Paradigm raised its target to $ 2.00
posted on
Dec 21, 2009 10:05PM
Commercialization of protein-based vaccines & biopharmaceuticals
Paradigm Capital Inc, IIROC/TSX member 1
Claude Camiré, Analyst 416.360.1322 December 21, 2009 Financial Summary (C$) (end-Dec) Rev EPS EV/Rev (x) P/E FY08 2.2 (0.17) 63.6 NA FY09e 1.0 (0.07) 140 NA FY10e 3.0 (0.08) 46.7 NA FY11e 75.4 0.13 1.9 3.9 All figures in C$ unless otherwise noted ?? Positive Phase 1 clinical trial for H5N1 (avian flu) vaccine. No
other novel technologies have ever achieved these clinical results. ?? Medicago will take advantage of these results to add new
commercial contracts. ?? Buy rating maintained and target price increased from $1.50 to
$2.00. Positive Phase 1 Clinical Trial Medicago Inc. announced very promising clinical results for the first Phase 1 study for its H5N1 (avian flu) pandemic vaccine candidate. The clinical trial included 48 healthy volunteers between the ages 18-60, who received two doses of either Medicago’s vaccine at doses of 5, 10 or 20 micrograms (mcg) or a placebo. No serious adverse effects were reported during the trial and the vaccine was found to be well tolerated at all three dose levels. This trial was the first ever clinical evaluation of a plant-based VLP (Virus-Like Particles) vaccine showing Medicago’s vaccine is safe in humans. Strong Immune Response Medicago also reported strong preliminary immune response with 81% of subjects developing an immune response against the H5N1 virus after the second immunization. A four-fold increase in HI titers (rate of sero-conversion) from baseline in 58% of subjects was observed in the 20 mcg group. These numbers were among the best results we have seen for vaccines at this low dose. HI titers greater than 1:40 were developed in 50% of subjects in the 20 mcg group. More importantly, Medicago indicated the vaccine demonstrated cross protection against two other strains of H5N1 avian influenza. Seasonal and pandemic influenza events usually have strains that mutate. For years, scientists with egg/cell-based vaccines have tried without success to develop a broader vaccine applicable to multiple strains. Results at these lower dosage levels have not been reported for an H5N1 avian vaccine manufactured with a novel manufacturing technology. Stock Rating: Buy 12- target (C$) ?? 2.00
Potential ROR 156% Company Profile Sector Health Care Ticker MDG-V Shares O/S (m) 181 Free float (m) 178 Mkt cap (C$m) 141 Key Metrics Enterprise Value (C$) 140 Research Team Claude Camiré Analyst 416.360.1322 Sales Toronto 416.361.1064 Calgary 877.513.1025 Paradigm Capital research is available on First Call, Reuters or at www.paradigmcap.com Refer to last page for official disclaimer Issued by Paradigm Capital Inc. 1-Year Stock Chart 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 18-Dec-08 18-Jan-09 18-Feb-09 18-Mar-09 18-Apr-09 18-May-09 18-Jun-09 18-Jul-09 18-Aug-09 18-Sep-09 18-Oct-09 18-Nov-09 18-Dec-09 C$ 12/21/09 Target raised ($2.00) 10/14/09 Initiating coverage ($1.50) Source: Bloomberg Medicago Inc. (MDG – V $ 0.78) Giant Step Forward for Vaccines Paradigm Capital Inc, IIROC/TSX member 2 Claude Camiré, Analyst 416.360.1322 December 21, 2009 Benefits of Success Medicago is now able to proceed with the three commercial partnerships that were contingent on the success of this clinical trial. Agreements with Genopole in France, Ajanta Pharma in India and Tabuk Pharma in Saudi Arabia should now proceed, leading to the construction of Proficia-based vaccine facilities. Financial details need to be finalized with partners in India and Saudi Arabia. We believe a number of countries could follow on the same path, especially those with no vaccine production facilities in their territories. Medicago also becomes eligible to receive funding for the development of new technologies from US government agencies such as HHS and NHI. In the last five years, more than US$2b has been awarded to accelerate better production methods to ensure a quick response in the event of pandemic flu. Promising Year Ahead Medicago expects to unveil the full results in the first part of 2010 in a scientific journal. The phase 2 clinical trial is now expected to commence during the first half of 2010. In Europe and the US, clinical development remains a process that can quickly change, especially if pandemic vaccines are needed. In 2009, the FDA fasttracked any drugs, vaccines or technologies that would reduce the number of deaths related to the H1N1 influenza. In Europe, the EMEA guidelines defined a route for accelerated regulatory approval through the submission of prototype pandemic vaccine files in advance of a pandemic. A number of countries have harmonized approval procedures to ensure the optimal availability of vaccines around the world. We believe Medicago would negotiate with the FDA to obtain a SPA (Special Protocol Assessment) that may award approval after one more Phase II. Currently in the US, only one other H5N1 avian vaccine has been approved (Sanofi-Aventis), based on the clinical trial results of only 500 patients. Safe, Better, Cheaper and Faster Now that the safety point has been made, Medicago is certainly going to emphasize its other key advantages compared to egg-based or cell-based technologies. For 40 years egg-based vaccines have been used to produce vaccines in limited supply because of the yield and time (6 months) required to produce a final product. Cell-based vaccines are new and have not been used greatly because they offer a small improvement in terms of cost and production speed. Plant-based vaccines present a disruptive approach and could provide a clear improvement in production time (from 6 months for egg-based vaccines to 1 month) at a reduced cost base (assumed to be 50% cheaper). Promise Beyond Vaccines The Phase 1 clinical trial results offer more than just proof of concept. Traditionally for vaccines, the biggest hurdle is to achieve safety and immune response at the lowest dose, which Medicago has now done. However, more testing is required to demonstrate safety to a wider population group, especially kids and pregnant women. These results are important because they also demonstrate that VLP (Virus-Like Particles) plant-based technologies could potentially be used to produce peptides/proteins and antibodies, a US$15-20b industry. According to the Bio Industry Organisation, more than 370 therapeutic proteins are currently in development. Traditional cell culture methods require significant capital and labour investment; cell culture facilities cost about $250-450m, and take from three to five years to build. Additionally, animal cells generally require costly and complex media to sustain the cells and the addition of growth factors and animal-based Paradigm Capital Inc, IIROC/TSX member 3 Claude Camiré, Analyst 416.360.1322 December 21, 2009 products that may themselves introduce contaminants into culture systems. Medicago holds tremendous competitive advantages in these regards. Increased Focus by Big Pharma in the Vaccine Business Substantial interest from the larger drug companies will emerge from two different angles: the need for double digit growth and interest in immunization from generics. In the last two years, new production facilities have been built by Sanofi-Aventis (SNY-N), GlaxoSmithKline (GSK-N), Baxter (BAX-N) and Novartis AG (NVS-N) to meet increasing demand. Johnson & Johnson (JNJ-N) is making a big comeback in the vaccine field and is paying €301.8 million for an 18% equity stake in Crucell NV (CRXL-Q) as part of a collaboration related to monocolonal antibodies and vaccines against influenza and other diseases. Merck has quietly arranged to be a major player with the licensing of technologies with two companies (Pfenex, Nobilon) and signed a major distribution agreement with CSL Ltd (CSL-ASX) for the US market. We believe these results provide a new stardom for Medicago in an industry that needed a dose of innovation. Taking Advantage of these Good Results We expect the vaccine industry to explode from the US$3.5b market in 2007 to more than US$10b by 2015. Perhaps even more topical, Medicago has a platform to address pandemic flu vaccines against H5N1, H1N1 and seasonal influenza that could generate sales by 2011. Global pandemic vaccine supply has fallen far short of demand, offering potential upside to our Medicago forecast. We believe the industry will benefit from external factors for years to come. Contrary to other sectors in the pharmaceutical industry, more than 80% of the cost for vaccines is reimbursed by government organizations like Medicare in the US. Government agencies in the US play a large role in the funding of new technologies for which Medicago becomes eligible with these new results. We believe Medicago’s vaccine portfolio plays perfectly in the new reality that is facing our society. The success of these trials increases our confidence in achieving a commercial product, therefore allowing us to reduce our discount rate in our NPV calculations. We are increasing our target price from $1.50 to $2.00 and maintaining our Buy recommendation. Paradigm Capital Inc, IIROC/TSX member 4 Claude Camiré, Analyst 416.360.1322 December 21, 2009 Income Statement C$m Medicago Income Statement (FYE: Dec 31) 2008 2009e 2010e 2011e 2012e 2013e 2014e 2015e Revenues H5N1 0.0 0.0 0.0 27.2 57.9 121.0 184.6 220.8 H1N1 0.0 0.0 0.0 0.0 21.4 107.5 154.6 204.2 Seasonal Flu 0.0 0.0 0.0 45.2 93.2 179.6 232.4 252.7 Other 2.2 1.0 3.0 3.0 3.0 3.0 3.0 3.0 Total 2.2 1.0 3.0 75.4 175.5 411.2 574.6 680.7 Cost of product sales 0.0 0.0 0.0 18.0 43.3 93.2 131.0 153.1 Gross Margin 2.2 1.0 3.0 57.3 132.3 317.9 443.6 527.7 % Revenues 99% 100% 100% 76% 75% 77% 77% 78% Operating Expenses Research and development 3.7 6.5 12.0 25.0 30.0 40.0 50.0 60.0 General and administrative 3.3 4.0 5.0 6.0 7.0 9.0 10.0 11.0 Total Operating Expenses 7.0 10.5 17.0 31.0 37.0 49.0 60.0 71.0 EBITDA (4.8) (9.5) (14.0) 26.3 95.3 268.9 383.6 456.7 % Revenues -219% -950% -467% 35% 54% 65% 67% 67% Depreciation and amortization (0.6) (0.6) (0.6) (0.6) (0.6) (0.6) (0.6) (0.6) Interest expenses (1.7) (1.0) (1.0) (1.0) (1.0) (1.0) (1.0) (1.0) FX and OTC (0.6) (0.5) Taxes 0.0 0.0 0.0 0.0 (19.1) (94.1) (134.3) (159.8) Net earnings (loss) (7.7) (10.4) (14.4) 25.9 75.8 174.4 248.9 296.4 EPS Basic ( Fully diluted ( Shares outstanding Basic 45.0 97.0 125.0 150.0 150.0 150.0 150.0 150.0 Fully diluted 45.0 157.0 181.0 200.0 200.0 200.0 200.0 200.0 C$m Source: Company, Paradigm Capital Paradigm Capital Inc, IIROC/TSX member 5 Claude Camiré, Analyst 416.360.1322 December 21, 2009 Disclaimer Section 1. Claude Camiré does not have an ownership position in Medicago Inc (MDG-V) 2. Paradigm Capital Inc. has assumed an underwriting liability for, and/or provided financial advice for consideration to Medicago Inc (MDG-V) during the past 12 months. 3. Paradigm’s disclosure policies and research distribution procedures can be found on our website at www.paradigmcap.com. Research Rating System Paradigm Capital uses the following rating recommendations in its research: Speculative Buy – Expected returns of 10% or more over the next 6-12 months on high-risk development or “pre-revenue” companies, such as junior mining and early stage biotech companies. (15% of Paradigm’s coverage list consists of Speculative Buy recommendations). Buy – Expected returns of 10% or more over the next 6-12 months. (64% of Paradigm’s coverage list consists of Buy recommendations). Hold – Expected returns of +/-10% over the next 6-12 months. (18% of Paradigm’s coverage list consists of Hold recommendations). Sell – Expected returns of –10% or more over the next 6-12 months. (2% of Paradigm’s coverage list consists of Sell recommendations). About Paradigm Capital Inc. Paradigm Capital is a research-driven, independent, institutional equity investment dealer focused on sectors and companies that have attractive long-term secular growth prospects. Paradigm Capital’s research is available on our website at www.paradigmcap.com. Please speak to your Sales or Trading Representative if you require access to the website The analyst (and associate) certify that the view expressed in this report accurately reflect their personal views about the subject securities or issuers; No part of their compensation was, is, or will be directly or indirectly, related to specific recommendations expressed in this research report. Analysts are compensated through a combined base salary and bonus payout system. The bonus payout is determined by revenues generated directly or indirectly from various departments including Investment Banking, based on a system that includes the following criteria: reports generated, timeliness, performance of recommendations, knowledge of industry, quality of research and investment guidance and client feedback. Analysts are not directly compensated for specific Investment Banking transactions. The opinions, estimates and projections contained herein are those of Paradigm Capital Inc. (“PCI”) as of the date hereof and are subject to change without notice. PCI makes every effort to ensure that the contents herein have been compiled or derived from sources believed reliable and contain information and opinions, which are accurate and complete. However, PCI makes no representation or warranty, express or implied, in respect thereof, takes no responsibility for any loss arising from any use of, or reliance on, this research report or its contents. Information may be available to PCI, which is not reflected herein. This research report is not to be construed as an offer to sell, or solicitation for or an offer to buy, any securities. PCI, its affiliates and/or their respective officers, directors or employees may from time to time acquire, hold or sell securities mentioned herein as principal or agent. PCI may act as financial advisor and/or underwrites for certain of the corporations mentioned herein and may receive remuneration for same. Paradigm Capital Inc. is a member of The Toronto Stock Exchange, The TSX Venture Exchange and The Investment Industry Regulatory Organization of Canada (IIROC). Any products or services mentioned on this website are made available only in accordance with local law (including applicable securities laws) and only where they may be lawfully offered for sale. Paradigm Capital Inc. will not open accounts except in jurisdictions in which it is registered. To U.S. Residents: This report was prepared by Paradigm Capital Inc. which is not subject to the U.S. rules with regard to the preparation of research reports and the independence of analysts. Paradigm Capital U.S. Inc, affiliate of PCI, accepts responsibility for the contents herein, subject to the terms as set out above. Any U.S. person wishing to effect transactions in any security discussed herein should do so through Paradigm Capital U.S. Inc.
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