christina and Robert to the Moberg Pharma executive team. Both Christina's extensive experience in the development of new drugs and Robert's extensive production experience will be highly valuable to the company
Completing the enrollment in North America well ahead of year-end is an important milestone and the result of excellent teamwork and committed investigators. I am very pleased with the progress and the rigorous screening process and positive collaborative atmosphere which increases the probability of strong phase 3 results
I would like to thank existing and new investors for their confidence in this rights issue. We are pleased to have secured the funding and look forward to fully devoting our time towards realizing our business goals, including the commercial launch planned to start in our home market Sweden as soon as possible. Moberg Pharma is in an exciting phase after MOB-015 was recommended for market approval in 13 European countries in June this year and we have already managed to get national approval in several of these markets
We are incredibly proud to bring a new efficacious treatment option with a favorable safety profile to people living with onychomycosis in Europe, an important part of our vision of making MOB-015 the leading nail fungus treatment worldwide,
Moberg Pharma is undergoing an exciting phase after MOB-015 is recommended for market approval in 13 European countries. The rights issue is a step in our continued development that ensures funding of clinical and regulatory activities for MOB-015 as well as preparations for launch. In connection with the financing, I want to thank our main shareholders, other existing shareholders and new investors for their trust in our business and continued growth journey
We are excited about the MOB-015 program, with its cutting-edge technology and the promising 76% mycological cure rate shown in the clinical trials. It is a good fit for our Canesten® brand, with potential to become a game changer within onychomycosis
We are incredible proud to bring a new efficacious treatment option with a favorable safety profile to people living with onychomycosis in Europe, an important part of our vision of making MOB-015 the leading nail fungus treatment worldwide
We remain fully focused on our two most important activities: the registration process for MOB‐015 in Europe and patient enrollment in the North American Phase 3 study. Both the registration process and the clinical study are progressing as planned,
We remain fully focused on our two most important activities: the registration process for the nail fungus treatment MOB-015 in Europe and patient enrollment in the North American Phase 3 study. Both the registration process and the clinical study are progressing as planned and we are now intensifying the preparations ahead of expected approval this year
The two most important activities in the near term for the company – the registration process for the nail fungus treatment MOB-015 in Europe and patient enrollment in the new North American Phase 3 study – are progressing according to plan. Together with our partners, we are continuing preparations ahead of the expected approval and initiation of launch next year
Patients are now being enrolled in the new North American Phase 3 study, which is fully financed thanks to the rights issue we carried out. Concurrently, the registration process for MOB-015 is underway in Europe, where the company submitted a registration application in March of this year and expects an approval and launch next year,
This is the sixth commercial agreement for MOB-015, this time with a leading provider of extended topical and other specialty pharmaceuticals in Israel. We look forward to work with Padagis and making MOB-015 available in Israel, contributing to our vision of making MOB-015 the leading nail fungus treatment worldwide
As a leading pharmaceutical company in Israel, Padagis Israel welcomes the signing of this agreement with Moberg Pharma and look forward to a fruitful cooperation and collaboration between the two companies
I would like to thank existing and new investors for the support in this rights issue. We are pleased to have secured the financing and look forward to devoting our time on executing on our business with full force. Our new North American Phase 3 study, where patient recruitment is ongoing, is fully financed and the capital injection gives us the opportunity to utilize MOB-015's full potential, both through registration activities and launch preparations in Europe. We now look forward to expected market approval in 2023, launching MOB-015 and creating long-term shareholder value
In March, the company submitted a marketing authorization application for MOB-015 in Europe – a key milestone in our journey to launch a new and improved nail fungus drug. The new North American Phase 3 study has started and is fully financed thanks to the guaranteed rights issue
The initiation of patient enrollment in the North American Phase 3 study for MOB-015 is a major milestone for Moberg Pharma
Our long-term vision is to become a global leader in onychomycosis and we believe that MOB-015 has the potential to establish a new standard of care. The Phase 3 study have been designed to support registration in North America and runs in parallel with the registration process in Europe where our goal is to receive first market approval and launch in 2023
The financing we have secured gives us the opportunity to fully exploit MOB-015’s potential, both through the registration activities and launch preparations in Europe and an additional clinical study for the US market. The demand for an effective drug for nail fungus is high and MOB-015 can achieve a unique market position through its high antifungal effect
Submitting the Marketing Authorization Application in Europe is a key milestone in our journey to launch a new and improved nail fungus drug. MOB-015 is uniquely positioned through its high antifungal efficacy, since there is significant need for a treatment that truly cures the nail infection
For market approval in the U.S., the FDA typically requires two studies that demonstrate statistical superiority of the active drug versus its vehicle (placebo) for the primary endpoint. The first study was successfully completed in 2019 and we are now conducting the second study. The North American study is a top priority in the near future, in addition to the registration process in Europe where our goal is to receive first market approval and launch in 2023.
The most important event in the quarter was that the Medical Products Agency in Sweden has agreed to be reference member state for MOB-015 in Europe. The company also signed a new collaboration agreement with Allderma for the launch in Scandinavia in 2023. In addition, preparations are fully underway for the new North American Phase 3 study,
We are advancing toward the company’s goal to register a new and improved nail fungus drug. The need for a treatment alternative that can truly cure the nail infection is great, which means that MOB-015 can achieve a unique position through its high antifungal effect
We would like to thank Peter for his valuable contributions to Moberg Pharma as chairman in recent years and previously as CEO of the company. The Nomination Committee will present its complete proposal for a new Board of Directors, including Peter’s replacement, well in advance of the Annual General Meeting.
Moberg Pharma is a very interesting company. We developed the company from the start to revenues of almost half a billion SEK before the commercial business was divested in 2019. The company's pipeline now includes MOB-015, which builds on previous successes and has demonstrated world-leading ability to cure patients from nail fungus. I look forward to continuing as Chairman until the AGM and to maintain close contact with the company as a major shareholder thereafter.
The approval from the EMA’s paediatric committee in September is an important milestone towards our goal to submit a registration application for MOB-015 in Europe this year and enables us to pursue a full marketing authorization application with data exclusivity in Europe for up to 10 years after market approval. Hand in hand with registration preparations, commercialization preparations are underway, including through the collaboration with Allderma ahead of the Scandinavian launch
Rapidly after launch, Nalox® became the market leader in the Nordics and grew the market by 400%. It is very valuable for us to repeat this successful cooperation for the launch of MOB-015, a drug with much greater potential. There is also a great advantage to be directly involved in an early launch prior to additional launches with our partners
We look forward to the launch of MOB-015, the first topical drug with equal antifungal efficacy as oral treatment, without the risk for severe side effects. The goal is the same as last time: to reach a market-leading position in Scandinavia
The approval enables data exclusivity in Europe for up to 10 years and further strengthens our intellectual property protection of MOB-015. It is an important milestone towards our goal to submit a registration application for MOB-015 in Europe this year
The registration preparations for MOB-015 are progressing as planned, with the goal to submit a registration application in Europe in the second half of 2021. Further discussions with regulatory authorities are scheduled this autumn and a final decision from the EMA’s Paediatric Committee is expected in September, which will determine the timing for submission of the registration application,
Registration preparations for MOB-015 are progressing at full speed, including recently received final comments on our pediatric plan from EMA. We remain on plan to submit the registration application in Europe in the second half of 2021. The spin-off of BUPI was completed through the IPO of OncoZenge in February
The patent significantly strengthens the intellectual property for BupiZenge® in Europe
It protects the use of BupiZenge® in all relevant indications for treatment of pain in the oral cavity
The great interest from well-reputed investors is very positive and enables BupiZenge® to further progress its clinical program and OncoZenge to become a listed company in the near future. I look forward to leading the continued development focusing on our upcoming Phase 3 study in an indication area with significant need for better treatment alternatives. The goal is to offer patients much better pain relief and to create value for our shareholders
