SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(D) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date of
Report (Date of earliest event reported): April 11, 2008
PDI,
INC.
(Exact
name of Registrant as specified in its charter)
|
DELAWARE
|
0-24249
|
22-2919486
|
|
(State
or other jurisdiction of incorporation)
|
(Commission
File Number)
|
(IRS
Employer Identification No.)
|
Saddle
River Executive Centre
1 Route
17 South,
Saddle
River, NJ 07458
(Address
of principal executive offices and zip Code)
(201)
258-8450
Registrant's
telephone number, including area code:
(Former
name or former address, if changed since last report)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
¨ Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
¨ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item 8.01 Other
Events.
On April
11, 2008, PDI, Inc. (the “Company”) issued a press release announcing the
signing of a Promotion Agreement (the “Agreement”) with Novartis Pharmaceuticals
Corporation (“Novartis”). A copy of the press release is attached as
Exhibit 99.1 hereto and is incorporated herein by reference.
Background
The
Agreement is the first arrangement entered into by the Company under its
previously announced Product Commercialization strategic
initiative. While these product commercialization initiatives involve
significantly more risk than the Company’s typical fee for service contracts
with respect to a return on the Company’s investment and are likely to result in
losses for the Company during the early stages of the initiative as program ramp
up occurs, these opportunities are intended to provide the Company with the
ability to extend its revenue streams through multi-year arrangements and with
greater profit margins than its typical fee for service arrangements over the
term of the contract.
The
Agreement
Pursuant
to the Agreement, the Company has the co-exclusive right to promote on behalf of
Novartis the pharmaceutical product Elidel® (pimecrolimus) Cream 1% (the
“Product”) to physicians in the United States. Under the Agreement,
Novartis retains all other rights in and to the Product, including
manufacturing, regulatory, medical, clinical development, pricing, managed care
contracting and distribution responsibilities. Novartis also retains
the right to co-market and co-promote the Product during the term. In
connection with the Agreement, the Company currently intends, at its own cost
and expense, to utilize an initial sales force of approximately 100 full time
equivalent pharmaceutical sales representatives to promote the Product to
physicians. The Company must perform a minimum number of sales calls
to designated physicians each year, and the failure to satisfy this requirement
could result in penalties for the Company or provide Novartis with the ability
to terminate the Agreement for the Company’s failure to perform. The
Company currently intends to perform significantly more than the minimum number
of sales calls during the initial 12 months of the Agreement. In
addition to its sales force activities, the Company is obligated under the
Agreement to spend at least $7.0 million per year during the term on promotional
activities relating to the Product, which will include the Company’s purchase of
Product samples from Novartis to provide to the Company’s sales force in
connection with its sales calls to physicians. In connection with
this Agreement, the Company currently intends to make expenditures of
approximately $20 to $21 million during the initial 12 months of the Agreement
in connection with its sales force activities and the promotion of the Product,
which includes the $7 million minimum spend requirement described
above.
In
consideration of the rights granted to the Company under the Agreement, the
Company will make a $1.0 million upfront payment to Novartis. In
exchange for its promotional activities, the Company will be compensated each
quarter based on a specified formula set forth in the Agreement relating to
Product sales for the quarter. It is possible that the Company may
not receive any compensation if Product sales are below certain thresholds set
forth in the Agreement. In addition, if the Agreement is not
terminated prior to its scheduled expiration on March 31, 2012, if due under the
terms of the Agreement, Novartis will provide the Company with two residual
payments in accordance with specified formulas set forth in the Agreement, which
are payable 12 and 24 months after the expiration of the term of the
Agreement. The Agreement provides that if one or more major market
events occur during the term that significantly affect the Product, in certain
cases either party will have the right to terminate the Agreement.
The term
of the Agreement is approximately four years, extending through March 31, 2012,
and it may be extended for an additional year upon the mutual agreement of the
parties. However, either party may terminate the Agreement if the
other party materially breaches or fails to perform its obligations under the
Agreement. In addition, either party may terminate the Agreement,
effective no earlier than February 2010, upon three months prior notice to the
other party if the number of prescriptions for the Product generated in a
specified period is less than a predetermined level for that
period. Novartis may terminate the Agreement, effective no earlier
than January 2010, without cause upon three months prior notice to the Company
subject to the payment of an early termination fee based in part on a fixed
amount and in part on a specified formula set forth in the
Agreement.
Due to
the Company’s significant investment of its sales force and other promotional
resources under this Agreement and the Company’s expectation that a ramp up
period will be necessary before any meaningful increase in Product prescriptions
can be attained, any early termination of the Agreement will likely result in
significantly less revenue for the Company under the Agreement than currently
anticipated or could result in a net loss.
About Elidel (pimecrolimus)
Cream 1%
ELIDEL®
(pimecrolimus) Cream 1% is indicated as second-line therapy for the
short-term and non-continuous chronic treatment of mild to moderate atopic
dermatitis in non-immunocompromised adults and children 2 years of age and
older, who have failed to respond adequately to other topical prescription
treatments, or when those treatments are not advisable. ELIDEL Cream
is not indicated for use in children less than 2 years of age.
Forward-Looking
Statements
This Form
8-K contains forward-looking statements regarding future events and financial
performance. These statements are based on current expectations and assumptions
involving judgments about, among other things, future economic, competitive and
market conditions and future business decisions, all of which are difficult or
impossible to predict accurately and many of which are beyond the Company’s
control. These statements also involve known and unknown risks,
uncertainties and other factors that may cause the Company’s actual results to
be materially different from those expressed or implied by any forward-looking
statement. Such factors include, but are not limited to: changes in
outsourcing trends or a reduction in promotional, marketing and sales
expenditures in the pharmaceutical, biotechnology and life sciences industries;
the loss of one or more significant clients or a material reduction in service
revenues from such clients; the ability to fund and successfully implement the
Company’s long-term strategic plan; the ability to successfully develop product
commercialization opportunities; the ability to successfully identify, complete
and integrate any future acquisitions and the effects of any such acquisitions
on the Company’s ongoing business; the ability to meet performance goals in
incentive-based and revenue sharing arrangements with clients; competition in
our industry; the ability to attract and retain qualified sales representatives
and other key employees and management personnel; product liability claims
against the Company; changes in laws and healthcare regulations applicable to
the Company’s industry or the Company’s, or its clients’, failure to comply with
such laws and regulations; volatility of the Company’s stock price and
fluctuations in its quarterly revenues and earnings; potential liabilities
associated with insurance claims; failure of, or significant interruption to,
the operation of its information technology and communications systems; and the
risk factors detailed from time to time in the Company's periodic filings with
the Securities and Exchange Commission, including without limitation, the
Company's Annual Report on Form 10-K for the year ended December 31, 2007, and
the Company's subsequently filed quarterly reports on Form 10-Q and current
reports on Form 8-K. Because of these and other risks, uncertainties and
assumptions, undue reliance should not be placed on these forward-looking
statements. In addition, these statements speak only as of the date of this Form
8-K and, except as may be required by law, the Company undertakes no obligation
to revise or update publicly any forward-looking statements for any
reason.
Item
9.01 Financial Statements and Exhibits.
(c) Exhibits
|
99.1
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Press
Release dated April 11, 2008.
|
* * * * *
* *
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant
has duly caused this report to be signed on its behalf by the
undersigned
hereunto duly authorized.
PDI,
INC.
------------------------------------
Michael
J. Marquard
Chief
Executive Officer
Date:
April 11, 2008
EXHIBIT
INDEX
Exhibit
No. Description
___________ ____________
99.1 Press
Release dated April 11, 2008
EXHIBIT
99.1