BOONTON, N.J.--(BUSINESS WIRE)--Nov. 9, 2009--
Unigene Laboratories, Inc. (OTCBB: UGNE, http://www.unigene.com)
has reported its financial results for the quarter ended September 30,
2009.
Revenue for the three months ended September 30, 2009 was $2,732,000,
compared to $5,084,000 for the three months ended September 30, 2008.
Revenue for both periods primarily consisted of Fortical sales and
royalties, which were $2,398,000 for the three months ended September
30, 2009, and $4,277,000 for the three months ended September 30, 2008.
Fortical royalties were $1,126,000 for the three months ended September
30, 2009, compared to $1,633,000 for the three months ended September
30, 2008. Fortical sales were $1,272,000 for the three months ended
September 30, 2009, compared to $2,645,000 for the three months ended
September 30, 2008. Fortical sales fluctuate each quarter based upon
Upsher-Smith’s ordering schedule. Fortical royalties fluctuate each
quarter based upon the timing, pricing and volume of Upsher-Smith’s
shipments to its customers. Fortical sales and royalties have declined
since the launch of competitive products in December 2008.
Revenue for the nine months ended September 30, 2009 was $10,220,000,
compared to $14,376,000 for the nine months ended September 30, 2008.
Revenue for both periods primarily consisted of Fortical sales and
royalties, which were $8,840,000 for the nine months ended September 30,
2009, and $12,178,000 for the nine months ended September 30, 2008.
Fortical royalties were $3,529,000 for the nine months ended September
30, 2009, compared to $4,246,000 for the nine months ended September 30,
2008. Fortical sales were $5,311,000 for the nine months ended September
30, 2009, compared to $7,932,000 for the nine months ended September 30,
2008.
Total operating expenses were $7,331,000 for the three months ended
September 30, 2009, an increase of $1,969,000 from $5,362,000 for the
three months ended September 30, 2008.
Total operating expenses were $19,420,000 for the nine months ended
September 30, 2009, an increase of $2,353,000 from $17,067,000 for the
nine months ended September 30, 2008. Increases for both periods were
due to the initiation of our oral calcitonin Phase III clinical trial.
Net loss for the three months ended September 30, 2009 was $5,834,000,
or $.06 per share, compared to a net loss of $687,000, or $.01 per
share, for the three months ended September 30, 2008.
Net loss for the nine months ended September 30, 2009 was $12,569,000,
or $.14 per share, compared to a net loss of $3,741,000, or $.04 per
share, for the nine months ended September 30, 2008.
Cash at September 30, 2009 was $4,171,000, a decrease of approximately
$4,412,000 from December 31, 2008. Accounts receivable at September 30,
2009 were $895,000. Neither amount includes the approximately $9,000,000
Unigene received from Tarsa Therapeutics, Inc. (“Tarsa) on October 20,
2009 in association with its oral calcitonin Phase III expenditures.
Although expenses will be reduced due to the elimination of our
expenditures for the oral calcitonin program, further expense reductions
are being considered and we will need additional sources of cash in
order to maintain all of our future operations. Without any reduction in
expenses, we would need additional sources of cash in the first quarter
of 2010.
Following are recent highlights and developments that will be discussed
during Tuesday’s earnings call:
-
In October 2009, we licensed our Phase III oral calcitonin program to
Tarsa, a new company formed by a syndicate of three venture capital
funds specializing in the life sciences: MVM Life Science Partners,
Quaker BioVentures and Novo A/S. Simultaneously, Tarsa announced the
closing of a $24 million Series A financing from the investor
syndicate. Tarsa obtained the worldwide (other than China) rights to
market and sell the oral calcitonin product.
As part of the agreement, Unigene will own approximately 25% of Tarsa on
a fully diluted basis (9,215,000 shares) and will be eligible to receive
milestone and royalty payments. Tarsa will be solely responsible for all
future costs related to the global oral calcitonin program. Tarsa has
paid to Unigene approximately $9,000,000 in association with its oral
calcitonin Phase III expenditures to that date.
-
The global economic recession has impacted the US pharmaceutical
industry, as fewer drugs are being sold, and pharmacy chains,
wholesalers and distributors are reducing and more tightly managing
inventories. As a result, total US pharmaceutical sales in general,
and most osteoporosis products in particular, have declined in 2009.
Since December 2008, total US nasal calcitonin prescriptions have
decreased by approximately 15%. Decreased supply-chain inventories, as
well as decreases in consumer spending, may have contributed to this
result. Despite this challenging environment, data from IMS indicates
that as of August 2009, Fortical® had a 48% share of U.S.
nasal calcitonin prescriptions, down from the 53% April market share.
The decrease in market share is attributable to the December 2008
launch of two products, as well as the June 2009 launch of a 3rd
product, all of which are generic to the innovator product, but not to
Fortical. We do not yet know the long-term effect on Fortical sales
and royalties of the launch of these competing products. However,
certain providers have substituted these products for Fortical,
causing Fortical sales and royalties to decrease. Despite the
availability of these competing products, Fortical still remains the
most frequently prescribed nasal calcitonin product in the U.S.
-
In September 2009, we reported that the U.S. District Court, Southern
District of New York, confirmed the validity of Unigene’s patent on
Fortical® and issued an order permanently enjoining Apotex
Inc. and Apotex Corp. from further infringement of the patent. The
motion for summary judgment filed by the plaintiffs, Unigene and its
licensee Upsher-Smith Laboratories, in the case was granted. Apotex
has indicated that it plans to appeal this decision.
Unigene will host a conference call tomorrow morning, Tuesday, November
10th at 9:00 AM EDT, to discuss its third quarter 2009 financial results
and to provide a Company update. The Company invites all those
interested in hearing management’s discussion to join the call by
dialing (877) 407-0782 for participants in the United States and (201)
689-8567 for international participants.
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UNIGENE LABORATORIES, INC.
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CONDENSED BALANCE SHEETS
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|
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September 30, 2009
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December 31, 2008
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ASSETS
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(Unaudited)
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Current assets:
|
|
|
|
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Cash and cash equivalents
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$
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4,171,288
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$
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8,583,226
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Accounts receivable
|
|
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895,064
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|
|
|
4,635,036
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Inventory, net
|
|
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3,020,234
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|
|
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3,180,019
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Prepaid interest
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|
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101,112
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|
|
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525,000
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Prepaid expenses and other current assets
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4,648,503
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|
|
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1,994,077
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Total current assets
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12,836,201
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18,917,358
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Noncurrent inventory
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3,829,461
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1,649,690
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Property, plant and equipment, net
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3,824,972
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4,023,434
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Patents and other intangibles, net
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|
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2,324,331
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|
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2,064,182
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Investment in joint venture
|
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2,465,981
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|
|
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1,447,418
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Deferred financing costs, net
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319,957
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385,787
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Other assets
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237,610
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|
|
|
153,110
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Total assets
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$
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25,838,513
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$
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28,640,979
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LIABILITIES AND STOCKHOLDERS’ DEFICIT
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Current liabilities:
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Accounts payable
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$
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3,079,654
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$
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708,134
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Accrued expenses
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2,839,336
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|
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2,038,902
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Current portion - deferred licensing fees
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1,416,256
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1,256,756
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Notes payable – Levys
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1,573,752
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--
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Accrued interest
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933,668
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|
|
|
--
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Due to joint venture partner, net of discount of $117,446 in 2009
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1,513,804
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|
|
|
--
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Total current liabilities
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11,356,470
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4,003,792
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Notes payable – Levys, excluding current portion
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14,163,765
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15,737,517
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Note payable–Victory Park–net of discount of $1,551,736 in 2009 and
$1,536,561 in 2008
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17,985,470
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13,463,439
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Accrued interest – principally to Levys, excluding current portion
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|
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2,362,197
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2,094,973
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Accrued expenses, excluding current portion
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277,908
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370,544
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Deferred licensing fees, excluding current portion
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9,765,500
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10,726,069
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Deferred compensation
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|
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422,113
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|
|
|
371,146
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Due to joint venture partner, net of discount of $129,043 in 2008
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--
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|
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845,957
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Total liabilities
|
|
|
56,333,423
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|
|
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47,613,437
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Commitments and contingencies
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Stockholders’ deficit:
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Common Stock - par value $.01 per share, authorized 135,000,000
shares, issued and outstanding:
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90,921,706 shares in 2009 and 90,195,520 shares in 2008
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909,217
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|
|
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901,955
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Additional paid-in capital
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|
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110,497,364
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|
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109,457,677
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Accumulated deficit
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(141,901,491
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)
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(129,332,090
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)
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|
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Total stockholders’ deficit
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(30,494,910
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)
|
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(18,972,458
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)
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Total liabilities and stockholders’ deficit
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|
$
|
25,838,513
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$
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28,640,979
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UNIGENE LABORATORIES, INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
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Three months ended September 30,
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Nine months ended September 30,
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2009
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2008
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2009
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2008
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Revenue:
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Product sales
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$
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1,272,137
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$
|
2,644,567
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|
|
$
|
5,311,291
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$
|
7,931,708
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Royalties
|
|
|
1,125,579
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|
|
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1,632,737
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|
|
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3,529,252
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|
|
|
4,245,962
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|
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Licensing revenue
|
|
|
312,689
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|
|
|
314,187
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|
|
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940,569
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|
|
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942,567
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Development fees and other
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|
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21,359
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|
|
492,329
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438,654
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|
|
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1,255,534
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|
|
|
|
|
|
|
|
|
|
|
|
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2,731,764
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|
|
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5,083,820
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10,219,766
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14,375,771
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Operating expenses:
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Cost of goods sold
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|
478,565
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1,455,684
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1,945,500
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|
|
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4,557,210
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Research, development and facility expenses
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|
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4,808,718
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|
|
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2,170,671
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10,507,692
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6,660,815
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|
General and administrative
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|
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2,043,925
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|
|
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1,735,593
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6,966,747
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|
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5,848,724
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,331,208
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|
|
|
5,361,948
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|
|
|
19,419,939
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|
|
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17,066,749
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|
|
|
|
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Operating loss
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(4,599,444
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)
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(278,128
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)
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(9,200,173
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)
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|
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(2,690,978
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)
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|
|
|
|
|
|
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Other income (expense):
|
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|
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|
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Interest and other income (expense)
|
|
|
29,707
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|
|
|
(4,465
|
)
|
|
|
106,054
|
|
|
|
36,887
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|
|
Interest expense
|
|
|
(1,298,479
|
)
|
|
|
(347,922
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)
|
|
|
(3,525,585
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)
|
|
|
(1,028,286
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)
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|
Loss from investment in joint venture
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|
|
(31,938
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)
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(56,000
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)
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(148,224
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)
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|
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(58,643
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)
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Gain on technology transfer to joint venture
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|
|
66,176
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|
|
|
--
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|
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|
198,527
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|
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|
--
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Loss before income taxes
|
|
|
(5,833,978
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)
|
|
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(686,515
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)
|
|
|
(12,569,401
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)
|
|
|
(3,741,020
|
)
|
|
Income tax expense
|
|
|
--
|
|
|
|
--
|
|
|
|
--
|
|
|
|
--
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|
Net loss
|
|
$
|
(5,833,978
|
)
|
|
$
|
(686,515
|
)
|
|
$
|
(12,569,401
|
)
|
|
$
|
(3,741,020
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share – basic and diluted:
|
|
|
|
|
|
|
|
|
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Net loss per share
|
|
$
|
(0.06
|
)
|
|
$
|
(0.01
|
)
|
|
$
|
(0.14
|
)
|
|
$
|
(0.04
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares outstanding -
|
|
|
|
|
|
|
|
|
|
basic and diluted
|
|
|
90,739,056
|
|
|
|
88,854,264
|
|
|
|
90,394,969
|
|
|
|
88,328,206
|
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About Unigene
Unigene Laboratories, Inc. is a biopharmaceutical company
focusing on the oral and nasal delivery of large-market peptide drugs.
Due to the size of the worldwide osteoporosis market, Unigene is
targeting its initial efforts on developing calcitonin and PTH-based
therapies. Fortical®, Unigene’s nasal calcitonin product for
the treatment of postmenopausal osteoporosis, received FDA approval and
was launched in 2005. Unigene has licensed the U.S. rights for Fortical
to Upsher-Smith Laboratories, worldwide rights for its oral PTH
technology to GlaxoSmithKline, worldwide rights for its calcitonin
manufacturing technology to Novartis and worldwide rights (except for
China) for its oral calcitonin program to Tarsa Therapeutics, Inc.
Unigene’s patented oral delivery technology has successfully delivered,
in preclinical and/or clinical trials, various peptides including
calcitonin, PTH and insulin. Unigene’s patented manufacturing technology
is designed to cost-effectively produce peptides in quantities
sufficient to support their worldwide commercialization as oral or nasal
therapeutics. For more information about Unigene, call (973) 265-1100 or
visit www.unigene.com.
For information about Fortical, visit www.fortical.com.
Safe Harbor statements under the Private Securities Litigation Reform
Act of 1995: This press release contains forward-looking statements
regarding us and our business, financial condition, results of
operations and prospects. Such forward-looking statements include
those which express plans, anticipation, intent, contingency, goals,
targets or future development and/or otherwise are not statements of
historical fact. We have based these forward-looking statements
on our current expectations and projections about future events and they
are subject to risks and uncertainties known and unknown which could
cause actual results and developments to differ materially from those
expressed or implied in such statements. These forward-looking
statements include statements about the following: general
economic and business conditions, our financial condition, competition,
our dependence on other companies to commercialize, manufacture and sell
products using our technologies, the ability of our products to gain
market acceptance and increase market share, the uncertainty of results
of animal and human testing, the risk of product liability and liability
for human trials, our dependence on patents and other proprietary
rights, dependence on key management officials, the availability and
cost of capital, the availability of qualified personnel, changes in, or
the failure to comply with, governmental regulations, the failure to
obtain regulatory approvals for our products and other risk factors
discussed in our Securities and Exchange Commission filings. Words such
as “anticipates,” “expects,” “intends,” “plans,” “predicts,” “believes,”
“seeks,” “estimates,” “may,” “will,” “should,” “would,” “potential,”
“continue,” and variations of these words (or negatives of these words)
or similar expressions, are intended to identify forward-looking
statements. In addition, any statements that refer to expectations,
projections, or other characterizations of future events or
circumstances, including any underlying assumptions, are forward-looking
statements. These forward-looking statements are not guarantees of
future performance and are subject to certain risks, uncertainties, and
assumptions that are difficult to predict. Therefore, our actual results
could differ materially and adversely from those expressed in any
forward-looking statements as a result of various risk factors.
Source: Unigene Laboratories, Inc.
The Investor Relations Group
Investors
Erika Moran/Dian
Griesel, Ph.D.
or
Media
Janet Vasquez
212-825-3210
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