Advice You - Finance

One of the keys to success at getting a consolidation loan (or any loan) from any lender is to unders

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

tand lender mentality and how lenders view borrowers and projects. First, lenders view borrowers as

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

Examples of combination products may in

ne of the following:

A Borrower - (solid income/employment, excellent credit, low d

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

bt to income ratio)

B Borrower – (employed, marginal credit rating, moderate debt t

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

o income ratio)

C Borrower - (unemployed, poor credit rating, excessive debt to inc

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

Combination pro

me ratios)

With that in mind, you have to understand that bankers are on a salary and they are going

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

to get paid whether they work with an A-Borrower or a C borrower. A-borrowers are perfect borrowers

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

who probably don’t need the loan anyway and tend to be slam-dunk deals, easy to do. C-borrowers, on

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

he other hand, are much riskier folks and require much more work to justify a loan under any conditio

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

. If you were a banker on a salary, which borrower would you rather work with?

Then, lender

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

view loan projects in one of three ways:

Green light deal - (good collate

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

Following aspects would a

ral, strong supporting income, makes economic sense)

Yellow light deal - (marginal

dd to the challenges in developing combination products:

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

collateral, marginal supporting income, marginal economic sense)

Red light deal - (

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

ittle or no collateral, insufficient income, does not make economic sense)

Pretend you are a lender,

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

would you want to work hard on a C-borrower with a red light deal? Of course not! Their loan reques

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

hits the garbage can!

Knowing how to create a professional bank package and how to communicate with

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

Professional from academic institutions, pharmaceutical industries, health care indust

lenders can move you from a C grade red/light borrower to a B grade/yellow light borrower or from a B

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

/yellow to an A/green level borrower. Bankers are lazy! By knowing the insider perspective into th

.

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

lending business people give themselves an above average chance of getting the financing they need.

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

Companies that provide selfless information through particip

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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Advice You - Things Banks & Other Lenders Won't Tell You (Part02) How Lenders View Borrowers & Projects

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