Peregrine Pharmaceuticals Reports Financial Results for Quarter and Fiscal Year Ended April 30, 2017 and Recent Developments
-- Avid Achieves Year-Over-Year Topline Revenue Growth of 30% Exceeding
-- Recent Presentation Supports Bavituximab's Potential to Improve Clinical Outcome for Immune Checkpoint Inhibitors --
"We are very pleased to announce that the business recorded its highest annual revenue to date during fiscal 2017," stated Steven
"We are also continuing to take other important steps to ensure Avid's growth in the coming years. As part of this effort, we have recently installed two new 2,000 liter bioreactors in our Myford facility, and we already have commitments for part of this capacity. Due to its state-of-the-art and modular design, there remains potential to install additional bioreactors in Myford, which will allow us to continue growing the business within our current facilities.
"Turning to the
Peregrine business, we were able to generate some of the most compelling bavituximab data to date, further supporting the combination of bavituximab and checkpoint inhibitors even while reducing R&D spending by over 50% in FY 2017. The clinical findings came from the comprehensive analysis of maturing Phase III SUNRISE data while impressive preclinical results came from our collaborators at
"Both Peregrine and Avid have achieved important milestones in recent quarters. The success of Avid and its continued revenue growth with the compelling data we have seen from the Phase III SUNRISE trial have led us to explore various strategic options that we believe will enable us to enhance stockholder value for all stockholders, including the possible separation of these two distinct businesses."
Research and Development Highlights
"The most compelling data to date from the Phase III SUNRISE trial was presented at AACR and together with the PD-L1 results presented at ASCO this year add to the growing body of data supporting the further development of bavituximab with checkpoint inhibitors," said Joseph Shan, vice president of clinical and regulatory affairs at Peregrine.
In a subgroup analysis, Peregrine researchers looked at the outcome of 91 patients that were enrolled in the Phase III SUNRISE trial that were subsequently treated with anti-PD-1/PD-L1 immune checkpoint inhibitors ("ICI's") post study treatments. The results from this analysis demonstrated that the patients who received docetaxel plus bavituximab (Doc+Bavi) and subsequent ICI had not yet reached median overall survival ("mOS") compared to mOS of 13.0 months for patients who received docetaxel plus placebo (Doc+Placebo) (hazard ratio [HR], 0.43; p=0.005). The statistically significant difference between the two arms in the trial provides strong rationale for combining bavituximab with ICI's and supports the hypothesis that bavituximab may modulate the tumor microenvironment to enhance the anti-tumor activity of ICI's.
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Peregrine researchers presented additional supportive data demonstrating that patients in the bavituximab containing arm who had low baseline PD-L1 expression on tumor cells (i.e., patients typically with poorer response to PD-1/PD-L1 checkpoint inhibitors) lived significantly longer than patients with high baseline PD-L1 expression. These data further support the hypothesis that bavituximab may modulate the tumor microenvironment to complement and enhance the anti-tumor activity of ICI's.
The three clinical trials under the collaboration with the NCCN are advancing as planned.
- Massachusetts General Hospital Cancer Center—Phase I/II Clinical Trial of Bavituximab with Radiation and Temozolomide for Patients with Newly Diagnosed Glioblastoma. This trial is open for enrollment.
- Moffitt Cancer Center—A Phase I Trial of Sorafenib and Bavituximab Plus Stereotactic Body Radiation Therapy for Unresectable Hepatitis C Associated Hepatocellular Carcinoma. This trial is open for enrollment.
The Sidney Kimmel Comprehensive Cancer Centerat Johns Hopkins—Phase II Study of Pembrolizumab and Bavituximab for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck. This trial is expected to be initiated by the end of the calendar year 2017.
The company continues to make progress with its PS exosome diagnostic technology that is designed to detect and monitor cancer. The assay has been successfully optimized and we are currently preparing to generate additional data by testing human samples. Such data will be important to partnering discussions.
Avid Bioservices Highlights
"FY 2017 was a strong year for Avid Bioservices with year-over-year revenue growth of 30% compared to FY 2016. The company recognized revenue of
- The company is providing manufacturing revenue guidance for the full FY 2018 of
$50 million- $55 million.
- Avid's current manufacturing revenue backlog is
$58 million, representing estimated future manufacturing revenue to be recognized under committed contracts. Most of the backlog is expected to be recognized during FY 2018.
Financial Highlights and Results
- During the fourth quarter of FY 2017, we recorded total revenues of
$17,904,000as compared to $18,783,000in the fourth quarter of the prior FY. For FY 2017, we achieved total revenues of $57,630,000as compared to $44,686,000for FY 2016. This represents total revenue growth of 29% for FY 2017 compared to the same prior year period.
- Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services was
$17,904,000for the fourth quarter of FY 2017 compared to $18,783,000 for the fourth quarter of FY 2016. For the year, revenue increased 30% to $57,630,000 for FY 2017 compared to $44,357,000 for FY 2016. The fiscal year increase was primarily attributed to an increase in demand for contract manufacturing services associated with process validation activities. Current committed manufacturing backlog for Avid is approximately $58 million, covering services to be provided during FY 2018 and into FY 2019. Based on this current backlog, Peregrine expects contract manufacturing revenue for FY 2018 to be between $50 and $55 million.
- Total costs and expenses for the fourth quarter of FY 2017 were
$23,208,000, compared to $30,698,000for the fourth quarter of FY 2016. For FY 2017, total costs and expenses were $85,890,000 compared to $101,046,000 for FY 2016. For the fourth quarter of FY 2017, research and development expenses decreased 59% to $6,717,000, compared to $16,265,000for the fourth quarter of FY 2016. For FY 2017, research and development expenses decreased 52% to $28,297,000compared to $59,529,000 for FY 2016.
- Cost of contract manufacturing increased to
$11,782,000in the fourth quarter of FY 2017 compared to $9,721,000for the fourth quarter of FY 2016, and to $38,259,000for the full FY 2017 as compared to $22,966,000for the full FY 2016. These increases are primarily due to an increase in the cost of contract manufacturing associated with higher reported revenue. Also contributing to this increase and impacting gross margins for the period is the higher overhead cost of operating the new Myford facility as well as higher labor cost associated with performing process validation runs combined with lower utilization of available capacity. For the fourth quarter of FY 2017, selling, general and administrative expenses decreased slightly to $4,709,000compared to $4,712,000for FY 2016. For FY 2017 selling, general and administrative expenses increased to $19,334,000compared to $18,551,000 for FY 2016. The full-year increase is primarily due to the company's growing manufacturing business.
- Peregrine's consolidated net loss attributable to common stockholders was
$6,714,000or $0.16per share, for the fourth quarter of FY 2017, compared to a net loss attributable to common stockholders of $13,264,000, or $0.40per share, for the same prior year quarter. For FY 2017, net loss attributable to common stockholders was $32,799,000, or $0.88 per share, compared to $60,136,000, or $1.95 per share, for FY 2016.
- Peregrine reported
$46,799,000in cash and cash equivalents as of April 30, 2017, compared to $61,412,000at fiscal year ended April 30, 2016.
More detailed financial information and analysis may be found in Peregrine's Annual Report on Form 10-K, which will be filed with
Peregrine will host a conference call and webcast this afternoon,
To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the
About Avid Bioservices
Avid Bioservices provides a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 15 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid's services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. For more information about Avid, please visit www.avidbio.com.
Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding
|CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|THREE MONTHS ENDED||TWELVE MONTHS ENDED|
|Contract manufacturing revenue||$||17,904,000||$||18,783,000||$||57,630,000||$||44,357,000|
|COSTS AND EXPENSES:|
|Cost of contract manufacturing||11,782,000||9,721,000||38,259,000||22,966,000|
|Research and development||6,717,000||16,265,000||28,297,000||59,529,000|
|Selling, general and administrative||4,709,000||4,712,000||19,334,000||18,551,000|
|Total costs and expenses||23,208,000||30,698,000||85,890,000||101,046,000|
|LOSS FROM OPERATIONS||(5,304,000||)||(11,915,000||)||(28,260,000||)||(56,360,000||)|
|OTHER INCOME (EXPENSE):|
|Interest and other income||37,000||31,000||108,000||722,000|
|Interest and other expense||(5,000||)||—||(7,000||)||(14,000||)|
|Series E preferred stock accumulated dividends||(1,442,000||)||(1,380,000||)||(4,640,000||)||(4,484,000||)|
|NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS||$||(6,714,000|
|WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:|
|Basic and Diluted (1)||42,141,720||33,478,863||37,109,493||30,895,089|
|BASIC AND DILUTED LOSS PER COMMON SHARE (1)||$||(0.16||)||$||(0.40||)||$||(0.88||)||$||(1.95||)|
(1) All share and per share amounts of our common stock issued and outstanding for all periods have been retroactively adjusted to reflect the one-for-seven reverse stock split which took effect with the opening of
|CONSOLIDATED BALANCE SHEETS|
|AS OF |
|Cash and cash equivalents||$||46,799,000||$||61,412,000|
|Trade and other receivables||7,742,000||2,859,000|
|Total current assets||89,100,000||81,808,000|
|PROPERTY AND EQUIPMENT:|
|Furniture, fixtures, office equipment and software||4,499,000||4,045,000|
|Less accumulated depreciation and amortization||(11,700,000||)||(9,610,000||)|
|Property and equipment, net||23,674,000||24,302,000|
|CONSOLIDATED BALANCE SHEETS|
|AS OF |
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued clinical trial and related fees||4,558,000||7,594,000|
|Accrued payroll and related costs||6,084,000||5,821,000|
|Other current liabilities||993,000||1,488,000|
|Total current liabilities||62,931,000||57,574,000|
|Deferred rent, less current portion||1,599,000||1,395,000|
|Commitments and contingencies|
|STOCKHOLDERS' EQUITY (1):|
|Preferred stock - |
issued and outstanding - 1,647,760 and 1,577,440, respectively
|Common stock - |
shares; issued and outstanding - 44,014,040 and 33,847,213,
|Total stockholders' equity||53,582,000||50,074,000|
|TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY||$||118,112,000||$||109,043,000|
(1) All share and per share amounts of our common stock issued and outstanding for all periods have been retroactively adjusted to reflect the one-for-seven reverse stock split which took effect with the opening of trading on
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Stephanie Diaz(Investors) Vida Strategic Partners 415-675-7401 firstname.lastname@example.org Tim Brons(Media) Vida Strategic Partners415-675-7402 email@example.com
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