Expected to strengthen Teva's core CNS franchise, establish Teva's leadership in underserved movement disorders space, provide compelling new treatment options for patients in need, and enhance Teva's long-term revenue and earnings growth
All-Cash Transaction with Enterprise Value of
Auspex is an innovative biopharmaceutical company specializing in applying deuterium chemistry to known molecules to create novel therapies with improved safety and efficacy profiles. Its lead investigational product, SD-809 (deutetrabenazine), which leverages Auspex's deuterium technology platform is being developed for the potential treatment of chorea associated with Huntington's disease, tardive dyskinesia, and Tourette syndrome, with a pharmacokinetic profile that allows for lower doses resulting in a favorable safety profile.
In 2014, Auspex reported positive results from its Phase 3 clinical trial for SD-809 in Huntington's disease, with plans to submit a New Drug Application (NDA) for this indication by mid-2015. SD-809 has been granted orphan drug designation for the treatment of
- Excellent strategic fit – strengthens Teva's leadership position within CNS and expands presence into underserved movement disorder markets
- Teva's existing capabilities and infrastructure in CNS are expected to accelerate the potential for SD-809 and Auspex's additional pipeline assets
- Near-term value creation – SD-809 for Huntington's disease is expected to be approved and launched commercially in 2016
Deep pipeline and proven deuterium chemistry technology supports multiple platforms for growth
- SD-809 is currently in Phase 3 for tardive dyskinesia and Phase 1 for Tourette syndrome
- SD-560 (deuterated pirfenidone) is currently in development for idiopathic pulmonary fibrosis
- Additional candidates identified for deuterium chemistry platform that are aligned with Teva's strategy
- Enhances Teva's mid to long-term revenue and earnings growth, profitability, and product diversity - expected to be accretive to non-GAAP EPS beginning in 2017 and meaningfully accretive thereafter, and diversifies Teva's Specialty medicines product mix
"The acquisition of Auspex is a significant step in strengthening Teva's leadership position in CNS and advances us into underserved movement disorder markets. We look forward to accelerating the development and commercialization of the Auspex portfolio based on our infrastructure, capabilities and strong commercial and R&D position in CNS. As we have outlined recently, one of our key priorities for 2015 is to support Teva's mid to long-term growth and create value for our shareholders with business development opportunities that are closely aligned with our core therapeutic areas. This transaction represents a first major step with regards to that commitment and we expect to continue this focus in the future," said Erez Vigodman, President and CEO of Teva.
"We believe that the application of Auspex's deuterium platform to known pharmaceuticals holds great promise across a wide spectrum of neurological diseases and associated movement disorders, including Huntington's disease, tardive dyskinesia and Tourette syndrome. Auspex's lead candidate, SD-809, offers compelling efficacy and safety benefits to patients, as demonstrated by the impressive Phase 3 topline data in Huntington's disease announced in December 2014," said
"Teva has established itself as a global leader in CNS diseases, characterized by strong management and commercial execution," said
Financial Benefit to Teva
The acquisition of Auspex is expected to generate value and enhance Teva's mid to long-term revenue and earnings growth profile. Teva expects the transaction to begin contributing to revenues in 2016 with the anticipated launch of SD-809 for Huntington's disease and to be accretive to non-GAAP EPS beginning in 2017 with minimal dilution to non-GAAP EPS in the second half of 2015 and 2016. The transaction is expected to be funded with cash on hand and is not subject to any financing contingencies.
Under the terms of the merger agreement, an affiliate of Teva will promptly commence a tender offer to acquire all of the outstanding shares of Auspex's common stock for
The consummation of the tender offer is subject to various conditions, including a minimum tender of a majority of outstanding Auspex shares, the expiration or termination of any applicable waiting periods under applicable competition laws, and other customary conditions. Pending such closing conditions, Teva expects the transaction will close in mid-2015.
Live Conference Call for Investors:
A conference call and a live webcast with slides will be hosted on
Teva's Safe Harbor Statement under the
This release contains forward-looking statements, which are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements about the planned acquisition of Auspex, the expected financial impact and benefits to Teva of such acquisition, and anticipated milestones and other expectations regarding Auspex's product development activities and clinical trials. Important factors that could cause or contribute to such differences include risks relating to: the possibility that the transaction with Auspex will not be completed, including due to the failure to obtain the minimum tender condition; uncertainties as to the timing of the transaction; the possibility that the expected benefits of the transaction will not be fully realized by us or may take longer to realize than expected; future results of on-going or later clinical trials for Auspex's product candidates, including SD-809; our ability to obtain regulatory approvals and commercialize Auspex's product candidates following the closing and market acceptance of such products; our ability to develop and commercialize additional pharmaceutical products; competition for our innovative products, especially Copaxone®(including competition from orally-administered alternatives, as well as from potential purported generic equivalents) and our ability to migrate users to our 40 mg/mL version; the possibility of material fines, penalties and other sanctions and other adverse consequences arising out of our ongoing FCPA investigations and related matters; our ability to achieve expected results from the research and development efforts invested in our pipeline of specialty and other products; our ability to reduce operating expenses to the extent and during the timeframe intended by our cost reduction program; our ability to identify and successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; the extent to which any manufacturing or quality control problems damage our reputation for quality production and require costly remediation; increased government scrutiny in both the U.S. and
Auspex Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements. Any statements contained herein which do not describe historical facts, including but not limited to, statements regarding: the proposed transaction between Teva and Auspex; the expected timetable for completing the transaction; strategic and other potential benefits of the transaction. Such risks and uncertainties include: the possibility that certain closing conditions to the transaction will not be satisfied; that required regulatory approvals for the transaction may not be obtained in a timely manner, if at all; the ability to timely consummate the transaction and possibility that the transaction will not be completed; and other factors that are discussed in Auspex's Annual Report on Form 10-K for the year ended
About the Tender Offer
THE PRESS RELEASE IS FOR INFORMATIONAL PURPOSES ONLY AND IS NOT AN OFFER TO BUY OR THE SOLICITATION OF AN OFFER TO SELL ANY SHARES OF AUSPEX COMMON STOCK. THE TENDER OFFER DESCRIBED IN THIS DOCUMENT HAS NOT YET COMMENCED.
At the time the offer is commenced, an affiliate of Teva will file a Tender Offer Statement on Schedule TO with the
The Offer to Purchase, the related Letter of Transmittal and certain other offer documents, as well as the Solicitation/Recommendation Statement, will be made available to all stockholders of Auspex at no expense to them. The Tender Offer Statement and the Solicitation/Recommendation Statement will be available without charge at the
AUSPEX STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING THE OFFER TO PURCHASE, RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT, INCLUDING ALL AMENDMENTS TO THOSE MATERIALS. SUCH DOCUMENTS WILL CONTAIN IMPORTANT INFORMATION, WHICH SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER.
Additional Information and Where to Find It
In addition to the Solicitation/Recommendation Statement, Auspex files annual, quarterly and current reports, proxy statements and other information with the
Please call the
Kevin C. Mannix, 215-591-8912
Ran Meir, 215-591-3033
Tomer Amitai, 972 (3) 926-7656
Iris Beck Codner, 972 (3) 926-7687
Denise Bradley, 215-591-8974
Nancy Leone, 215-284-0213
Monique Allaire Lyons, 781-631-0759
Dan Budwick, 973-271-6085