News

Medigene reports financial results for the first quarter of 2013

 

  • Increasing revenue with steady operating costs
  • Veregen® in-market sales show 47% growth
  • Press and analysts conference call with webcast (in English) today, 14 May 2013, 11:00 a.m. (CEST)

Martinsried/Munich, 14 May 2013. Medigene AG (MDG, Frankfurt, Prime Standard) today reported on its financial results and business performance for the first three months of 2013.

In the first three months of 2013, revenue increased by 13% to EUR 0.7 m (Q1 2012: EUR 0.6 m). This includes significantly growing royalties from Veregen®, which increased by 48% to EUR 0.6 m (Q1 2012: EUR 0.4 m). Total revenue amounted to EUR 1.3 m compared to EUR 1.6 m in the first quarter of 2012, when Medigene received a one-time compensation payment of EUR 0.4 m. Disregarding this one-time effect in the previous year's first quarter, total revenue in the reporting period increased by 6%.

With constant operating costs of EUR 3.6 m (Q1 2012: EUR 3.6 m), Medigene generated EBITDA of EUR -2.3 m in the first three months of 2013 (Q1 2012: EUR -2.1 m). Disregarding the one-time compensation payment effect, the loss on an EBITDA basis was reduced by 6% compared to the previous year's first quarter.

In the first three months of 2013, Medigene reported a net result of EUR -3.3 m (Q1 2012: EUR -0.1 m). The increased loss versus the previous year's first quarter is a consequence of the above-mentioned one-time compensation effect, as well as a revaluation of an investment of EUR 2.2 m which was posted for the first quarter of 2012.

As of 31 March 2013, Medigene's cash and cash equivalents totaled EUR 16.7 m. Medigene expects cash reach to be secured at least until the end of 2014.

Business updates since the beginning of 2013

Veregen®:

  • Inclusion of Veregen® into the European Guideline for the Management of Anogenital Warts
  • Market launch in Serbia
  • Market approval in the Czech Republic
  • Partnership agreements for the commercialization of Veregen® in Asia, Australia, and New Zealand

EndoTAG®-1:

Completion of the investigator-initiated trial (IIT) of EndoTAG®-1 in triple negative breast cancer (TNBC). The results will be published during the Annual Meeting of the American Society of Clinical Oncology (ASCO) on 15 May 2013 (6 p.m. EDT).

RhuDex®:

Clinical trial plan expanded for the development of RhuDex® in primary biliary cirrhosis (PBC)  

AAVLP:  

Initial preclinical data on successful protection against several major HPV virus subtypes

Peter Llewellyn-Davies, Chief Financial Officer of Medigene AG comments: "Our company's quarterly financial results and operational development are in line with our expectations and demonstrate a positive trend. The upcoming market launch of Veregen® in a number of additional countries will stimulate Medigene's sales growth. At the same time, we are preparing a phase II clinical trial of RhuDex® and are seeking a further partner for the planned phase III clinical trial of EndoTAG®-1. We continue to drive the implementation of our goals."

Outlook

Medigene confirms its operational and financial guidance for 2013 that was provided on the occasion of the annual report 2012 at the end of March 2013. The company expects increasing total revenue to about EUR 7 - 8 m and an EBITDA-loss between EUR 9 - 11 m.

Consolidated income statement (abbreviated)

 

 

 

 

 

In EUR k Q1 2013
unaudited
Q1 2012
unaudited
Change
Revenue 680 604 13%
thereof Veregen® royalties 558 377 48%
thereof Veregen® revenue from supply chain 70 225 -69%
thereof Veregen® milestone payments 52 2 >200%
Other operating income 629 1,018 -38%
thereof one-time effect (compensation payment) 0 390 -
Total revenue 1,309 1,622 -19%
Cost of sales -223 -278 -20%
Gross profit 1,086 1,344 -19%
Operating expenses -3,574 -3,601 -1%
thereof selling, general and administrative expenses -1,821 -1,761 3%
thereof research and development expenses -1,753 -1,840 -5%
Operating result -2,488 -2,257 10%
Income from revaluation of an investment 0 2,154 -
Net result for the period -3,273 -124 >200%

 

 

 

 

 

 

 

Detailed financial results:

Revenue and other operating income

In the first three months of 2013, revenue increased by 13% to EUR 680 k (Q1 2012: EUR 604 k). This includes significantly growing royalties from Veregen® which increased by 48% to EUR 558 k (Q1 2012: EUR 377 k), as well as milestone payments from partners totalling EUR 52 k (Q1 2012: EUR 2 k). Revenue from the supply of Veregen® to marketing partners decreased to EUR 70 k (Q1 2012: EUR 225 k), due to the partners' fully stocked warehouses. In-market sales of Veregen® achieved through our partners increased by 47% to EUR 3.5 m.

In addition, Medigene generated other operating income totalling EUR 629 k (Q1 2012: EUR 1,018 k). This mainly consisted of the future cash flows of EUR 208 k per month from the 2% royalty share on Eligard® net sales monetized with Cowen in 2012. This revenue is a non-cash item. In the first quarter of 2012, Medigene also received a one-time payment of EUR 390 k from a service provider as compensation for costs incurred.

Due to this one-time compensation effect, total revenue in the first three months of 2013 decreased to EUR 1,309 k (Q1 2012: EUR 1,622 k). Disregarding this one-time effect, total revenue increased by 6% from EUR 1,232 k (Q1 2012) to EUR 1,309 k (Q1 2013).

Selling, general and administrative expenses

Compared to the previous year's reporting period, selling, general and administrative expenses increased from EUR 1,761 k (Q1 2012) to EUR 1,821 k (Q1 2013). This amount includes selling expenses of EUR 616 k (Q1 2012: EUR 541 k) and general and administrative expenses of EUR 1,205 k (Q1 2012: EUR 1,220 k). The increased selling expenses were due to the commercialization of Veregen®.

Research and development expenses

Research and development expenses decreased to EUR 1,753 k in the first three months of 2013 (Q1 2012: EUR 1,840 k). This decrease is primarily the result of reduced expenses for clinical trials, since a clinical trial of RhuDex® was completed in mid-2012. The expenses for preclinical development, particularly the preparation for further clinical trials, however, increased.

EBITDA

Medigene's EBITDA is derived from the result for the period excluding taxes, financial result, result from investment in an associate, income from revaluation of an investment, and depreciation and amortisation. The result on an EBITDA basis totaled EUR -2,296 k in the first three months of 2013 (Q1 2012: EUR -2,050 k). Disregarding the one-time effect in other operating income, the loss on an EBITDA basis was reduced by 6% from EUR 2,440 k (Q1 2012) to EUR 2,296 k (Q1 2013).

Income from revaluation of an investment

Since the beginning of 2012, Immunocore Ltd. is no longer recognised as an associate. As a consequence of the reduction of the share in Immunocore Ltd. to below 20%, this investment was reclassified in the balance sheet and, accordingly, a revaluation pursuant to IAS 28.18 at fair value was carried out. The revaluation associated with it resulted in a non-cash income of EUR 2,154 k for the first three months of 2012. The reclassification was implemented as part of the audit of the annual financial statements, and the previous year's figures have now been adjusted accordingly.

3-months result 2013

In the first three months of 2013, a net result of EUR -3,273 k (Q1 2012: EUR -124 k) was achieved. The previous year's result was positively influenced by the above-mentioned one-time effects (revaluation of an investment and compensation payment by service provider).

Cash used by operating activities

Net cash used by operating activities amounted to EUR -3,400 k in the first quarter of 2013 (Q1 2012: EUR -2,531 k). Hence, the average monthly net cash usage was EUR -1.1 m (Q1 2012: EUR -0.8 m). Most of the cash used by operating activities consists of research and development as well as selling, general, and administrative expenses. The increase in the first three months of 2013 is mainly due to an increase in inventories.

Press and analysts' conference call:
A press and analysts conference call (in English) will be held today at 11:00 a.m. CEST and will be webcast live. Please access the synchronized presentation slides and a recording via Medigene's website, www.medigene.com.

The detailed Quarterly Report is available at www.medigene.com/reports

Medigene AG is a publicly listed (Frankfurt: MDG, prime standard) biotechnology company headquartered near Munich, Germany. Medigene focuses on clinical research and development of novel drugs against cancer and autoimmune diseases. Medigene is the first German biotech company to have revenues from marketed products, which are distributed by partner companies. It has two drug candidates in clinical trials, EndoTAG®-1 and RhuDex®; and is developing an innovative vaccine technology.

This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene®, EndoTAG®, RhuDex® and Veregen® are registered trademarks of Medigene AG. Eligard® is a trademark of Tolmar Therapeutics, Inc. Polyphenon E® is a trademark of Mitsui Norin Co., Ltd. These trademarks may be owned or licensed in select locations only.

Contact Medigene AG
Julia Hofmann, Claudia Burmester
Investor & Public Relations
Tel.: +49 - 89 - 20 00 33 - 33 01
Email: investor@medigene.com

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