SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 or 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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Date of report (Date of earliest event reported) December 1, 2000
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INSPIRE PHARMACEUTICALS, INC.
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(Exact Name of Registrant as Specified in Charter)
Delaware 000-31135 04-3209022
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(State or Other Jurisdiction (Commission (I.R.S. Employer
of Incorporation) File Number) Identification No.)
4222 Emperor Boulevard, Suite 470, Durham, North Carolina 27703-8466
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(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code (919) 941-9777
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(Former Name or Former Address, If Changed Since Last Report)
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Item 9. Regulation FD Disclosure.
On or about December 1, 2000 Inspire Pharmaceuticals, Inc. is sending
the following correspondence to its shareholders:
"December 2000
"Dear Shareholders:
"First, we would like to express our sincere appreciation to our many
shareholders, longstanding and new, for your support of Inspire over these past
several years. This has been an exciting time for the company, one of great
growth, progress and change. The steadfast financial backing of our shareholders
throughout our early development stages and in our recent initial public
offering has created a solid platform for continued growth and development.
"As the holiday season approaches and the year 2000 comes to a close, now is an
ideal time to share with you our many significant developments over the past
year or so, as well as our expected achievements in the coming months.
"Final Private Financing Round
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Thanks to leadership provided by InterWest Partners and New Medical
Technologies, we successfully completed our final private financing round in the
fall of 1999. This allowed for a significant enlargement of our development
capabilities and acceleration of programs in the respiratory and ophthalmology
areas. Importantly, this enabled us to move forward aggressively with a
successful Phase II trial of INS365 Ophthalmic for dry eye disease.
"Genentech Agreement
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This $78m landmark agreement was signed in December 1999. It is a broad
respiratory alliance involving rights to therapeutic indications such as chronic
bronchitis, cystic fibrosis and sinusitis. It is truly a partnership, as we are
working hand in hand with Genentech to move these programs rapidly forward. In
2000 we completed a Phase I/II trial of INS365 Respiratory in chronic bronchitis
patients, reached agreement with the FDA on a Phase II and III clinical plan,
and initiated a large multicenter Phase II trial. We also initiated and
completed Phase I testing of INS37217 Respiratory for cystic fibrosis,
triggering a milestone payment from Genentech. In 2001 we expect to achieve the
following milestones with Genentech:
[] Advance INS37217 Respiratory into Phase I/II for cystic fibrosis;
[] Initiate clinical testing of INS37217 Respiratory for sinusitis;
[] Complete patient enrollment in the multicenter Phase II trial of INS365
Respiratory for chronic bronchitis.
<PAGE>
"Initial Public Offering
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We were pleased to have successfully completed our initial public offering in
August of this year, selling 6,325,000 shares at $12/share. This provided the
company net proceeds of $69m for use in advancing our various discovery and
development programs, and for general corporate purposes, placing the company on
a solid financial foundation for future growth and achievement.
"Positive Phase II Results
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Just last month we announced that we completed a large multicenter Phase II
clinical trial of INS365 Ophthalmic for the treatment of dry eye disease, a
significant and widespread disorder of the ocular surface for which no
pharmacologically-active treatment is available. The trial produced positive
results, which will be presented at the upcoming Association for Research in
Vision and Ophthalmology (ARVO) meeting in late April. The data generated
supports moving the program directly into Phase III testing. We expect to
initiate two Phase III trials early next year, with their completion scheduled
for 2002.
"Post-IPO Accomplishments
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[] Signed a strategic alliance with Kirin Brewery Company's Pharmaceutical
Division for Asian rights to our lung-cancer diagnostic adjunct product,
INS316 Diagnostic;
[] Announced positive preclinical results for our novel therapeutic approach
for vaginal dryness, a painful disorder affecting pari- and post-menopausal
women;
[] Expanded our Intellectual Property estate. Inspire now has some three dozen
key patent filings, over half of which have issued in the US;
[] Selected as Healthcare/Pharmaceutical Company of the Year 2000 in North
Carolina by NCEITA, the NC Electronics and Information Technology
Association.
"The productivity of the Inspire staff is a model for the industry. We have
added a number of key employees over the past year or so, but remain a company
of less than 40. We are able to move our many drug discovery and development
programs along efficiently, thanks to the teamwork and dedication of all
employees. We expect to remain in this lean and nimble mode for the foreseeable
future, making good but selective use of external resources and strategic
partners, while retaining commercial rights in key markets.
"We are optimistic and enthusiastic about Inspire's future. We are bringing
forward novel approaches for the treatment of a number of serious diseases, ones
poorly treated by current therapies. These breakthrough treatments represent
large commercial opportunities in many cases, offering potentially substantial
returns to Inspire.
"In the coming years, we look forward to further progress on a number of
important therapeutic fronts, to the signing of new partnership agreements, and
to keeping you informed of other important milestones and achievements. Again,
thank you for your ongoing support of Inspire.
"Sincerely,
<PAGE>
"/s/ Christy L. Shaffer, Ph.D. /s/ Gregory J. Mossinghoff
"Christy L. Shaffer, Ph.D. Gregory J. Mossinghoff
President and Senior Vice President and
Chief Executive Officer Chief Business Officer
"Disclaimer: The forward-looking statements in this letter relating to
management's expectations and beliefs are based on preliminary information and
management assumptions. Such forward-looking statements are subject to a wide
range of risks and uncertainties that could cause results to differ in material
respects, including those relating to product development, revenue and earnings
expectations, intellectual property rights and litigation, competitive products,
results of clinical trials, the need for additional research and testing, delays
in manufacturing, funding, and the timing and content of decisions made by
regulatory authorities, including the U.S. Food and Drug Administration. Further
information regarding factors that could affect the Company's results is
included in the Company's filings with the Securities and Exchange Commission.
The Company undertakes no obligation to publicly release the results of any
revisions to these forward-looking statements that may be made to reflect events
or circumstances after the date hereof to reflect the occurrence of
unanticipated events."
* * * * *
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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.
Inspire Pharmaceuticals, Inc.
By: /s/ Gregory J. Mossinghoff
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Gregory J. Mossinghoff,
Senior Vice President and
Chief Business Officer
Dated: December 1, 2000
