Medicago Announces 2013 Second Quarter Financial Results

QUEBEC CITY, Aug. 9, 2013 /PRNewswire/ - Medicago Inc. (TSX: MDG), a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced its operational and financial results for the second quarter ended June 30, 2013. The Company's financial statements and management report are available at www.sedar.com and at www.medicago.com.

Financial Results

For the three and six-month period ended June 30, 2013, the Company had revenues of $918,000 and $1,337,000, generated from the Master Research Collaboration Agreement with Mitsubishi Tanabe Pharma Corporation ("MTPC") for the development of a first product, a Rotavirus Like Particle (RLP) vaccine target; a joint research agreement with TRIA Bioscience Corporation as part of the license agreement signed by Medicago with Immune Design under which Immune Design has granted Medicago a worldwide, non-exclusive licence to research, develop and commercialize GLA as a component of its VLP-based vaccines in the field of pandemic influenza, and the successful completion of Medicago's research collaboration agreement with a top 10 global pharmaceutical Corporation.

Net loss for the three and six-month period ended June 30, 2013, was $9,073,000 or $0.04 per basic and diluted share and $17,789,000 or $0.07 per basic and diluted share, compared to a net loss of $8,099,000 or $0.04 per basic and diluted share and $17,087,000 or $0.07 per basic and diluted share for the three and six-month periods ended June 30, 2012.

Cash and short-term investments were $8.9 million as at June 30, 2013, a decrease of $2.4 million from December 31, 2012.

As at August 9, 2013, there were 263,229,248 common shares issued and outstanding, 12,345,714 stock options outstanding as well as 7,163,523 warrants outstanding as at August 9, 2013 are in the aggregate of 282,738,486.

Medicago announces agreement to be acquired by Mitsubishi Tanabe Pharma Corporation

On July 12, 2013, Medicago announced that it has entered into a definitive arrangement agreement with Mitsubishi Tanabe Pharma Corporation ("Mitsubishi Tanabe Pharma" or "MTPC") whereby MTPC will acquire all of the issued and outstanding common shares ("Shares") of Medicago, other than the Shares currently held by Philip Morris Investments B.V. ("PMI") an affiliate of Philip Morris International Inc. and MTPC, for $1.16 in cash per Share (the "Purchase Price").  Upon completion of the transaction, Medicago will be jointly owned by MTPC (60%) and PMI (40%). The transaction represents a total enterprise value of approximately $357 million, including the assumption of existing indebtedness, for 100% of Medicago.

The completion of the transaction is subject to court approval pursuant to the Business Corporations Act (Québec) and the approval of Medicago's shareholders. The transaction is subject to Regulation 61-101 and the implementation of the arrangement will be subject to the approval of 66 2/3% of the votes cast by shareholders present in person or by proxy at the special meeting of shareholders of Medicago and by holders of more than 50% of the votes cast by Medicago's minority shareholders being all shareholders excluding MTPC, PMI and any of their respective affiliates. The Board of Directors of Medicago unanimously recommends that Shareholders vote in favour of the Arrangement.

The Company has mailed a management information circular to its shareholders, a copy of which can be found on Medicago's website at www.medicago.com or at www.sedar.com, for special shareholders' meeting to be held on  August 29, 2013. The transaction is also subject to customary closing conditions, including receipt of all regulatory approvals, and is expected to close by mid-September 2013. Shareholders who have any questions regarding the Arrangement or require assistance with voting may contact Medicago's proxy solicitation agent, Laurel Hill Advisory Group at 1-877-452-7184 toll free or by email at assistance@laurelhill.com.

Highlights

During the second quarter of 2013:

  • Announced positive phase I clinical results for its H5N1 vaccine in a trial run by IDRI. The vaccine was found to be safe and well-tolerated and induced a solid immune response exceeding the three CHMP (Committee for Medicinal Products for Human Use) immunogenicity criteria for licensure of influenza vaccines. The vaccine was tested in three different configurations: using IDRI's Glucopyranosyl Lipid A ("GLA") formulated adjuvant, given both intramuscularly and intradermally, and using alum intramuscularly. All three configurations exceeded the CHMP criteria.
  • Raised $3.5 million through a private placement of 6.25 million common shares.
  • Successfully produced a VLP vaccine candidate for the H7N9 virus responsible for recent influenza outbreak in China and first in the world to report positive interim preclinical results
  • Produced a plant-based Rotavirus VLP vaccine candidate comprising all four structural antigens of rotavirus (VP2, VP4, VP6 and VP7) using Medicago's plant-based manufacturing platform.
  • Was granted a patent for Influenza Virus-Like Particles in Plants
  • Received authorization from Health Canada and commenced Phase II clinical trial for an H5N1 vaccine

Outlook for the remainder of 2013

  • Closing of the transaction with MTPC, following the approval by the shareholders and receipt of all regulatory approvals, is expected to occur by mid-September 2013
  • Interim data from a Phase II H5N1 clinical trial expected in the second half of this year
  • Initiation of a US Phase II clinical trial for a quadrivalent seasonal influenza vaccine with interim data expected in the second half of this year.

About Medicago

Medicago is a clinical-stage biopharmaceutical company developing novel vaccines and therapeutic proteins to address a broad range of infectious diseases worldwide. The Company is committed to providing highly effective and competitive vaccines and therapeutic proteins based on its proprietary VLP and manufacturing technologies. Medicago is a worldwide leader in the development of VLP vaccines using a transient expression system which produces recombinant vaccine antigens in plants. This technology has potential to offer more potent vaccines with speed and cost advantages over competitive technologies, enabling the development of a vaccine for testing in approximately one month after the identification and reception of genetic sequences from a pandemic strain. This production time frame has the potential to allow vaccination of the population before the first wave of a pandemic, and supply large volumes of vaccine antigens to the world market. Medicago also intends to expand development into other areas such as biosimilars and biodefense products where the benefits of our technologies can make a significant difference. Additional information about Medicago is available at www.medicago.com.

Forward Looking Statements

This news release includes certain forward-looking statements that are based upon current expectations, which involve risks and uncertainties associated with Medicago's business and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions "anticipate", "believe", "plan", "estimate", "expect", "intend", and similar expressions to the extent they relate to Medicago or its management. The forward-looking statements are not historical facts, but reflect Medicago's current expectations regarding future results or events. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations, including the matters discussed under "Risk Factors and Uncertainties" in Medicago's Annual Information Form filed on March 28, 2013, with the regulatory authorities. Medicago assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

SOURCE Medicago Inc.




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