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Penwest Shareholders Letter 2009
Dear Fellow Penwest Shareholder:
Over the past year, we have remained focused on achieving the goals set out in our business plan
to create value for you, the shareholders of Penwest. Facing a challenging economic environment,
and with limited cash resources and important decisions to be made in our business, we adopted a
plan for 2009 with narrowed priorities and a set of clearly defined, measurable goals, and we set
out to execute our plan. We believed that this plan would build shareholder value in the short-term
and prepare the Company for long-term growth.
In 2009, our revenues were up substantially over 2008, while our SG&A and R&D expenses were
down approximately 22% and 41%, respectively, and our net loss was cut by $25 million. We have
now posted three consecutive quarters of profitability beginning with our third quarter of 2009, and
we expect full-year profitability for 2010.
The market has, in turn, reflected our achievements as the value of your shares in Penwest has
appreciated more than 100% since early 2009, when we began to implement our focused business
plan. In addition, our board of directors has announced its intent to return cash to shareholders
through a special dividend that the board intends to declare in the fourth quarter of 2010.
Looking Back
Last year was marked by significant accomplishments for the Company, with substantial progress
in each of the primary areas of our business. Specifically, we:
- Continued to work with Endo to maximize the value of Opana ER through a
collaboration for developing, marketing and selling the product. In 2009, we and
Endo signed a licensing agreement with Valeant Pharmaceuticals for Canada, Australia
and New Zealand, and we are continuing to support Endo’s efforts to license Opana ER
elsewhere around the world.
- Took steps to protect the Opana ER franchise in the U.S. We recently announced a
settlement of the Opana ER patent litigation with Barr Laboratories, Inc., which followed a
previously announced settlement with Actavis South Atlantic LLC. Under the terms of the
recent settlement with Barr, Penwest and Endo agreed to grant Barr a license to sell a
generic version of Opana ER on or after September 15, 2012, or earlier under certain
circumstances. Together with Endo, we are continuing the Opana ER patent litigation
against other generic filers that we believe have infringed upon our patents, and we are
prosecuting multiple additional patent applications that are not the subject of either the
current litigation or the settlement agreements.
- Successfully completed our Phase Ib clinical trial of A0001 and advanced the
compound into two separate Phase IIa trials. In the Phase Ib trial, A0001, a coenzyme
Q10 analog demonstrated to improve mitochondrial function in-vitro, was well tolerated by
subjects, and no serious adverse events were reported. In addition, we observed a dosedependent
increase in exposure following repeat dosing and were able to establish a
maximum tolerated dose. Based on these results, we designed and commenced two
Phase IIa trials in two rare orphan disorders that currently have no approved treatments.
One trial is in patients with Friedreich’s Ataxia, and the other is in patients with an A3243G
mitochondrial DNA point mutation and impaired mitochondrial function typically associated
with the MELAS syndrome. The trials are designed to demonstrate proof of concept
regarding biological activity of the drug. We also selected an additional compound – a new
chemical entity – from Edison Pharmaceuticals. We plan to decide the next steps for this
compound based on the Phase IIa data from A0001.
- Further developed our drug delivery business based on the technology we used
successfully with Opana ER. We achieved a success-based development milestone –
and the accompanying payment – under our first collaboration agreement with Otsuka
Pharmaceutical, entered into our third and fourth research and development agreements
with Otsuka and, most recently, reached a multi-drug generics agreement with Alvogen,
Inc. This new partnership allows us to leverage our drug delivery technology for the
formulation of generic drugs, an important segment of the market for extended release
technology.
We achieved these goals while right-sizing the organization to align with our current priorities and
significantly reducing the Company’s combined SG&A and R&D expenses in 2009 by
approximately 34% compared with 2008, and by 42% compared with 2007.
Moving Forward
To build upon our successes and deliver further growth, we are hard at work implementing a
clearly-defined business plan for 2010. Our objectives include:
- Working closely with Endo to maximize the value of Opana ER.
- Completing both Phase IIa trials of A0001, analyzing the data and making a “go/no-go”
decision on this compound by the third quarter of 2010.
- Exploring potential licensing opportunities for A0001 in anticipation of the completion of the
Phase IIa trials.
- Growing the Company’s drug delivery business both by completing formulation work on
compounds under development and by signing additional deals.
- Continuing to aggressively manage our expenses to ensure our costs are appropriate given
our priorities.
I thank my colleagues at Penwest for their steadfast commitment to our Company and our mission
on behalf of patients with unmet medical needs and their families. It is the hard work and
dedication of our entire team that ensures our continued focus on our priorities for 2010 and
beyond.
Our Board and management team are confident in Penwest's future and are energized by the
progress the Company is making. We greatly appreciate your support as we continue to pursue
the right path for Penwest to build value for all of Penwest's shareholders.
Sincerely,
Jennifer L. Good
President and Chief Executive Officer
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