Financial Statement 10/11
Year End Report, Stockholm, October 13, 2011
September 1, 2010 - August 31, 2011
Fourth quarter report for Diamyd Medical AB (publ.), fiscal year
2010/2011
(www.omxgroup.com ticker: DIAM B; www.otcqx.com ticker: DMYDY)
Fourth quarter, June 1, 2011 - August 31, 2011
· Group net sales for the fourth quarter were MSEK 2.2 (110.2)
· Loss before tax for the fourth quarter was MSEK -26.5 (75.0)
· Earnings per share after dilution for the fourth quarter were SEK
-0.9 (2.6)
· The Group's liquid assets and short term investments amounted to
MSEK 435.6 (501.3) as of August 31, 2011
Full year, September 1, 2010 - August 31, 2011
· Group net sales for the year were MSEK 280.8 (113.0)
· Profit before tax for the year was MSEK 101.8 (-0.3)
· Earnings per share after dilution for the year were SEK 3.5 (-0.0)
Significant events during the reporting period June 1, 2011 - August 31,
2011
· Diamyd Medical regained all rights and thereby the control of the
diabetes therapy Diamyd®after Ortho-McNeil-Janssen Pharmaceuticals, Inc.
(OMJPI) terminated collaboration agreement
· Diamyd Medical closed European Phase III study and initiated closure
of US Phase III study with Diamyd®
· TrialNet presented results from a study with Diamyd®, which did not
show a statistically significant effect of the study drug
· Diamyd Medical presented detailed results of European Phase III
study with Diamyd®
· Diamyd Medical increased shareholding in Protein Sciences
Corporation
· Diamyd Medical appointed Peter Zerhouni as President
· Diamyd Medical put focus on pain projects and reduced costs
Significant events after the reporting period
· Diamyd Medical was awarded three million dollar grant and expanded
the NTDDS portfolio
CEO COMMENTS
After the setback this spring, in which the results of the Company's
European Phase III study with the diabetes vaccine did not meet
expectations, we have shifted the focus of the Company and reduced
costs. The cash of more than SEK 400 million is carefully managed while
the work of shaping future strategies and business plans is underway.
Our resources are now mainly directed towards the development projects
based on the Company's patented NTDDS platform. NTDDS (Nerve Targeting
Drug Delivery System) is an innovative technology for delivering drugs
directly to the nervous system, providing a local effect in the cells
targeted by the treatment, without affecting the rest of the body. The
technology has potential to be used for the treatment of chronic pain as
well as many other indications in the nervous system.
The top priority right now is the Company's ongoing US Phase II study
with the NTDDS-based drug candidate NP2 Enkephalin for the treatment of
pain caused by cancer. Intensive recruitment efforts are underway to
enroll the remaining third of the participants to the study; several new
clinics have been contracted and additional resources have been
allocated to the recruitment campaign. Recruitment rates have varied
considerably over time, making it difficult to provide a forecast of
when the recruitment of the study will be completed. Results from the
study are estimated to be reported sometime between January and June
2012. The Company plans to begin clinical studies with the next
NTDDS-based drug candidate for the treatment of pain, NG2 GAD, after
evaluation of the study results with NP2 Enkephalin.
Recently Diamyd Medical was, together with the University of Michigan,
awarded a three million dollar grant from the US National Institutes of
Health (NIH) to develop another drug candidate from the NTDDS platform,
NN1 Neurotrophin. This drug candidate is being developed for prevention
of nerve damage caused by chemotherapy, i.e. chemotherapy induced
peripheral neuropathy, which many cancer patients are afflicted by. It
is positive that a highly respected institution such as the NIH has
decided to contribute to the development of this drug candidate.
The negotiations are advancing with the University of Florida, which
filed a lawsuit against the Company for a part of the upfront payment
received under the license agreement with Ortho-McNeil-Janssen
Pharmaceuticals, Inc., regarding the diabetes vaccine. With regard to
the claims the Company has chosen to reserve the equivalent of two
million dollars in the financial accounts as per August 31, 2011.
Several researcher-initiated studies with the diabetes vaccine are still
ongoing. The Swedish study, aiming to prevent type 1 diabetes in
children at high risk of developing the disease, is particularly
exciting to follow.
In September Diamyd Medical participated in an international seminar in
Lisbon, Portugal, where the question of how to successfully counteract
type 1 diabetes was in focus. The meeting gathered many of the foremost
researchers and companies within the field. There was a great interest
in the Company's research and how the active substance in the diabetes
vaccine, GAD65, may contribute to an efficient therapy for type 1
diabetes. We continue to work with our worldwide network within diabetes
to be able to identify new possibilities for the diabetes vaccine, which
has shown a good safety profile in extensive clinical studies.
Stockholm, October 13, 2011
Peter Zerhouni
President and CEO Diamyd Medical AB
SIGNIFICANT EVENTS DURING THE REPORTING PERIOD
JUNE 1, 2011 - AUGUST 31, 2011
Diamyd Medical regained all rights and thereby the control of the
diabetes therapy Diamyd® after Ortho-McNeil-Janssen Pharmaceuticals,
Inc. (OMJPI) terminated collaboration agreement.
Ortho-McNeil-Janssen Pharmaceuticals, Inc. elected to terminate the
agreement that was signed in June 2010 to develop and commercialize
Diamyd®, and Diamyd Medical regained all rights to the diabetes therapy.
The termination of the agreement followed the evaluation of the results
of the European Phase III study, reported on May 9, 2011.
Diamyd Medical closed European Phase III study and initiated closure of
US Phase III study with Diamyd®.
The company decided not to complete the follow-up period of the European
Phase III study of the antigen-based diabetes therapy Diamyd®, which did
not meet the primary efficacy endpoint. Following consultation with the
US Food and Drug Administration (FDA), Diamyd Medical also decided to
suspend dosing in the Company's parallel US Phase III study and to
initiate closure of the study.
TrialNet presented results from a study with Diamyd® which did not show
a statistically significant effect of the study drug.
The results of a study with Diamyd Medical's antigen-based diabetes
therapy Diamyd®, conducted by the research consortium Type 1 Diabetes
TrialNet, did not show a statistically significant effect of the study
drug.
Diamyd Medical presented detailed results of European Phase III study
with Diamyd®.
The Company reported detailed results from the European Phase III study
of the antigen-based diabetes therapy Diamyd®, which did not meet the
primary efficacy endpoint. Patients treated with Diamyd® had on average
16.4 percent more remaining C-peptide at 15 months compared to those who
received placebo. The p-value of the primary endpoint was 0.10.
Diamyd Medical increased shareholding in Protein Sciences Corporation.
Diamyd Medical's convertible promissory note in the US vaccine company
Protein Sciences Corporation was converted into shares. The promissory
note was accounted for as an investment of SEK 6.4 million as of
November 30, 2007. After conversion, the Company holds about 8 percent
of the Protein Sciences Corporation shares.
Diamyd Medical appointed Peter Zerhouni as President.
The Board of the Company appointed the former Acting President of Diamyd
Medical AB, Peter Zerhouni, as President of the Company. Peter Zerhouni
has been involved in all aspects of the Company since 2006. He assumed
his position as President and CEO on July 4, 2011.
Diamyd Medical put focus on pain projects and reduced costs.
Diamyd Medical announced that the Company has chosen to concentrate its
resources on the Company's drug candidates for the treatment of pain and
diseases of the nervous system. The termination of the Phase III program
with the diabetes therapy Diamyd® means significantly lower costs for
the Company which creates strategic leeway.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
Diamyd was awarded three million dollar grant and expanded the NTDDS
portfolio.
Diamyd Medical with collaborators received a three million dollar grant
from the US National Institutes of Health to develop the Company's
patented Nerve Targeting Drug Delivery System (NTDDS) for prevention of
Chemotherapy Induced Peripheral Neuropathy. The grant allows Diamyd
Medical to expand the NTDDS technology to also target neuropathy, in
addition to the Company's development portfolio for the treatment of
pain.
*** To read the complete report, please see attached pdf, or visit
www.diamyd.com ***
