TUSTIN, Calif., Sept. 3 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today announced financial results for the first quarter of fiscal year (FY) 2010 ended July 31, 2009. Total revenues for the first quarter of FY 2010 increased 345% to $6,750,000, compared to $1,517,000 for the comparable prior year quarter. This increase was primarily generated from increased government contract revenue and from increased sales by Avid Bioservices, the company's wholly owned contract manufacturing subsidiary.
Avid generated manufacturing revenues of $2,070,000 for the first quarter of FY 2010, compared to $1,193,000 for the comparable prior year quarter, an increase of 74%. The increase in Avid revenues reflects increased manufacturing services provided to third-party customers during the quarter. In addition to manufacturing revenues, Peregrine generated revenues from services provided under its contract with the U.S. Defense Threat Reduction Agency for the Transformational Medical Technologies Initiative (TMTI) to evaluate bavituximab as a potential broad-spectrum treatment for viral hemorrhagic fever infections. Government contract revenues were $4,671,000 for the first quarter of FY 2010, compared to $324,000 for the prior year quarter when the government contract work had just begun.
Total costs and expenses in the first quarter of FY 2010 were $8,940,000, compared to $6,677,000 in the first quarter of FY 2009, an increase of 34%. Costs of contract manufacturing, which increased to $1,073,000 in the first quarter of FY 2010 from $903,000 in the prior year quarter, were directly driven by the increase in Avid revenue. Research and development (R&D) expenses increased to $6,074,000 in the first quarter of FY 2010, compared to $4,068,000 in the prior year quarter, an increase of 49%, primarily due to increased R&D costs incurred under the government contract combined with increased costs associated with the advancement of Peregrine's clinical programs. Selling, general, and administrative (SG&A) expenses increased only slightly in the first quarter of FY 2010 to $1,793,000, compared to $1,706,000 in the first quarter of FY 2009.
The consolidated net loss of $2,428,000 or $0.01 per basic and diluted share in the first quarter of FY 2010 represented a 52% decrease compared to the consolidated net loss of $5,086,000, or $0.02 per basic and diluted share for the same prior year period. At July 31, 2009, the company had $12,778,000 in cash and cash equivalents.
"I am pleased to report that the momentum we achieved in all elements of our business in the last fiscal year has continued into fiscal year 2010," said Steven W. King, president and CEO of Peregrine. "We have continued to successfully advance the bavituximab and Cotara cancer clinical trials that are the key value drivers for Peregrine. Since the start of the new fiscal year, we completed patient enrollment in two bavituximab clinical trials and presented positive interim data from both studies at ASCO, in addition to reporting positive clinical data from our ongoing Cotara clinical studies at the Society of Nuclear Medicine 2009 Annual Meeting. We also continued to make excellent progress in our work under our TMTI government research contract worth up to $44.4 million to develop bavituximab for the treatment of viral hemorrhagic fevers (VHF), while our collaborators at UT Southwestern Medical Center were awarded a significant grant from the National Institute for Allergies and Infectious Diseases (NIAID) for an expanded study of additional PS-targeting antibodies as potential treatments for VHF. The awarding of the new NIAID contract is another important outside validation of the broad-spectrum anti-viral potential of our PS-targeting technology platform."
Mr. King added, "In all three of our bavituximab cancer Phase II trials, bavituximab in combination with chemotherapy has demonstrated encouraging signs of anti-tumor activity in patients with advanced breast and lung cancers. All three trials surpassed the requisite efficacy criteria for expansion of patient enrollment. These trials, along with recent completion of planned enrollment in our U.S. Phase I bavituximab cancer study, are helping to set the stage for advancing bavituximab toward additional clinical trials. As we plan for these trials, we are very pleased to be working with noted cancer clinical researcher Dr. Bruce Chabner, clinical director of Massachusetts General Hospital Cancer Center, who is serving as a clinical advisor on the design of these next clinical trials."
Mr. King continued, "During the first quarter, we completed an agreement with Affitech A/S, sublicensing them certain rights to develop the selective anti-VEGF antibodies produced in an earlier collaboration. This agreement provides us with upfront and potential milestone payments and royalties, and is an excellent example of how we intend to continue leveraging the non-core technologies that are part of Peregrine's asset base. We also reported outstanding financial results for the quarter, growing revenues 345% and reducing our net loss by more than half. Our revenue growth reflects the success of our federal government R&D contract work and continued growth in our contract manufacturing business, Avid. We announced last week that we have expanded the management team at Avid to help manage and sustain this growth."
Mr. King concluded, "These achievements since the end of the last fiscal year have enabled us to continue to build significant value in our oncology clinical pipeline, to grow the value of our contract manufacturing business and to realize immediate value from our bavituximab anti-viral platform through our TMTI government contract work. Planning for the exciting next phase of our bavituximab oncology program has already begun. With seven ongoing clinical trials on track to generate additional data in the coming months, Avid Bioservices focused on continued growth and our government-supported anti-viral research contract proceeding well, we believe Peregrine is well positioned to continue building the momentum we have achieved in the first quarter of this new fiscal year."
FY 2010 Highlights to Date
Bavituximab Anti-Cancer Program
Peregrine reported progress in all four ongoing trials in its bavituximab cancer program, including its three Phase II trials:
Bavituximab Anti-Viral Program
The company continued to advance the bavituximab anti-viral program:
Cotara((R)) Brain Cancer Program
The company will host a conference call today, September 3, 2009 at 11:30 a.m. EDT/8:30 a.m. PDT to discuss its First Quarter FY 2010 financial results.
To listen to a live broadcast of the call over the Internet or to review the archived call, please visit: www.peregrineinc.com. The webcast will be archived on Peregrine's website for approximately 30 days.
To listen to the conference call via telephone, please call the following number approximately 10 minutes prior to the scheduled start time and request to join the Peregrine Pharmaceuticals call: (800) 860-2442. A telephonic replay of the conference call will be available starting approximately one hour after the conclusion of the call through September 10, 2009 by calling (877) 344-7529, passcode 431883#.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections. The company is pursuing three separate clinical programs in cancer and hepatitis C virus infection with its lead product candidates bavituximab and Cotara((R)). Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at www.peregrineinc.com.
Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to the risk that the company may experience delays in clinical trial patient enrollment, the results of future clinical trials may not correlate with the results from prior clinical and preclinical studies, the risk that the rate of objective tumor response for the expansion stages of the company's three Phase II trials will not be consistent with the objective tumor responses experienced in the first stage of the respective Phase II trials, the risk that the standard chemotherapy response rate will not be improved as a result of the combination therapy with the inclusion of bavituximab, the risk that the company will not be able to raise additional capital under its "At the Market" sales agreement, the risk that Avid's revenue growth may slow or decline, the risk that Avid may experience technical difficulties in processing customer orders which could delay delivery of products to customers and receipt of payment, the risk that one or more existing Avid customers terminates its contract prior to completion, the risk that the company does not receive all of its funding under the DTRA contract, the risk that future protocol submissions may not be approved and the risk that the company may not be able to monetize any of its assets. It is important to note that the company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in the Company's SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2009. The company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.
Contacts: GendeLLindheim BioCom Partners Investors Media email@example.com Jennifer Anderson (800) 987-8256 (212) 918-4642
-financial tables to follow-
PEREGRINE PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS JULY 31, APRIL 30, 2009 2009 ---- ---- Unaudited ASSETS CURRENT ASSETS: Cash and cash equivalents $12,778,000 $10,018,000 Trade and other receivables 1,715,000 1,770,000 Government contract receivables 1,449,000 1,944,000 Inventories, net 6,177,000 4,707,000 Debt issuance costs, current portion 202,000 229,000 Prepaid expenses and other current assets, net 991,000 1,466,000 ------- --------- Total current assets 23,312,000 20,134,000 PROPERTY: Leasehold improvements 675,000 675,000 Laboratory equipment 4,189,000 4,180,000 Furniture, fixtures and office equipment 902,000 902,000 ------- ------- 5,766,000 5,757,000 Less accumulated depreciation and amortization (4,192,000) (4,076,000) ---------- ---------- Property, net 1,574,000 1,681,000 OTHER ASSETS: Debt issuance costs, less current portion 102,000 142,000 Other assets 1,225,000 1,170,000 --------- --------- Total other assets 1,327,000 1,312,000 TOTAL ASSETS $26,213,000 $23,127,000 =========== =========== PEREGRINE PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (continued) JULY 31, APRIL 30, 2009 2009 ---- ---- Unaudited LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable $3,395,000 $3,518,000 Accrued clinical trial site fees 773,000 955,000 Accrued legal and accounting fees 519,000 667,000 Accrued royalties and license fees 170,000 182,000 Accrued payroll and related costs 1,735,000 1,580,000 Notes payable, current portion and net of discount 1,822,000 1,465,000 Deferred revenue 5,755,000 3,776,000 Deferred government contract revenue 2,332,000 3,871,000 Customer deposits 966,000 2,287,000 Other current liabilities 625,000 563,000 ------- ------- Total current liabilities 18,092,000 18,864,000 Notes payable, less current portion and net of discount 2,743,000 3,208,000 Other long-term liabilities 153,000 154,000 Commitments and contingencies STOCKHOLDERS' EQUITY: Preferred stock-$0.001 par value; authorized 5,000,000 shares; non-voting; nil shares outstanding - - Common stock-$0.001 par value; authorized 325,000,000 shares; outstanding - 236,968,914 and 227,688,555, respectively 237,000 227,000 Additional paid-in capital 254,776,000 248,034,000 Accumulated deficit (249,788,000) (247,360,000) ------------- ------------ Total stockholders' equity 5,225,000 901,000 --------- ------- TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $26,213,000 $23,127,000 =========== =========== PEREGRINE PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS THREE MONTHS ENDED ------------------ July 31, 2009 July 31, 2008 ------------- ------------- Unaudited Unaudited REVENUES: Contract manufacturing revenue $2,070,000 $1,193,000 Government contract revenue 4,671,000 324,000 License revenue 9,000 - ----- --- Total revenues 6,750,000 1,517,000 COSTS AND EXPENSES: Cost of contract manufacturing 1,073,000 903,000 Research and development 6,074,000 4,068,000 Selling, general and administrative 1,793,000 1,706,000 --------- --------- Total costs and expenses 8,940,000 6,677,000 --------- --------- LOSS FROM OPERATIONS (2,190,000) (5,160,000) ---------- ---------- OTHER INCOME (EXPENSE): Interest and other income 40,000 75,000 Interest and other expense (278,000) (1,000) -------- ------ NET LOSS $(2,428,000) $(5,086,000) =========== =========== WEIGHTED AVERAGE COMMON SHARES OUTSTANDING 234,043,957 226,210,617 =========== =========== BASIC AND DILUTED LOSS PER COMMON SHARE $(0.01) $(0.02) ====== ======
|SOURCE Peregrine Pharmaceuticals, Inc.|
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