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    There are hundreds of thousands of business plans floating around and attempting to find a funding home. I receive hundreds of business plans annually myself, and can definitely state that 99% of these documents are laughable as presentations of an exciting investment opportunity. I am not referring to the value of the product being described, rather the presentation that purpor
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    ts to describe an exciting investment situation.

    One of the reasons that so many plans are so poorly written, and there are many, many additional reasons, is that the writers do not understand how plans are read. Investment banks, venture capital firms, family offices, angel firms, banks and blind investment pools receive a stack of plans for consideration every day. Typically
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    a junior reader, often a recent MBA, is assigned to read and screen the plans editing out all of the obvious losers. The remaining business plans are then marked up after sections are read in the following order: Executive Summary, Financials, Management, and Exit Strategy.

    Why is the order in which a business plan is read important to recognize? Because, these are the areas th
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    at must be powerfully and compellingly addressed in order to have the business plan placed in front of decision- makers. The writing and construction of these sections dictate the level of interest that the original screening reader will express in the synopsis they will attach to the business plan copy as it begins it’s route through the project analysis process.

    The Executive
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    Summary is read first. This should be a two page vivid snap shot of the enterprise, and touch on each aspect of the opportunity. The Executive Summary needs to paint an exciting word picture that leaves the reader wanting to know more. Unfortunately, most plans are not read beyond the first paragraph or two.

    Why? I have discussed this with investors on many occasions. I have a
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    sked the question, “aren’t you worried that you might be missing out on a great product opportunity just because the document has a weakly written Executive Summary”? The universal answer, “if there is no more passion or ability to excite us than we see in a poor Executive Summary, we have never had to look back at a missed opportunity. If you can’t make a great first impression
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    for us, you won’t for anybody else either”?

    You only get one chance to make a great first impression. The business plan is your projects first impression. It is the superstructure of your opportunity, the skeleton, and a foundation. If a house has a weak foundation it will not stand up for long. Why entrepreneurs submit documents that do not properly reflect the excitement the
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    y believe inherent in their invention is a sad mystery. A poorly executed Executive Summary negates all of the time, energy, investment and innovation built into a new offering.

    Assuming the newly submitted Business Plan has an exemplary Executive Summary, and passes the initial screening read, Financials are read next. Why Financials? Well, the Executive Summary is the skelet
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    on of a project, while the Financials are the muscle.

    Financials are based on a set of assumptions that are key to presenting a realistic, justifiable cash flow, balance sheet and income statement. Investors have certain Return on Investment parameters that they must seek to achieve before they can consider any investment commitment. The assumptions upon which the Financials ar
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    e based must be from thorough research, current market conditions and historical means.

    The principal reason Financials lead to project death is that the assumptions are based on dreams, hope and pie in the sky. A rule of thumb for successfully leaping the Financials section hurdle is this: investors need to realistically see that they will receive a mid-30’s per cent return on
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    investment commencing between month 24 and 36 (year 3) after an investment is made. This rate and speed of return must be able to stand aggressive scrutiny. Believe me, investors are manic about analyzing, poking, prodding and tearing apart the assumptions upon which the Financials are constructed.

    Good News! Your Business Plan has successfully passed through the Executive Sum
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    mary and Financials doors. Next up, Management!

    The Management section represents the brains of the new enterprise being considered for investment. An experienced (industry specific) management team must be either on hand, or readily available for successful placement. The downfall in this area for so many prospective entrepreneurs is a complete lack of direct management exper
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ience. I recently reviewed a terrific safety product that had immense appeal. An exciting product, great margins, consumer need and obvious benefits, however, the group seeking funding had no executive management experience in any area the project required. They are candidates for a sale or license, but no funding round ever occurs without strong management. Remember: the invest
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ment is being made in people, people capable of driving an exciting opportunity to success.

    Do not dream about running your own company, with someone else’s money, if you are a warehouse manager by trade but need production and marketing experience to succeed at the new business. It just will not happen, unless the investment comes from Aunt Hazel.

    However, if you have strong
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    and direct management experience and the Management section indicates a rounded team, the plan will move on through door three and to the last initial barrier to be overcome. What is your Harvest Goal (exit strategy)?

    The Exit Strategy is crucial for investors and the effective management of their money pools. The Exit Strategy is the brain, intellect and emotional component of
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    the deal. Venture capital is a high risk/high reward game. Investors know that the successful investment must pay out large, and relatively quickly, in order for them to cover the losers that greatly outnumber the home runs they hit.

    Some entrepreneurs are unrealistic about harvesting gains from their business. This scares investment and venture money. An agreed plan to depart
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    , take profits, sell or exercise myriad other harvest mechanisms at maximized points in the business cycle will be demanded before investment will be considered. It is best for the entrepreneur to be highly flexible when negotiating the harvest. The Exit Strategy is best summarized as an area where the entrepreneur is open, flexible, wishing to maximize profits and make a deal f
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    air to all parties.

    Inflexibility is a mortal sin for those seeking investment. I can not overstate how many deals never happen, products linger and die, opportunities are lost because an owner is unrealistic in framing his requirements for his enrichment when potential success is achieved. Leave something on the plate for all parties in a deal.

    The other sections of a customi
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    zed business plan are now important, but only after the pre-eminent Executive Summary, Financials, Management and Exit Strategy areas have passed muster. If your business plan has all four in good order you will be in rare company. Too many entrepreneurs dream about securing investment. This is anything but a dreamy exercise. It is tough, competitive, demanding, hard work. If yo
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    u put the necessary effort into your project you will greatly enhance your chance for success!

    Do not take shortcuts! Do not guess at details and assumptions! Do not fill in the blanks on a store bought template! Do not offer your opportunity for review until you have a professional, exciting presentation! Your Business Plan represents you, your family and your partner’s future


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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