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8-K - FORM 8-K - CPEX Pharmaceuticals, Inc. | b79897e8vk.htm |
Exhibit 99.1
FOR IMMEDIATE RELEASE
Contacts: |
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Bob Hebert |
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Chief Financial Officer
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Chad Rubin | |||
CPEX Pharmaceuticals, Inc.
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The Trout Group | |||
603.658.6100
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646.378.2947 | |||
rhebert@cpexpharm.com
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crubin@troutgroup.com |
CPEX Pharmaceuticals Reports 2009 Fourth-Quarter and Year-End Financial Results
Exeter, NH, March 3, 2010 CPEX Pharmaceuticals, Inc. (NASDAQ: CPEX) today reported
financial results for the fourth quarter and year ended December 31, 2009. For the quarter CPEX
reported revenues of $5.2 million and a net loss of $498,000. For the year CPEX reported revenues
of $18.7 million and a net loss of $3.0 million.
Operating expenses for the year ended December 31, 2008 include a $1.2 million non-cash charge
resulting from the modification of equity awards and $2.5 million of expenses related to the
spin-off from Bentley Pharmaceuticals on June 30, 2008.
Fourth-Quarter Highlights
For the fourth quarter of 2009 compared to the fourth quarter of 2008:
| Revenues increased 23% to $5.2 million from $4.2 million. | ||
| Operating expenses increased 45% to $5.8 million from $4.0 million. | ||
| Net loss was $498,000, or $0.20 per share, compared to net income of $292,000, or $0.12 per share. |
The growth in revenues for the fourth quarter of 2009 was due to increased royalties on sales
of Testim®. This growth is due to a reported 13.2% increase in prescriptions for Testim
during the fourth quarter of 2009 compared to the same period in 2008.
General and administrative expenses for the fourth quarter of 2009 increased $1.1 million
compared to the fourth quarter of 2008 due to $1.2 million in costs relating to the Upsher-Smith
litigation. Research and development expenses for the fourth quarter of 2009 increased $627,000
compared to the fourth quarter of 2008 largely due to a $489,000 increase in expenses related to
the Nasulin clinical program. Research and development expenses are expected to vary from period to
period, primarily due to the number, size and recruitment levels of clinical trials in any given
reporting period.
Year-to-Date Highlights
For the year ended December 31, 2009 compared to the comparable period in 2008:
| Revenues increased 20% to $18.7 million from $15.6 million. | ||
| Operating expenses increased 16% to $21.9 million from $18.8 million. | ||
| Net loss increased to $3.0 million, or $1.21 per share, from $2.9 million, or $1.25 per share. |
The increase in revenues for the twelve months ended December 31, 2009 was due to increased
royalties on sales of Testim®. For the year ended December 31, 2009, Testim
prescriptions were reported to have grown 14.9% compared to the same period in 2008. General and
administrative expenses increased $2.4 million in the year ended December 31, 2009 compared to the
same period in 2008. The increase was primarily due to increased litigation costs of $2.8 million
partially offset by a $674,000 decrease in non-cash share-based compensation expense. Research and
development expenses increased $3.2 million during the year ended December 31, 2009 compared to
2008 due to a $3.7 million increase in clinical trial expenses, primarily related to the Nasulin
clinical program, which were partially offset by lower non-cash share-based compensation expense of
$494,000.
On June 30, 2008, CPEX had approximately 2,274,000 common shares outstanding after the
spin-off. The same number of shares is being used for the basic and diluted loss per share
computation for all periods presented prior to June 30, 2008 because no CPEX equity awards were
outstanding prior to the spin-off.
As of December 31, 2009, CPEX had unrestricted cash of approximately $13.7 million, working
capital of $16.6 million and no debt.
Business Update
Ongoing Clinical Trials: CPEXs intranasal insulin product candidate for the treatment of
hyperglycemia in patients with Type 1 and Type 2 diabetes, Nasulin, is continuing in clinical
trials evaluating the efficacy and safety profile of the product. CPEX has completed enrollment in
its Phase 2a study designed to assess the efficacy and safety of Nasulin versus placebo over a
6-week treatment period. This study was conducted at multiple sites in the U.S. and randomized 94
patients. Data analysis is ongoing and preliminary results are expected this month. Earlier
clinical studies of Nasulin indicated that CPEXs intranasal insulin candidate achieved a faster
time to peak plasma insulin levels when compared to other approved rapid-acting insulin therapies,
thereby more closely mimicking the natural response of the pancreas to meals.
Patent Infringement Lawsuit Update: CPEX and Auxilium Pharmaceuticals, Inc. continue to vigorously
pursue their lawsuit against Upsher-Smith for infringement of CPEXs patent that covers Testim. In
August 2009, the U.S. Food and Drug Administration (FDA) responded to a Citizen Petition filed by
Auxilium. The FDA agreed with some of the statements made in the Citizen Petition regarding the
testing required for generic versions of Testim, while disagreeing with other statements. While
the FDA did not comment upon any particular filing, the agency stated that: The practical effect
of this determination is that any application for a testosterone gel product that has different
penetration enhancers than the reference listed drug cannot be submitted as an ANDA [(i.e., an
abbreviated new drug application)] and, instead, will have to be submitted as an NDA under section
505(b) of the Act. (FDAs August 26, 2009, Response to Auxiliums Citizen Petition)
Partnering Update: Serenity Pharmaceuticals, CPEXs licensing and development partner, continues to
recruit patients in multiple Phase 3 clinical trials of their undisclosed urology drug, which is
delivered
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using CPEXs intranasal technology for the treatment of nocturia. These randomized, double blind,
placebo controlled studies are being conducted at multiple sites in the United States.
New Chief Scientific Officer: On February 1, 2010, CPEX announced the appointment of Nils
Bergenhem, Ph.D. as its Chief Scientific Officer. Prior to joining CPEX, Dr. Bergenhem served as
Chief Scientific Officer at Escoublac, Inc., the first biotechnology company in the Biogen Idec
Innovations Incubator, where he was responsible for development and execution of the research plan
for human osteocalcin in metabolic disease, Type 2 diabetes and obesity. Dr. Bergenhem succeeds
Fred Feldman, Ph.D., who is retiring after a 35 year career in research and drug development.
Management Comments
We are pleased with our progress during 2009, our first full year as a stand-alone company
stated John A. Sedor, CPEX President and Chief Executive Officer. We are enthusiastic about the
recent completion of enrollment in our Phase 2a study of Nasulin and we look forward to finalizing
our analysis and announcing the results. Royalties on sales of Testim are continuing to grow, and
we are encouraged by the continued advancement of Serenitys urology program and the pipeline
opportunities that lie ahead.
About CPEX Pharmaceuticals
CPEX Pharmaceuticals, Inc. is an emerging specialty pharmaceutical company focused on the
development, licensing and commercialization of pharmaceutical products utilizing CPEXs validated
drug delivery platform technology. CPEX has U.S. and international patents and other proprietary
rights to technology that facilitates the absorption of drugs. CPEX has licensed applications of
its proprietary CPE-215® drug delivery technology to Auxilium Pharmaceuticals, Inc.,
which launched Testim®, a topical testosterone gel, in 2003. CPEX also is developing a
proprietary intranasal insulin product candidate, Nasulin, which is currently in Phase 2 clinical
trials. CPEX maintains its headquarters in Exeter, NH. For more information about CPEX, please
visit www.cpexpharm.com.
CPEX began operating as an independent publicly traded company after its spin-off from Bentley
Pharmaceuticals, Inc. (Bentley) on June 30, 2008. The results of operations for the three and
twelve months ended December 31, 2009, the three months ended December 31, 2008 and the balance
sheets as of December 31, 2009 and 2008 represent stand-alone financial information of CPEX. The
financial results reported for the twelve months ended December 31, 2008 (which include six months
before the spin-off) include costs associated with the spin-off transaction and other allocated
expenses of Bentley, the amount of which may differ from the costs associated with operating as an
independent public company. Therefore, the results for the twelve months ended December 31, 2008
are not indicative of the results that might have occurred if CPEX had operated as an independent
public company during the entire period.
Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:
This press release contains forward-looking statements, including, without limitation,
statements regarding the potential activity profile of Nasulin, the prospects for CPEXs
development programs for Nasulin and the timeframe for announcement of results of its Phase 2a
study, the prospects for Serenitys Phase 3 clinical trials for its undisclosed urology drug and
the prospects for growing sales of Testim and the CPEX pipeline. These forward-looking statements
are subject to a number of risks and uncertainties that could cause actual results to differ
materially from future results expressed or implied by such statements. Factors that may cause such
differences include, but are not limited to, risks associated with the following: clinical trials
may not demonstrate the efficacy and safety of CPEX product candidates, regulatory approvals may be
delayed or not obtained at all, competition from other
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products and from the ANDA application of Upsher-Smith, the unpredictability of patent
protection, CPEXs dependence on obtaining agreements with other parties to conduct clinical trials
and commercialize its product candidates that use its drug delivery technology, CPEXs products may
not achieve market acceptance or favorable reimbursement rates from health insurers, intellectual
property litigation, and other uncertainties detailed under Risk Factors in CPEXs Annual Report
on Form 10-K filed with the Securities and Exchange Commission on March 25, 2009. CPEX cautions
investors not to place undue reliance on the forward-looking statements contained in this release.
These statements speak only as of the date of this document, and CPEX undertakes no obligation to
update or revise the statements, except as may be required by law.
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CPEX Pharmaceuticals, Inc. and Subsidiaries
Unaudited Condensed Consolidated and Combined Statements of Operations
Unaudited Condensed Consolidated and Combined Statements of Operations
For the Three Months Ended | For the Twelve Months Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
(in thousands, except per share data) | 2009 | 2008 | 2009 | 2008 | ||||||||||||
Royalties and other revenue |
$ | 5,223 | $ | 4,230 | $ | 18,658 | $ | 15,574 | ||||||||
Operating expenses: |
||||||||||||||||
General and administrative |
2,592 | 1,471 | 8,867 | 6,493 | ||||||||||||
Research and development |
2,968 | 2,341 | 12,291 | 9,119 | ||||||||||||
Separation costs |
| | | 2,502 | ||||||||||||
Depreciation and amortization |
194 | 167 | 699 | 682 | ||||||||||||
Total operating expenses |
5,754 | 3,979 | 21,857 | 18,796 | ||||||||||||
(Loss)income from operations |
(531 | ) | 251 | (3,199 | ) | (3,222 | ) | |||||||||
Other income (expenses): |
||||||||||||||||
Interest income |
34 | 42 | 162 | 312 | ||||||||||||
Interest expense |
(1 | ) | (1 | ) | (3 | ) | (5 | ) | ||||||||
Net (loss) income |
$ | (498 | ) | $ | 292 | $ | (3,040 | ) | $ | (2,915 | ) | |||||
Net (loss) income per common share: |
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Basic and diluted |
$ | (0.20 | ) | $ | 0.12 | $ | (1.21 | ) | $ | (1.25 | ) | |||||
Weighted average common shares
outstanding: |
||||||||||||||||
Basic |
2,535 | 2,466 | 2,511 | 2,338 | ||||||||||||
Diluted |
2,535 | 2,485 | 2,511 | 2,338 | ||||||||||||
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CPEX Pharmaceuticals, Inc. and Subsidiaries
Unaudited Condensed Consolidated Balance Sheets
Unaudited Condensed Consolidated Balance Sheets
December 31, | December 31, | |||||||
(in thousands, except per share data) | 2009 | 2008 | ||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 13,695 | $ | 15,211 | ||||
Receivables |
5,289 | 4,445 | ||||||
Prepaid expenses and other |
593 | 583 | ||||||
Total current assets |
19,577 | 20,239 | ||||||
Non-current assets: |
||||||||
Fixed assets, net |
2,938 | 2,832 | ||||||
Intangible assets, net |
2,211 | 2,394 | ||||||
Restricted cash |
1,000 | 1,000 | ||||||
Other |
317 | 8 | ||||||
Total non-current assets |
6,466 | 6,234 | ||||||
Total assets |
$ | 26,043 | $ | 26,473 | ||||
Liabilities and Stockholders Equity |
||||||||
Current liabilities: |
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Accounts payable |
$ | 1,374 | $ | 1,096 | ||||
Accrued expenses |
1,633 | 1,534 | ||||||
Total current liabilities |
3,007 | 2,630 | ||||||
Commitments and contingencies |
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Stockholders equity: |
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Series A Preferred stock, $0.01 par value, authorized 1,000
shares, issued and outstanding, none |
| | ||||||
Common stock, $0.01 par value, authorized 35,000 shares,
issued and outstanding, 2,537 shares and 2,484, respectively |
25 | 25 | ||||||
Additional paid-in capital |
26,765 | 24,532 | ||||||
Accumulated deficit |
(3,754 | ) | (714 | ) | ||||
Total stockholders equity |
23,036 | 23,843 | ||||||
Total liabilities and stockholders equity |
$ | 26,043 | $ | 26,473 | ||||
# # #
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