Addex Pharmaceuticals First Half 2011 Financial Results
Geneva, Switzerland, 27 July 2011 – Addex Pharmaceuticals (SIX: ADXN), a leader in allosteric modulation-based drug discovery and development, announced today financial results for the first half of 2011 and reviewed the status of its pipeline.
“We are happy with the progress we have made in the first half of 2011. Our most advanced pipeline products are advancing through Phase IIa testing, we have a strong cash position and we are operating with a more efficient organization,” said André Mueller, Executive Chairman of Addex Pharmaceuticals. “The search for a new CEO has been fruitful and we hope to announce the appointment of our new CEO in the coming weeks.”
Tim Dyer, CFO of Addex Pharmaceuticals, said: “We are pleased to report cash utilization in line with estimates and maintain our full year cash utilization guidance at CHF28–30 million. The ongoing re-organization is on track to deliver significant improvements in operational efficiency and cash utilization and we now expect our cash reserves to reach to the end of 2013, without taking into account any new partnership revenues.”
Key Financial Data
|CHF’ thousands||H1 2011||H1 2010||Change|
|Income||3 173||2 700||18%|
|R&D expenses||(14 558)||(16 686)||(13%)|
|G&A expenses||(3 299)||(3 289)||-|
|Total operating loss||(14 684)||(17 275)||(15%)|
|Finance result, net||(143)||13||-|
|Net loss for the period||(14 827)||(17 262)||(14%)|
|Basic and diluted net loss per share||(2.07)||(3.01)||(31%)|
|Net cash used||(13 567)||(19 873)||(32%)|
|CHF’ thousands||Jun. 30, 2011||Dec. 31, 2010||Change|
|Cash and cash equivalents||50 230||63 797||(21%)|
|Shareholders’ equity||49 814||64 414||(23%)|
First Half 2011 Financial Summary
Income was CHF3.2 million for the first half of 2011 (H1 2010: CHF2.7 million) including a CHF2.6 million milestone payment received from Janssen Pharmaceuticals, Inc. (JPI), formerly Ortho-McNeil-Janssen Pharmaceuticals, Inc. under the mGluR2 PAM license agreement, CHF0.1 million of technology access fees from Merck & Co. under the mGluR4 PAM license agreement, CHF0.2 million of French research tax credits for 2011 and a CHF0.2 million grant received from The Michael J. Fox Foundation for Parkinson’s Research.
Research & Development expenses decreased by 13% to CHF14.6 million in the first half of 2011 compared to CHF16.7 million in the first half of 2010, mainly due to our reduced headcount.
General and Administration expenses remained stable at CHF3.3 million.
Net Loss decreased to CHF14.8 million for the first half of 2011, compared to CHF17.3 million for the first half of 2010, mainly due to the significant decrease in our operating expenses.
Cash and cash equivalents amounted to CHF50.2 million at 30 June 2011, compared to CHF63.8 million at the end of 2010. Cash used for the first half of 2011 of CHF13.6 million is mainly due to the cash used in operations.
Outlook: Based on current expectations, full year cash spend guidance is CHF28-32 million.
Reorganization: While steps have been taken to ensure that the reorganization retained key talent and core competencies it is expected to yield significant savings. The consultation period required under Swiss law has been completed and the affected staff members have been notified. Staff will be reduced from 111.8 full time equivalents (FTEs) at June 30 to 82 FTEs by September 30. Pipeline prioritization and strategy review efforts are underway and will be finalized after the new CEO has been appointed.
Pipeline Status Review
The lead partnered product candidate, ADX71149, an mGluR2-targeted positive allosteric modulator (PAM), or activator, in clinical development for the treatment of schizophrenia, started Phase IIa clinical testing in patients with schizophrenia earlier this year. ADX71149 was discovered in collaboration with JPI as part of a drug discovery and development partnership initiated in 2005. JPI is responsible for development and commercialization of ADX71149. Addex is eligible for a further €109 in development and regulatory milestones and low double-digit royalties.
The lead wholly-owned clinical product candidate, dipraglurant is an mGluR5-targeted negative allosteric modulator (NAM), or inhibitor. An immediate release formulation, dipraglurant-IR, which mimics the pharmacokinetic profile of levodopa, is currently undergoing Phase IIa clinical testing in Parkinson’s disease levodopa-induced dyskinesia (PD-LID) patients. The Michael J Fox Foundation for Parkinson’s Research awarded Addex a $900,000 grant to support this PD-LID study.
Inhibition of mGluR5 has been validated in several indications. Addex has chosen to focus on PD-LID because PD-LID represents a significant and growing unmet medical need. In addition, the lead compound, dipraglurant, demonstrated exceptional efficacy in preclinical testing. Dipraglurant-IR effectively inhibited, in a dose dependent manner, chorea and dystonia, the two key movement disorders associated with levodopa-induced dyskinesia. Dipraglurant-IR is the only drug candidate under development that has been reported to have efficacy effects on both chorea and dystonia in representative preclinical models. In addition, the highest tested dose of dipraglurant-IR completely abolished both chorea and dystonia in many of the non-human primates in preclinical testing, which has not been reported with other compounds.
An extended-release formulation, dipraglurant-ER, is also being developed by Addex. Dipraglurant-ER is expected to be optimal for several other indications where mGluR5 inhibition has been clinically validated, e.g. dystonia, anxiety, depression, pain, GERD as well as addictive or compulsive behaviors. While the majority of these conditions can frequently be co-morbid with Parkinson’s disease, dipraglurant-ER may also be tested as a treatment for these indications in non-PD patients.
Addex has a partnership with Merck & Co., Inc. for the development of mGluR4 PAM drug candidates for treatment of Parkinson’s disease. The mGluR4-targeted PAM partnership signed in late 2007 has achieved two preclinical milestones and the collaborative discovery phase of the agreement has been successfully completed. Merck is responsible for future development of mGluR4 PAM. Addex is eligible for up to a total of USD167 million in milestones plus royalties.
Under a separate agreement, Addex will regain from Merck & Co., Inc. its intellectual property surrounding ADX63365 and other mGluR5-targeted PAM candidates and backup candidates, a novel approach for treating schizophrenia. The decision ends a 2008 license agreement under which Merck had received exclusive rights to mGluR5-targeted PAM.
A webcast and conference call will be held at 4pm CEST (3pm BST/10am EST) today. To participate, please listen to the webcast or call one of the following telephone numbers:
+41 91 610 56 00 (Europe)
+44 203 059 58 62(UK)
+1 866 291 4166 (USA)
The live webcast, slides, webcast replay and transcript, will be available at www.addexpharma.com. The condensed consolidated interim financial statements can be found here.
No password or RSVP is necessary.
Addex Pharmaceuticals (www.addexpharma.com) discovers and develops allosteric modulators for human health. The company uses its proprietary small molecule discovery platform to target cell surface receptors that are recognized as having therapeutic potential for treating important neurological, metabolic or inflammatory diseases. Separate Phase IIa clinical trials are ongoing for dipraglurant (ADX48621) to treat PD-LID and ADX71149 to treat schizophrenia in collaboration with Janssen Pharmaceuticals, Inc. In addition, Merck & Co., Inc. has licensed rights to preclinical mGluR4 PAM for Parkinson's disease. Unpartnered products in preclinical testing include: follicle stimulating hormone receptor (FSHR) NAM, with potential for treatment of endometriosis and benign prostatic hyperplasia; mGluR2 NAM for treating Alzheimer's disease; and GABA-BR PAM with potential for treatment of chronic pain, Fragile X syndrome, urinary incontinence and gastroesophageal reflux disease. Discovery programs include GLP-1R PAM and related receptors, the IL1R1 and the interleukin receptor family, TrkB and the receptor tyrosine kinase superfamily as well as the TNFR1 and the TNF receptor superfamily.
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Disclaimer: The foregoing release may contain forward-looking statements that can be identified by terminology such as "not approvable", "continue", "believes", "believe", "will", "remained open to exploring", "would", "could", or similar expressions, or by express or implied discussions regarding Addex Pharmaceuticals Ltd, its business, the potential approval of its products by regulatory authorities, or regarding potential future revenues from such products. Such forward-looking statements reflect the current views of Addex Pharmaceuticals Ltd regarding future events, future economic performance or prospects, and, by their very nature, involve inherent risks and uncertainties, both general and specific, whether known or unknown, and/or any other factor that may materially differ from the plans, objectives, expectations, estimates and intentions expressed or implied in such forward-looking statements. Such may in particular cause actual results with allosteric modulators of mGluR2, mGluR4, mGluR5, mGluR7 or other therapeutic targets to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that allosteric modulators of mGluR2, mGluR4, mGluR5, mGluR7 will be approved for sale in any market or by any regulatory authority. Nor can there be any guarantee that allosteric modulators of mGluR2, mGluR4, mGluR5, mGluR7 or other therapeutic targets will achieve any particular levels of revenue (if any) in the future. In particular, management's expectations regarding allosteric modulators of mGluR2, mGluR4, mGluR5, mGluR7 or other therapeutic targets could be affected by, among other things, unexpected actions by our partners, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; competition in general; government, industry and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Addex Pharmaceuticals Ltd is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise, except as may be required by applicable laws.