Item 1A. Risk Factors
ITEM
1A. RISK FACTORS
There
have been no material changes in the risk factors described in our Annual Report on Form 10-K for the fiscal year ended March 31, 2023, except as set forth below:
If
we are unable to establish and maintain sales and marketing capabilities or enter into agreements with third parties to market and sell
our products, we may not be successful in commercializing our products which could have a material adverse effect on our business and
financial condition.
To
achieve commercial success for an approved product through direct sales, we must establish and maintain a sales and marketing organization
or outsource sales and marketing services to third parties. There are risks involved with establishing and maintaining our own sales
and marketing capabilities and entering into arrangements with third parties to perform these services for any of our products. For example,
recruiting and training a sales force is expensive and time consuming and could delay commercialization activities. If commercialization
of a product for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we
would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost
if we cannot retain or reposition our sales and marketing personnel.
Factors
that may inhibit our efforts to successfully commercialize our products through direct sales include:
●
our
inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;
●
inability
of marketing personnel to develop effective marketing materials;
●
the
inability of sales personnel to obtain access to adequate numbers of potential customers;
●
the
lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies
with more extensive product lines;
●
the
costs associated with training sales personnel on legal compliance matters and monitoring their actions;
●
liability
for sales personnel failing to comply with the applicable legal requirements, including the prohibition on off label promotion; and,
●
unforeseen
costs and expenses associated with establishing and maintaining our own sales and marketing organization.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM
4. MINE SAFETY DISCLOSURES
Not
applicable.
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