Byroncapitalmarkets.com

January 17, 2013
Merus Labs International Inc.
(MSL – TSX; MSLI - NASDAQ, $1.07)
Rating: SPECULATIVE BUY
Expands European Partnership Base for What Is
Target Price: N/A
Now Its Lead Product in Enablex/Emselex
Changes Today?
 Solidifies Growth Prospects for Urology Drug Enablex-Emselex with
Promotion Agreements in Niche European Markets: Merus Labs
International Inc. (Merus) is firmly focused on driving sales growth for Share data
what is now its leading pharma product in urinary incontinence drug darifenacin (Novartis’ Enablex/Emselex) by consummating several co- promotion agreements in Europe for the drug. New co-promotion partners are with relatively small regionally-focussed firms, including POA Pharma Scandanavia AB in Nordic nations (POA is a newly- Company Description: Merus Labs is an emerging
founded specialty pharma firm headquartered in Goteborg, Sweden specialty pharmaceutical firm, focused on com- targeting multiple therapeutic areas, including urology), Proximum mercializing mature pharma assets in niche medical d.o.o. in Croatia (Zagreb-based pharma firm; lead product is hyaluronic markets. Lead products include antibiotics Vancocin and Factive, and urinary incontinence drug Enablex. acid-based cosmetic brand Restylane) and SPCare Lda in Portugal. Each of these niche European markets may seem minor compared to Merus’ overall Enablex-Emselex market opportunity, but they cumulatively represent 20% of T12M sales of US$23 million. We recall that Spain/Portugal was a market where Labopharm’s once-daily Tramadol sales by partner Esteve SA were surprisingly strong and above sales generated in larger markets like France, Germany and Japan. And with Merus’ first quarter of Enablex-Emselex sales post-acquisition from Novartis of only $3.9 million (well below T12M sales on a run-rate basis), we believe Merus should at least explore the possibility that Enablex-Emselex sales trajectory could be promotion-sensitive.  Enablex-Emselex Is a Relative Newcomer to the Crowded Urinary
Incontinence Market, So Some Promotional Efforts Make Sense:
There are certainly signs beyond Merus’ Q4/F12 data that Enablex- Emselex recent sales growth is modest. In the U.S., where NJ-based specialty pharma firm Warner Chilcott owns distribution rights, Q3/F12 prescription volume declined 17% YoY even though sales held firm at US$45 million on price increases (as reported for other peer drugs in the quarter, like Allergan’s Sanctura XR) and reduced volume discounts. Originally FDA-approved in Dec/04, Enablex competes with at least five other anticholinergic drugs for treating overactive bladder, and we assume some if not all of these agents are E.U.-approved as well. Generic formulations for the major brands (but not yet for Enablex) are already available. Peer anticholinergic agents include: J&J’s extended-release oxybutynin form Ditropan XL (original drug Ditropan approved in 1976 but XL approved in Dec/98, genericized by Impax and Mylan in Nov/06, also available in topical forms Oxytrol patch and Gelnique gel), Pfizer’s tolterodine form Detrol (Q3/12 global sales of US$176 million down 17% YoY; approved in Mar/98, genericized by Mylan in Nov/12 and by Apotex in Sept/12), Allergan’s Douglas W. Loe, Ph.D. MBA
Merus Labs International Inc.
trospium form Sanctura XR (approved in Aug/07, generic already approved by Watson in Oct/12), Astellas’ solifenacin form Vesicare (F11 sales ¥97.2 billion; approved in Nov/04 with new adrenergic receptor agonist mirabegron/Myrbetriq was just FDA approved in Jul/12, E.U.-approved in Jan/13 as Betmiga), and more recently, Pfizer’s fesoterodine form Toviaz (Q3/12 global sales of US$52 million, up 6% YoY; approved in Oct/08). There is limited data in the medical literature comparing these agents to each other instead of to placebo, but where meta-analyses have been conducted on anticholinergic drugs as a class, all candidates seem to have overlapping benefits and side effect profiles (all confer dry mouth to some degree, for example). U.S. data from Consumer Reports shows average monthly Rx cost is similar for branded agents in the U.S. market, though obviously lower for generic forms of oxybutynin and tolterodine. Accordingly, with few differentiation features among Enablex’s anticholinergic urinary incontinence peers, other than perhaps oxybutynin’s longer clinical history, the market is one that should be  Summary: We maintain our SPECULATIVE BUY rating on Merus, with the firm’s existing
portfolio of C.difficile infection-targeted oral vancomycin brand Vancocin (acquired from Iroko), lung infection fluoroquinolone Factive (acquired from Cornerstone), and more recently Enablex-Emselex (acquired from Novartis as stated) performing well in recent quarters despite pending risks. In Q4/F12, the first financial period incorporating Enablex- Emselex sales, revenue/EBITDA/margin of $5.0 million/$3.7 million/73.8% was historically strong for the firm, and full-year F2012 EBITDA margin of 58.4% was at the top end of Merus’ specialty pharma peer group. Despite the now-substantial debt burden of $54.1 mil ion that Merus’ incurred to fund Enablex-Emselex acquisition, debt/EBITDA run- rate ratio of 3.7x is not outlandishly high for a rapidly-growing pharma firm in the early days of its, well, rapid growth, and EBITDA/interest ratio of 2.6x was solidly above threshold warning levels for us of 1.5x – 2.0x. We of course anticipate revenue erosion for Vancocin in a Canadian market where generic oral vancomycin is now available from PPC (offset by Q1/F13 seasonal strength), but generic pricing is set as high as 74% of branded pricing in some provinces, which should partially mitigate pace of sales erosion. As well, Enablex-Emselex European sales growth in promotion sensitive geographies could mitigate Vancocin sales risk, possibly as early as F2013/14. There were no economic details shared on the Enablex-Emselex co-promotion deals announced on Thursday, but as would be conventional, new partners will likely receive a proportion of sales beyond historic levels that each generates in partnered markets. Such an arrangement will inevitably compress Merus’ EBITDA margin somewhat, but should still be accretive to Douglas W. Loe, Ph.D. MBA  647.426.0472  DLoe@byroncapitalmarkets.com Merus Labs International Inc.
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The security represents extremely compel ing value and is expected to appreciate significantly from the current price over the next 12-18 month time horizon. The security represents attractive value and is expected to appreciate significantly from the current price over The security is considered a BUY but in the analyst’s opinion possesses certain operational and/or financial The security represents fair value and no material appreciation is expected over the next 12-18 month time The security represents poor value and is expected to depreciate over the next 12-18 month time horizon.
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