Conference call on Q2 available till 8/12, and worth listening:
biz.yahoo.com
Interesting numbers in Goldberg's talk which I never heard or saw in print before: for oral heparin in a single dose there was 1.5 g UFH and 6.75 g carrier. For insulin it is ~6x less carrier and 50x less drug [so, about 1 g total in a capsule including 30 mg insulin]; for calcitonin ~20x less carrier [350 mg] and 1500x less drug [4 mg].
Novartis completed 1 year tox study on calcitonin - seemed OK.
Quaterly numbers:
biz.yahoo.com
Tuesday August 6, 7:01 am Eastern Time
Press Release
SOURCE: Emisphere Technologies, Inc.
Emisphere Technologies Reports Results For Second Quarter Of 2002
TARRYTOWN, N.Y., Aug. 6 /PRNewswire-FirstCall/ -- Emisphere Technologies, Inc. (Nasdaq: EMIS - News) today announced results for the second quarter ended June 30, 2002.
FINANCIAL RESULTS
The net loss for the three months ended June 30, 2002 was $24.9 million, or $1.39 per share, compared to a net loss of $11.6 million, or $0.65 per share, for the same period last year. Excluding the restructuring cost of $5.7 million identified on the Condensed Statement of Operations resulting from the discontinuation of all programs related to oral liquid heparin, the net loss for the second quarter was $19.2 million, or $1.07 per share. The net loss for the six months ended June 30, 2002 was $46.3 million, or $2.60 per share compared to $19.8 million, or $1.12 per share, for the same period last year. Excluding the restructuring costs, the net loss for the six months ended June 30, 2002 was $40.6 million, or $2.27 per share.
Operating expenses for the second quarter increased by $11.0 million compared to the same quarter last year as a result of:
Restructuring costs of $5.7 million. * Increased costs primarily associated with the oral liquid heparin
programs;
$1.0 million expended for the carrier manufacturing plant design, - $2.4 million expended on the overall expansion of research and
development/general and administrative costs and
$0.6 million increased depreciation expense.
* Increased Phase I clinical trial expense of $1.3 million for oral
insulin, cromolyn sodium, rhGH and solid heparin and low molecular
weight heparin studies.
In late May, following the conclusion of the PROTECT Trial, Emisphere scaled back its infrastructure associated with the oral liquid heparin program, resulting in a staff reduction of approximately 30%. This resulted in a $5.7 million restructuring charge that consisted of $1.1 million in severance cost, $0.3 million in clinical trial contract termination costs, $3.9 million in write-down of oral liquid heparin intangible assets and $0.5 million write-down of other assets. In addition, Emisphere continues to evaluate the recoverability of certain other fixed assets which may be impacted by its restructuring period.
The oral liquid heparin project expense for the second quarter, excluding the restructuring costs, was $5.6 million consisting of $3.8 million in clinical trial expense and $1.8 million in other expenses.
Revenues decreased by $0.3 million in the quarter, primarily due to the timing of reimbursements associated with Eli Lilly and Company partnership.
For the second quarter of 2002, Emisphere's cash, cash equivalents and investment usage was approximately $22.6 million. As of June 30, 2002, cash, cash equivalents and investments on hand totaled approximately $96.7 million.
As of June 30, 2002 Emisphere employed approximately 170 employees.
Alan W. Dunton, M.D., President and Chief Operating Officer of Emisphere Technologies, Inc., commented, "Based on the recently announced restructuring and focused business strategy, we believe that we have the cash resources to adequately fund our partnered and unpartnered programs through 2004."
PROGRAM UPDATES
As previously announced, Emisphere is focusing its research efforts on the creation of viable solid dosage forms, with the expectation of being able to improve patient compliance. Emisphere intends to use the safety database established in the PROTECT trial to facilitate the development of the solid dosage form, and is preparing for clinical testing of this new formulation containing the EMISPHERE (R) carrier, SNAC and heparin, based on recent primate results demonstrating success with an innovative formulation approach. The data suggest the potential feasibility of decreasing the heparin and carrier amounts. Emisphere is preparing the new SNAC/heparin formulation under GMP (Good Manufacturing Practices) conditions for clinical testing.
Throughout the second quarter, Emisphere continued to evaluate its oral insulin candidate in Type 2 diabetic patients. The most recent study is designed to evaluate the pharmacokinetics, absorption and blood glucose response levels in Type 2 diabetic patients after administering oral insulin with an EMISPHERE® carrier following the ingestion of a standardized meal. Emisphere also completed a 90-day toxicology study, in the second quarter. The data from this study will be used to prepare for multi-dose studies.
Emisphere also completed a multi-dose clinical study for an oral formulation of cromolyn sodium in the second quarter, and evaluated the safety and evidence of efficacy in an allergic population. Emisphere plans to continue evaluating an oral form throughout the remainder of 2002.
Emisphere and partner, Eli Lilly and Company (NYSE: LLY - News) have completed initial proof-of-concept Phase I studies to evaluate an oral formulation of parathyroid hormone (PTH 1-34) and are continuing to work towards developing a final image product. Novartis AG (NYSE: NVS - News) is engaged in progressing with Phase II testing to evaluate an oral form of salmon calcitonin, and has recently completed long term toxicology studies. Emisphere recently announced that it began a clinical study to evaluate an oral formulation of recombinant human growth hormone (rhGH). The oral formulation, also being developed in collaboration with Lilly, combines an EMISPHERE® delivery agent with rhGH. The rhGH program is the second program with Lilly to enter clinical testing.
With the entrance of the rhGH program into the clinic, Emisphere now has six different EMISPHERE® carriers in clinical testing.
In addition, Emisphere entered into new feasibility agreements in additional therapeutic areas.
Michael M. Goldberg, M.D., Chairman and Chief Executive Officer of Emisphere Technologies, Inc., concluded, "While we did not meet our endpoints in the recent PROTECT trial, the performance of the EMISPHERE® technology in this study was encouraging and demonstrates the potential to provide an important contribution to therapeutic candidates. Clearly we accomplished an important milestone, showing for the first time in a large patient population that the oral delivery of a macromolecule was possible. In addition, the data we have compiled indicates that we were able to demonstrate comparable efficacy with a statistically significant reduction in serious adverse events. The PROTECT trial results will be submitted shortly to a peer-reviewed journal for potential publication. The PROTECT trial demonstrated the need for an improved formulation, and we are excited by the progress we have made with the solid dosage form of heparin, based on recent data in primates, which is encouraging. The results from PROTECT have generated interest from both existing and potential partners about our technology. In addition, as indicated previously, our other partnered programs are actively progressing."
ABOUT EMISPHERE TECHNOLOGIES
Emisphere Technologies, Inc. is a biopharmaceutical company pioneering the oral delivery of otherwise injectable or inhaled drugs. By applying its unique carrier technology, Emisphere has taken a leadership position in solving the oral delivery of proteins, peptides and other macromolecules produced by both pharmaceutical and biotechnology companies. Eight Emisphere formulations have advanced into clinical trials being conducted by Emisphere and its partners. Emisphere develops pharmaceutical products for its own portfolio and has several strategic alliances and ongoing feasibility studies with many of the world's leading pharmaceutical and biotechnology companies.
CONFERENCE CALL INFORMATION
Emisphere will hold a teleconference to discuss its second quarter financial results for 2002 on August 6, 2002 beginning at 10:30 a.m. Eastern Time (7:30 a.m. Pacific Time). A replay of the teleconference will be made available for 72 hours and will be accessible two hours following the end of the call.
The dial-in information is as follows: Conference ID # 4856304
Domestic callers: 888-218-7281; Replay: 800-642-1687;
International callers: 706-679-5765; Replay: 706-645-9291
Emisphere will simultaneously be webcasting this teleconference. To access the conference in listen-only mode please go to the investor relations portion of our website: emisphere.com. Please visit the site at least five minutes prior to start time for instructions.
Emisphere Safe Harbor Statement Regarding Forward-looking Statements
The statements in this release and oral statements made by representatives of Emisphere relating to matters that are not historical facts (including without limitation those regarding the timing or potential outcomes of research collaborations or clinical trials, any market that might develop for any of Emisphere's product candidates and the sufficiency of Emisphere's cash and other capital resources) are forward-looking statements that involve risks and uncertainties, including, but not limited to, the likelihood that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the United States or abroad, the ability of Emisphere and/or its partners to develop, manufacture and commercialize products using Emisphere's drug delivery technology, Emisphere's ability to fund such efforts with or without partners, and other risks and uncertainties detailed in Emisphere's filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in Emisphere's Annual Report on Form 10-K (file no. 1-10615) filed on April 1, 2002.
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