Message #29 From:
NewsBot Date: March 19, 2007 05:00:00 AM
UGNE News Unigene Announces Financial Results for Fourth Quarter and Year-End 2006
FAIRFIELD, N.J.--(BUSINESS WIRE)--Unigene Laboratories, Inc. (OTCBB: UGNE) announced its financial results for December 31, 2006.
Revenue for the three months ended December 31, 2006, was $3,415,000 compared to $1,600,000 for the three months ended December 31, 2005, and $6,059,000 for the year ended December 31, 2006, compared to $14,276,000 for the year ended December 31, 2005. Revenue for all periods is primarily due to Fortical. Revenue from Fortical sales and royalties were $3,217,000 for the three months ended December 31, 2006, $1,510,000 for the three months ended September 30, 2006; $348,000 for the three months ended June 30, 2006 and $197,000 for the three months ended March 31, 2006.
Fortical royalties were $1,232,000 and $606,000 for the three months ended December 31, 2006 and 2005, respectively and $2,451,000 and $2,613,000 for the year ended December 31, 2006 and 2005, respectively. Fortical sales were $1,984,000 and $2,822,000, for the three months and year ended December 31, 2006, respectively. Fortical sales were $804,000 and $6,479,000 for the three months and year ended December 31, 2005, respectively.
Our net loss for the three months ended December 31, 2006, was $3,025,000, or $.03 per share, compared to a net loss of $2,653,000, or $.03 per share for the three months ended December 31, 2005. The three months ended December 31, 2006, includes $233,000 in expenses for non-cash stock option compensation.
Our net loss for the year ended December 31, 2006, was $11,784,000 or $.14 per share, compared to a net loss of $496,000, or $.01 per share, for the year ended December 31, 2005. The year ended December 31, 2006, includes $794,000 in expenses for non-cash stock option compensation, as well as an additional $331,000 in non-cash expenses related to our deferred compensation plan. As of December 31, 2006, we have approximately $1,000,000 in expenses for non-cash stock option compensation that remains to be recognized, primarily in 2007.
Total operating expenses were $6,599,000 for the three months ended December 31, 2006, an increase from $4,301,000 for the three months ended December 31, 2005.
Total operating expenses were $17,039,000 for the year ended December 31, 2006, an increase from $13,681,000 for the year ended December 31, 2005.
Our cash balance at December 31, 2006 was $3,357,000, a decrease of approximately $789,000 from December 31, 2005.
“The doubling of revenues for the fourth quarter of 2006, as compared to the third quarter, confirms that the process of “pull through” for Fortical® is complete,” commented Dr. Warren Levy, President and CEO. “In combination with recent prescription trends, this suggests a positive direction for future revenues.”
Following are highlights of 2006 accomplishments and new developments:
According to NDC, prescriptions for Fortical, the Company’s first U.S. product that was launched in August 2005, grew to almost 83,000 units in January, 2007, reflecting 36% growth since December and a 35% market share.
According to IMS, total weekly prescriptions exceeded 20,000 for the week ending March 2nd for the first time in the product’s history.
Total prescriptions have grown 62% in the 10 weeks ended March 2nd while new prescriptions increased more than 108% during the same period.
The Company has recently reported $8 million in expected payments from its partner Novartis. In February 2007, Nordic Bioscience, the development partner of Novartis, initiated a Phase III clinical study for osteoporosis with oral calcitonin, triggering a $5.5 million milestone payment. In January 2007, Unigene and Novartis entered into a new $2.5 million supply agreement with Novartis for a second osteoporosis peptide.
Our first clinical studies in China have been completed, and reports are being compiled in preparation for a meeting with the Chinese regulatory authorities to discuss registration of the injectable form of the product.
In February 2007, Unigene was awarded a $900,000 SBIR grant from a division of the NIH to fund the continuation of the Company’s proprietary program to identify novel therapeutic peptide hormones. If successful, this could lead to significant strengthening of Unigene’s already considerable intellectual property position.
In November 2006, we engaged leading clinicians from Johns Hopkins Medical School to consult on the Company’s Site-Directed Bone Growth (SDBG) program. At the same time, Unigene acquired the rights to three patent applications involving the use of equipment and procedures to expand our patent position. Although the research program is at an early stage, it may find application for the prevention and treatment of vertebral compression fractures, the prevention and treatment of hip fractures, the treatment of certain long bone fractures and possibly even the treatment of chronic back pain. According to a marketing consulting group, the number of Americans who had such medical procedures last year, or would have been candidates for the SDBG procedure had it been available, totaled 6.5 million potential patients. The Company plans to develop additional animal and possibly human data in 2007.
In March 2006, Unigene successfully completed a private placement, raising $13 million from an institutional investor.
When the Company’s financial position permits, we intend to pay back related-party debt and eliminate the going concern uncertainty, to allow for listing of the common stock on a national exchange.
UNIGENE LABORATORIES, INC.
BALANCE SHEETS
DECEMBER 31, 2006 and 2005
2006
2005
ASSETS
Current assets:
Cash and cash equivalents
$
3,357,351
$
4,146,486
Accounts and other receivable
1,240,114
661,467
Prepaid expenses
303,444
288,789
Inventory
5,283,000
4,181,210
Total current assets
10,183,909
9,277,952
Property, plant and equipment, net
2,364,141
2,075,459
Patents and other intangibles, net
1,438,848
1,376,318
Investment in joint venture
30,545
33,885
Other assets
33,879
10,388
Total assets
$
14,051,322
$
12,774,002
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable
$
884,958
$
756,004
Accrued expenses - other
1,806,707
2,011,687
Current portion - deferred licensing fees
762,752
756,752
Notes payable - stockholders
8,105,000
10,105,000
Accrued interest – stockholders
8,081,180
6,549,215
Current portion - capital lease obligations
70,780
73,429
Total current liabilities
19,711,377
20,252,087
Deferred licensing fees, excluding current portion
8,156,262
8,913,021
Capital lease obligations, excluding current portion
40,880
115,522
Deferred compensation
330,643
-
Total liabilities
28,239,162
29,280,630
Commitments and contingencies
Stockholders’ deficit:
Common Stock - par value $.01 per share, authorized 135,000,000 shares; issued and outstanding: 87,731,015 shares in 2006 and 83,201,515 shares in 2005.
877,310
832,015
Additional paid-in capital
104,740,178
90,682,549
Accumulated deficit
(119,805,328)
(108,021,192)
Total stockholders’ deficit
(14,187,840)
(16,506,628)
Total liabilities and stockholders’ deficit
$
14,051,322
$
12,774,002
UNIGENE LABORATORIES, INC.
STATEMENTS OF OPERATIONS
Years Ended December 31, 2006, 2005 and 2004
2006
2005
2004
Revenue:
Licensing revenue
$
756,759
$
4,756,753
$
4,610,919
Product sales
2,829,678
6,836,524
3,329,884
Royalties
2,450,531
2,613,364
-
Development services
-
11,729
354,006
Other
21,964
57,180
105,233
6,058,932
14,275,550
8,400,042
Operating expenses:
Research, development and facility expenses
8,567,452
6,034,343
7,895,725
Cost of goods sold
1,752,680
1,448,472
2,526,608
General and administrative
6,422,693
4,639,638
3,077,344
Inventory reserve
296,266
1,558,689
244,824
17,039,091
13,681,142
13,744,501
Operating income (loss)
(10,980,159)
594,408
(5,344,459)
Other income (expense):
Gain on the extinguishment of debt and related interest
-
-
286,466
Interest income
265,489
32,799
38,155
Interest expense-principally to stockholders
(1,598,265)
(1,542,711)
(1,406,967)
Loss before income taxes
(12,312,935)
(915,504)
(6,426,805)
Income tax benefit – principally from sale of New Jersey tax benefits
