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You pour your time, energy and money into your business to make it a success. It's only natural to wonder how much you could sell it for. Whether you're daydreaming about retiring to an island paradise, or negotiating a complex buy/s

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

ell agreement with your partners, the question of value is an important one.

The best way to determine the value of your business is to sell it. As a matter of fact, selling it may be the only way to know for sure how much it's wort

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

. But what if you don't want to sell, or you're not sure if you want to sell? How do you determine the value of your business? The answer depends on your needs and goals.

If you're literally just daydreaming about retirement and wan

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

t to get a guesstimate of the value, chances are there is an association or trade group in your industry that has "rule of thumb" guidelines you can ask for. Typically these will be expressed as a certain multiple of sales

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

r net income. Keep in mind that these rules of thumb are notoriously unreliable, so you'll only be getting a guess that is worthless for any purpose other than satisfying your own curiosity.

You can also buy one of the many business

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

valuation software packages on the market. An internet search engine search will turn up several you could use to get a little better idea of the value of your business. You input some asset and income information into the software

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

rom your financial statements or income tax returns, and the software computes an estimated value. While this method may be better than relying on a rule of thumb, it still won't do you much good for any formal business valuation nee

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

d.

If you're fairly certain you want to sell your business, you can contact a local business broker. They typically earn their fee if and when they facilitate the sale your business, and they will often do a valuation for your for l

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ttle or no cost. They need this information in order to set an asking price. Just don't waste their time if you don't really want to sell. Many brokers won't give you a value until you list your business for sale, or they will charge

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

you for the valuation if you don't list your business with them.

For any other purpose, you are likely going to need a formal business valuation performed. There are thousands of business valuation professionals who can perform a v

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

luation for you. Ask your attorney or accountant for a referral, or check out a list of Certified Valuation Analysts in your area at www.nacva.com/dir/dir.asp.

When do b

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

siness owner's or business seekers have an appraisal done? In my practice, I find people generally want a business valuation done for one of the following reasons:

Purchase or sale of a business
Management buyouts
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
i>
Estate and gift tax
Divorce
Buy/sell agreements between partners/shareholders
Bank financing
Financial restructuring and recapitalization
Employee stock ownership plans (ESOP's)
V

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

luation of subsidiaries, divisions and joint ventures for spin-off to shareholders and/or sale

Physician buy-in to medical practices

Court appointed valuations in disputes

Minority shareholder disputes and lit

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

igation

Business damage assessment and determination

Bankruptcy

Solvency analysis and fraudulent conveyance

Mediation

Binding arbitration

As you can see, these are serious business, le

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

al and/or tax situations, and a qualified expert is needed to provide a valuation that will withstand scrutiny from attorneys, judges, juries, accountants, the IRS and knowledgeable businesspeople. As you may have guessed, such an ap

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

praisal is not going to be cheap. A typical business might spend $5,000 to $10,000 to have a business valuation performed. The more complicated your situation, the more it is likely to cost. If the valuator has to testify at depositi

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

n or in court, you will have to spend even more. While spending this kind of money is not pleasant, the cost of the appraisal is generally only a fraction of what you have at risk when you find yourself in these circumstances.

As wi

.

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

th most things in the business world, you get what you pay for when it comes to valuing your business. To get a very rough guesstimate of the fair market value of your business may cost little or nothing. To get a full valuation repo

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

t prepared by an expert who can testify in court if needed, will cost many thousands of dollars. Consult with an attorney, accountant or other professional advisor, and choose the route that makes the most sense in your circumstances

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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