1. Interesting comments during Q&A around the 55-minute mark as the caller asks about the combinability of TMC435 w/other nukes and includes reference to IDX-184, along with GS-7977 and BMS-094. In regards to IDX-184, the speaker talks about how it has been on partial hold and there might be issues w/safety that might limit optimal dosage of IDX-184 but we don't know that yet. (Doesn't sound like JNJ/Medivir is a potential partner for IDX-184 though.) In regards to whether TMC435 would work better with GS-7977 or BMS-094, the speaker actually says he can't see any difference between them in terms of combining with TMC435 as both are nuke triphosphates and he can't see much difference or a favorite between the two. (I found those comments a bit surprising.)
· Net sales were SEK 285.1 (444.6) m of which one-off payments were SEK 0.0 (401.2) m, pharmaceutical sales were SEK 85.2 (16.3) m and parallel import sales were SEK 199.9 (26.6) m · Profit/loss after tax amounted to SEK -98.6 (220.3) m · Basic and diluted earnings per share were SEK -3.15 (7.37) · Cash flow from operating activities amounted to SEK -51.0 (230.9) m; cash and cash equivalents and investments in securities etc. amounted to SEK 409.6 (716.4) m at the end of the period
Second quarter (April - June 2012)
· Net sales were SEK 147.2 (322.9) m of which one-off payments were SEK 0.0 (279.8) m, pharmaceutical sales were SEK 38.9 (16.2) m and parallel import sales were SEK 108.3 (26.6) m · Profit/loss after tax amounted to SEK -60.9 (167.4) m · Basic and diluted earnings per share were SEK -1.95 (5.52)
Business highlights in the second quarter
· Clinical collaboration extended on Bristol-Myers Squibb’s daclatasvir (BMS-790052) on interferon-free combination trials with TMC435 (simeprevir) · Janssen started up a new division, Janssen Therapeutics EMEA, to launch TMC435 (simeprevir) in Europe · Positive final phase IIb data for TMC435 (simeprevir) in hard-to-treat hepatitis C patients presented · Henric Juserius appointed as Executive Vice President of the company’s commercial operations · Clinical phase I trials on MIV-711, a cathepsin K inhibitor, commence · Partnership commences with the Swedish University of Agricultural Sciences (SLU) to develop new pharmaceuticals against bacterial infections
Business highlights after the end of the second quarter
· Clinical phase Ia trials with the cathepsin K inhibitor MIV-711 completed and phase Ib trials commence
* All figures for the group unless otherwise stated. In this Interim Report, comparisons are with the corresponding period of 2011 unless otherwise stated. The BioPhausia group is included from 31 May 2011.
CEO’s comment on the second quarter of 2012
“Good progress in all parts of the company” We continued to develop Medivir into a profitable Nordic pharmaceutical company, and made good progress in all parts of the company. Sales of original pharmaceuticals progressed as planned, and made continued stable progress in the second quarter. Parallel imports, through Cross Pharma, are operating on an expansive and fast-moving market where our experience and long-term commitment continued to create value.
TMC435 gained its generic name - simeprevir. Phase III trials on simeprevir continued as planned and new data presented in the period confirmed simeprevir’s good prospects of becoming an essential component in the optimal triple therapy for hepatitis C (HCV). Simeprevir’s competitive profile also engenders good hopes of an important role in future interferon-free therapies. Extensive phase II trials have demonstrated good safety and efficacy, not least in the hardest-to-treat patient groups where there is the greatest need for therapy.
The company’s proprietary projects progressed as planned. In May, phase I trials commenced on our in-house developed cathepsin K inhibitor MIV-711, for treating skeletal disorders. We also have strong hopes of being able to designate a nucleotide CD in our own early HCV projects before year-end. In June, we initiated a partnership with the Swedish University of Agricultural Sciences (SLU) in Uppsala on the development of new antibiotics against resistant bacteria, a project that is consistent with our strategy.
Henric Juserius was appointed as our new Commercial EVP in the quarter, and took up his position in August. We also integrated our clinical development operations into our R&D organization, which meant that Jens Kristensen left the company at the end of July.
The company’s business operations The Pharmaceuticals business area
GlaxoSmithKline’s European launch of Medivir’s in-house developed cold sore pharmaceutical Xerclear® in five countries, under the Zoviduo and Zovirax Duo brands, continued in the second quarter. As the product is launched in additional European countries, its value in Medivir’s accounts will become more visible.
Parallel imports in Cross Pharma The positive sales trend continued. In the second quarter, sales were SEK 108.3 (26.6) m, showing a sales growth for the seventh consecutive quarter. However, the investment in Cross Pharma, through means including an express initiative to register new pharmaceuticals to extend the portfolio, continued to reduce Cross Pharma’s operating margin. EBITDA was SEK 3.0 (0.2) m.
R&D Simeprevir (TMC435) - Medivir’s protease inhibitor in clinical phase III for treating hepatitis C Phase III trials on simeprevir progressed as planned during the period and we expect to be able to present initial data from these trials around the coming year-end. From extensive phase II trials, we know that simeprevir addresses needs in all patient groups effectively and safely, simultaneous with this compound being easy to administer, possible in a single day tablet dose. Good efficacy is especially important in the hardest-to treat and most severely affected patient groups. The strength of the results from treatment-naïve and treatment-experienced patients in phase IIb trials demonstrate that through its mechanism of action, simeprevir will be an important component in future interferon-free treatments.
Combination therapy is a prerequisite for realizing interferon and ribavirin-free treatments. In July, a phase II trial commenced designed to study combination treatment with simeprevir and daclatasvir from Bristol-Myers Squibb. This trial is another key step in collecting data for future combination therapies with simeprevir as a solid cornerstone. The combination trial in phase II on simeprevir and Gilead’s nucleotide inhibitor GS7977, which commenced at the beginning of the year, progressed well. We hope to be able to present the first partial results from this trial before year-end.
Hepatitis C projects in-house Our own preclinical HCV projects progressed as planned in the second quarter. As previously, our goal is to be able to designate a CD in the nucleotide project before year-end.
Cathepsin K Phase I trials on our in-house developed CD MIV-711, for treating skeletal disorders, commenced in May. Phase Ia trials with increasing single doses to evaluate safety, tolerance and pharmacokinetics on healthy individuals concluded recently. The results were promising and phase Ib trials have commenced that will examine the treatment of healthy trial subjects for 7-14 days at increasing doses. These trials also include measuring markers of cartilage and bone resorption.
Maris Hartmanis CEO and President
For more information, please contact: Rein Piir, EVP Corporate Affairs & IR, +46 (0) 70 853 7292 Maris Hartmanis, CEO: +46 (0)8 546 83113
Conference call for investors, analysts and the media The Interim Report will be presented by the CEO, Maris Hartmanis, and members of Medivir’s management.
Time: 2 p.m. (CET) on Thursday, 23 August 2012
Participant telephone numbers: Sweden +46 (0)8 505 204 24 Europe +44 (0) 20 3003 2666 USA +1 866 966 5335
The conference call will also be streamed via a link from the website www.medivir.com
Financial information in 2012 The Interim Report for January-September will be published on 20 November The Financial Statement for January-December will be published on 22 February 2013
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