Serodus

Getting re-energised

Report | 5 January 2017

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Serodus has four key drugs in its portfolio, which are primarily focused on the complications of diabetes. Despite advances in managing glucose levels, there are still limited treatments for co-morbidities linked to the disease and none that alter the course of diabetes. Serodus’s experienced management team has acquired a portfolio targeting these indications. The lead product, SER150, is ready to advance into Phase IIb for diabetic nephropathy, following promising Phase IIa data. Serodus is in the process of delisting from the Oslo exchange and needs to raise c €35m to advance the four assets to value inflection points.

 Year-end: December2013201420152016E
Sales (€m)0.00.00.0N/A
Adj. PBT (€m)(1.3)(2.0)(3.6)N/A
Net Income (€m)(1.3)(2.0)(3.6)N/A
Adj. EPS (€)(0.11)(0.09)(0.13)N/A
Cash (€m)0.62.42.0N/A
EBITDA (€m)(1.3)(2.0)(3.6)N/A
Source: Serodus accounts. Note: Adjusted numbers exclude share-based payments and exceptionals.
  • Targeting complications of diabetes Serodus is a virtual biotech company with a very experienced management team. It has two drugs in the clinic, and two others that could enter Phase I in the next 18 months. Three are being developed for diabetes related indications and the fourth has orphan drug designation for pulmonary arterial hypertension (PAH). All of the drugs address significant unmet medical needs with major commercial potential.
  • Lead product SER150 ready to enter Phase IIb Serodus acquired SER150 from Evolva after issues with liver toxicity in a Phase IIa trial. The very high dosing of the drug (300mg BID) did however show SER150 was efficacious in various complications of diabetes. A new, recently completed Phase IIa study with only 15mg and 30mg BID showed signs of efficacy and there were no safety signals at all. A Phase IIb study in 300 patients could start in H118.
  • Far from being just a one trick pony The other diabetes related drugs are SER140, which has the potential to stop progression of Type 2 diabetes, based on preclinical studies; and SER130, which is ready to enter the clinic for the reduction of scarring in patients with myocardial infarction. Its final product is SER100 for PAH is ready to enter a Phase IIa trial.
  • Delisting with a view to raise c €35m Serodus will be delisted from the Oslo Axess Stock Exchange on 16 February and will then look to raise sufficient capital to advance its portfolio. Management estimates that it needs to raise c €35m to advance all of its assets through value inflection points and that this will be easier to achieve without the limitations of being a Oslo-listed company. The recent Phase IIa supports Serodus’ thesis about the safety and efficacy of SER150 in a blockbuster indication, and suggests that the company is materially undervalued on the Oslo exchange.

Report

5 January 2017

Price (NOK)2.75
Market Cap (NOKm)122
Enterprise Value~ €13m
Shares in issue44.5m
12 month range (NOK)1.06 -3.69
Free float100%
Primary exchangeOslo Axess
Other exchangesNA
SectorHealthcare
Company CodeN/A
 NOK/EUR9.0 
Corporate clientYes

Company description

Serodus is a private Scandinavian drug development company focused on the complications of diabetes. Its lead asset is SER150, which is in Phase II for diabetic nephropathy.

Analysts

Mick Cooper PhD
mcooper@trinitydelta.org
+44 (0) 20 3637 5042

Franc Gregori
fgregori@trinitydelta.org
+44 20 3637 5041

Serodus: Getting re-energised

Serodus is primarily focused on developing drugs for the rapidly growing diabetes market (Exhibit 1). The WHO estimate that the number of people globally with diabetes has increased from 100m in 1980 to 442m in 2014 and that the prevalence among adults has risen from 4.7% to 8.5% during the same time period. There have been new therapies to help diabetics controlling their glucose levels, but there are so far limited treatments for the complications of diabetes and none that can be truly called disease modifying.

The company has a very experienced management team with successful track records of taking products to market and executing licensing deals (see biographies). It operates as a virtual company with only six employees, with all drug discovery and development activities outsourced to established CROs. 

The company’s initial therapeutic focus was on cardiovascular diseases and the first drug that it in-licensed was SER100 from Zealand Pharma for pulmonary hypertension. In 2014, Serodus in-licensed SER150 (EV-077) from Evolva and has since shifted its attention to diabetes and co-morbidities.

Exhibit 1: The Serodus pipeline
Source: Serodus Note TXA2: thromboxane receptor; TS: thromboxane synthase; BID: twice daily; PK/PD: pharmacokinetic/pharmacodynamic; db/db mice have the leptin receptor mutated and spontaneously develop diabetes; AMI: acute myocardial infarction; AE: adverse event

Serodus had a cash position of NOK9.13m (€1.0m) at Q316. The company estimates that it needs to raise c €35m to advance all of the products in its pipeline through value inflection points, with priority given to the development of SER150 and SER140, both of which have clear blockbuster potential.

 

Company information

Contact details

Serodus ASA
c/o Borgersen & Partners
Akersgate 45
0158 Oslo

Tel: +(1) 301 944 1700

www.serodus.com
post@serodus.com

Key personnel

PersonPositionBiography
Svein S. JacobsenNon-Executive ChairmanElected Chairman in 2012. He also serves as Chairman of Strongpoint, Fluid Control, Presentasjonsdata, Ericsen & Horgen, and Falkenberg. Previously, he was CFO and VP of Finance of Tomra Systems ASA, from 1984 and CEO and President from 1988 to 1996.
Dr Eva SteinessCEOJoined Serodus in 2010. From 1989 to 1998 she was Exec VP for R&D at Lundbeck and was responsible for the development of Cipramil (citalopram), the blockbuster antidepressant drug. In 1998 she founded Zealand Pharma and was CEO until 2007 and led the development of lixisenatide (Lyxumia) for Type 2 diabetes. She has also been Chairman of Genmab, a Director of several Lundbeck affiliates, and Chairman of the Danish Governmental Advisory Board on Research Politics.
Tore KvamCFOJoined in 2014. Tore Kvam has worked for over 15 years as CFO in both early stage and established companies, including CellCura, Rubik Solution Group, and Factor Insurance Group.
Dr Jurgen LangharigVP Business DevelopmentJoined in 2015. Jurgen Langharig has over 30 years of experience in international marketing/business development having worked at Sandoz (now Novartis), Nycomed (now Takeda), Novo Nordisk, Zealand Pharma and most recently was VP Business Development at Bavarian Nordic. .
Dr Nikolai BrunJoined in 2015. Nikolai Brun has worked in clinical development since 2000, having worked at Novo Nordisk, Genzyme and Genmab on the development of drugs spanning many therapeutic areas. Most recently, he led Genmab’s development of daratumumab (Darzalex).

Top 5 institutional shareholdings

No. of shares (m)% holding
Viggo Harboe Holding 200612.628.3
Danske Bank5.111.5
Bjorns Invest3.88.5
Eva Steiness2.35.1
MP Pensjon PK1.84.0

Source: Serodus

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