Main Subject - Business

One of the most difficult sections to write in a business plan is the proforma and financial sections. After all it is most difficult to what exact costs you will incur or what level of sales volumes are actually achievable. So often businesses are faced w

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

ith excess government controls at all levels which take thousands of dollars in fees, additionally legal fees, delays and lawsuits often ensue and slow the project. You cannot know in advance what roadblocks or brick walls city planners, country agencies o

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

Examples of combination products may in

Federal Regulators will come up with, as they often change their minds and add new laws in the middle of your already delayed project. These are only a few of the problems facing entrepreneurs when writing financial projections. Other issues occur from an

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

over enthusiastic entrepreneurial positive attitude and business plan writers should double the money needed and triple the time to complete the project to be on a reality based plain. Thus if you beat your projections everyone is happy. Including bankers,

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

investors and yourself. If folks are not happy you may find yourself in court defending yourself and making excuses, many of which many not be your fault, but in the end you are hung out to dry as the buck stops with you.

To assist you in writing your fin

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

Combination pro

ancial projections section of your business plan, I have prepared a sample. This sample is from a most simple business model; a mobile car wash, which is part of a franchise system. Please feel free to print this article out and make notes in the margins a

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

d then take a legal pad and sketch out your own financial projections and start-up capital needed. I sincerely hope this sample helps you.

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Financial Projections

We will follow our business plan to keep us in a profitable

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

ituation at all times. We will try to keep our car wash truck busy at all times. We will stay on top of collections and make sure all invoices go out on time and are directed to the person who authorizes payment. We will treat cash flow as a primary obj

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

ctive in order to reach our financial projections. We will be sure to have the right mix of services.

Gross Revenue Percentage Breakdown

Personal Car Washing 60%
Graffiti, Industrial, Concrete 20%
Fleet Washing 15%
Other 5%

Gross Revenue

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

:

Insert Graph or Pie Chart Here.

* Note: Car washing of personal vehicles will be 60% of our business. Over 80% of these monies will be collected at the point of sale by either:

· Cash
· Check
· Credit Card

Some will actually be paid in ad

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

ance on credit cards thus keeping us on the proper course to achieve positive cash flow at all times. Very few customers will be allowed to be billed monthly.

** Note: Fleet washing and industrial (graffiti, concrete, etc.) will only account for 35% of

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

Following aspects would a

ross receipts. Twenty-five percent of this will be collected at the time the work is done, leaving only 26.25% of gross receipts to be billed at month’s end.

Billing

On fleet accounts, all invoices will be net due in fifteen days. After fifteen days th

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

y will be considered late and 2% will be charged. If, in the future, our mix of percentages of services performed changes, we may offer a 2% discount for payment in ten days and a 1% discount for payment between ten and fifteen days. We don’t anticipate

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

changing our mix. However, if our city awards us a graffiti contract for $75,000 a year we will definitely accept it.

Anticipated Gross Sales From Services

In the appendix there is a first year pro forma of projected sales. We believe these figures are

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

attainable. For various reasons we will take a 70% scenario for budgeting purposes in case everything doesn’t go as planned. Just to be on the safe side. We project a conservative gross sales dollar amount to be:

$124,630 Projected Gross Revenue X .70

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

70% Of Projected Dollars = $ 87,241 A Conservative Safe Number To Project As First Year Gross Receipts

Anticipated Business Expenses

We project costs of $56,112 for our first year of expenses. Please see spreadsheet in the appendix. We will add in a

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

Professional from academic institutions, pharmaceutical industries, health care indust

20% fudge factor just in case we have any unanticipated expenses in year one. We project a conservative business expense dollar amount to be:

$56,112 Anticipated Expenses X .20 20% Fudge Factor = $11,222 Possible Additional And Unanticipated Expens

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

es During Year One

$56,111 Anticipated Expenses +11,111 Unanticipated Expenses = $67,334 Total Anticipated And Unanticipated Business Expenses For Year One.

Profit Per Truck

Please see the graph on the following page of the “Net Profit One Truck”. T

.

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

is graph is based on the spreadsheets “Anticipated Gross Sales From Services” minus “Anticipated Business Expenses”.

We realize that if a conservative approach is taken, we must use the 70% scenario for Gross Sales and add 20% to Business Expenses. We pr

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

Companies that provide selfless information through particip

ject a conservative net profit for the first truck in year one to be:

$ 87,241 Gross Receipts - 67,334 Expenses = $ 19,907 First Year Profit. $ 19,907 First Year Profit divided by 12 Number Of Months = $ 1,659 Per Month Profit, A Good Conservative Number

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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This strategic approach works in any size business and cuts advertising clutter to shreds, resulting in increased margins and staff retention, reduced customer attrition, radically decreased cost of sales and risk and exponential growth.

If your anything like me, you would have tried so many different paths and always end back at the starting blocks! I'm happy to say I have found a solution for myself to get out of the rut in deciding which career path to take. I hope my story helps just one other person in setting goals and using their imagination in finding something they are passionate about in life!

That leap from being paid by others to relying on your own business for an income is a frightening one. Make sure you are going about it the right way.

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