In what we view as something of a coup for NeuroSearch, The Lancet has published the results of the tesofensine Phase II Proof-of-Concept TIPO-1 study.
However, without taking anything away from the company, we would remind
investors that this is not new news; the main part of the results have previously
been presented at various locations including the 16th European Obesity congress on May 23 but in continuing to build the tesofensine case all new details are
Nonetheless, biotech is a high risk/high reward story. NeuroSearch’s shares have fallen from DKK278 on 2. September 2008 to a closing price of DKK158 on
October 22, in our view a reflection of volatility and risk aversion in the markets
rather than the opportunities open to NeuroSearch. All preparatory
documentation for the Phase III trial of tesofensine has been completed and the company will work with the EMEA and FDA on this before initiating the studies.
Jacob Thrane
We believe Investors are awaiting news on the Phase III trial, but in our view NeuroSearch needs to find a commercial partner given the sheer size of the study
and estimated cost of up to EUR100 mln, according to the company. Moreover,
as GPs will remain in the frontline of tackling obesity, promoting tesofensine
would require a sales force and marketing apparatus beyond the strategic scope of NeuroSearch. We expect a deal to be announced within the next six months as CEO Flemming Pedersen sees the “partner landscape more positive than ever”, according to Børsen. While more upbeat than usual, nothing more was added.
In the absence of an agreement, NeuroSearch intends setting the wheels in motion for its own, albeit limited Phase III trial to de-risk the project for a potential partner, and according to Bloomberg, chairman Thomas Hofman-Bang
says a financial partner is a possibility. After contacting the company, we understand that a partner will provide bridge finance until a commercial deal is signed without NeuroSearch surrendering any rights or this leading to any dilution. On the basis that we continue to await real progress, we maintain our Buy (****) recommendation and DCF-derived 12-month target price of DKK339
(using a WACC of 8.6% and terminal growth rate of 3.0%).
Source: S&P Equity Research estimates
Source: Company data, S&P Equity Research estimates
Source: Company data, S&P Equity Research estimates
Estimate arrows indicate a change equal to or greater than 5% since last published report.
This report is for information purposes and should not be considered a solicitation to buy or sell any security. Neither Standard & Poor’s nor any other party guarantees its accuracy or makes warranties regarding results from its usage. Redistribution is prohibited without written permission. Copyright 2008. All required disclosures and analyst certification appears on the last 3 pages of this report. Additional information is available on request.
Tesofensine offers a potential breakthrough in the treatment of obesity, with
strong results from the Phase II trials. While we are confident NeuroSearch will
find a Phase III partner, investors should note that most drugs in this area have
not shown the same efficacy and Sanofi’s Acomplia (SAN FP, Buy) was not
approved in the US due to adverse psychiatric side effects, and as such we
believe potential pharma partners will need reassurance before committing.
Progress on competitors’ anti-obesity drugs have suffered serious setbacks
recently. Pharmacologically unrelated to rimonabant (Acomplia), tesofensine is a
monoamine reuptake inhibitor and as such works differently to now off-patent
sibutramine (Reductil/Meridia from Abbott Labs (ABT US, Strong Buy)).
Additionally, Merck (MRK GR, Buy) cancelled all further development on its Phase
III anti-obesity candidate taranabant (a cannabinoid Type-1 receptor antagonist,
CB-1) in early October, citing dose-response related efficacy and adverse side
effects. We believe these side effects to be psychiatric (Acomplia is also a CB-1
antagonist) and with Pfizer’s (PFE US, Hold) end-of-September announcement of
the termination of its obesity research, the future for its CB-1 drug candidate, CP-
945598 (otenabant), in our view looks bleak.
Against this backdrop and combined with the strong Phase II results, we believe
tesofensine should sell itself, given the huge medical need (e.g. 27.4% of the US
adult population (> 20 years) is currently classified as obese, BMI>30, according
to data from the American Centers for Disease Control and Prevention). We
appreciate that the path to NeuroSearch finding a partner will involve complex
negotiations, but we also believe that there is a limit to how long this can go on
without investors becoming concerned. NeuroSearch is, in our view, keen to
demonstrate the necessary momentum, notwithstanding the financial details of
ongoing partnership negotiations and, according to the company, will not rule
out going for a narrower indication, e.g. extreme obesity (BMI>35) or obesity with
co-morbidity (BMI>30) to get tesofensine approved and on the market, but also
believes it could then charge a higher (sales) price for tesofensine, hence
sustaining projected income. This would be followed by an active pursuit of an
In our view this indicates NeuroSearch has put a value on tesofensine that will be
reflected in the price it would expect a potential partner to pay in a licensing
agreement. With the patent expiring in December 2017, we argue that the last-lap
bell is about to ring for full-scale trial initiation, and NeuroSearch is fully aware of
We estimate tesofensine represents an NPV based on a Phase III probability-
adjusted royalty income of DKK1,505 mln or DKK96 per share. In our estimates we
currently reflect a milestone payment from a potential tesofensine partner in Q4
08, but moving this to Q1 09 has only a negligible impact on our valuation. On the
basis that we await real news, we reiterate our Buy (****) recommendation and
12-month DCF-derived target price of DKK339 (using a WACC of 8.6% and
Downside risks to our target price and recommendation include:
Negative clinical trial results for ACR-16, ABT894 or tesofensine;
The FDA requiring further trials and investigations on tesofensine based on
Payer resistance to reimbursement on tesofensine;
Inability or complications in signing a partner for the continued Phase III
Complications in or the termination of signed strategic partner agreements;
Failure and/or suspension of any of the other pipeline candidates.
Fiscal year end December (DKK mln)
Extraordinary/exceptional itemsNet profit, adjusted
Growth Revenues (%) Margin Gross margin (%) EBITDA margin (%)
Source: Company data, Standard & Poor’s Equity Research estimates
Fiscal year end December (DKK mln) Total non current assets Total current assets Total assets Total long-term liabilities Total current liabilities Total liabilities Total equity and liabilities
Source: Company data, Standard & Poor’s Equity Research estimates
Fiscal year end December (DKK mln) Operating cash flow Free cash flow
Dividend payments (net)Other payments (net)
Net cash flow
Source: Company data, Standard & Poor’s Equity Research estimates
Fiscal year end December (DKK mln)
Inventory turnover (days)Payables outstanding (days)
Source: Company data, Standard & Poor’s Equity Research estimates
Fiscal year end December (DKK)
Source: Company data, Standard & Poor’s Equity Research estimates
Fiscal year end December
Source: Company data, Standard & Poor’s Equity Research
Period end (DKK mln)
Gross profitEBITDA, reportedEBITDA, adjustedEBIT, adjusted
Source: Company data, Standard & Poor’s Equity Research estimates
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