Peregrine Pharmaceuticals Reports Financial Results for Quarter and Fiscal Year Ended April 30, 2016 and Recent Developments
-- Avid Contract Manufacturing Revenues Increased 66% to
-- Growing Biomanufacturing Demand Prompts Plans for Third Manufacturing Facility Expected to be Commissioned by mid-2017 --
-- Analysis of Data from SUNRISE Phase III Trial Ongoing with New Clinical Trials Expected to Commence Late 2016 to Early 2017 --
-- Novel PS-Exosome Technology In-Licensed for Cancer Detection and Monitoring --
Highlights Since
"Peregrine's business strategy is to focus the company's resources primarily on continuing to grow its biomanufacturing business while advancing R&D efforts through small, proof of concept clinical trials and the development of new technologies. Together, this will allow Peregrine to reach profitability, increase shareholder value by steadily increasing the worth of the company's established CDMO business, and retain significant upside potential from bavituximab and other R&D programs," stated
Avid Bioservices Highlights
"The company's manufacturing business has experienced substantial revenue growth over the past several fiscal years with a five-year compounded annual growth rate of 39% and year-over-year
growth of 66%. In addition, this revenue growth came entirely from Avid's first manufacturing facility and the company is positioned for continued revenue growth with the launch of its second manufacturing facility that became fully operational in March 2016," stated
- On
June 2, 2016 , the company announced the goal of achieving overall future sustained profitability in 24 months.
- The company is projecting manufacturing revenue for FY 2017 of
$50 -$55 million .
- Avid's current manufacturing revenue backlog is
$68 million , representing estimated future manufacturing revenue to be recognized under committed contracts. This backlog covers revenue to be recognized in fiscal year 2017 and into fiscal year 2018.
- In
March 2016 , the company formally commissioned its new, state-of-the-art biomanufacturing facility (Myford facility). The Myford facility is designed to utilize the most cutting-edge, single-use equipment to accommodate a fully disposable biomanufacturing process for late Phase III clinical and commercial production of biologics. The facility was designed to operate in commercial campaign mode whereby multiple bioreactors are simultaneously in operation, which more than doubles the facility's manufacturing capacity.
- The recently commissioned
Myford facility has completed an initial process validation campaign with a second process validation underway and two more planned for later this year.
- In response to demand for manufacturing services, the company is now designing a third manufacturing facility dedicated to clinical manufacturing that is anticipated to significantly increase Avid's manufacturing capacity. The new clinical suite is expected to be complete and ready for clinical manufacturing activities by mid-2017.
Clinical Development Highlights
- SUNRISE Phase III Trial - Peregrine is currently conducting an extensive review and analysis of the available clinical data and testing the numerous collected biomarker samples in order to determine if certain subgroups or patients with other characteristics benefited more from bavituximab
treatment. The company believes such information could be critical in helping guide the bavituximab clinical program including its collaborations with the National Comprehensive Cancer Network (NCCN), AstraZeneca, and other clinical collaborators.
- Going forward, Peregrine's clinical development strategy is to focus on small, early stage proof of concept trials with other immune stimulating therapies. The intent behind this strategy is to control research and development costs, while continuing to generate clinical data to further validate bavituximab's combination potential that will be critical to bringing onboard a partner to help advance the program.
- As part of this clinical strategy, Peregrine's research collaboration with the NCCN is advancing as planned. The purpose of this collaboration is to expand the company's ongoing clinical research and development of bavituximab for the treatment of a range of tumors. Selected trials are expected to be initiated by the end of calendar 2016, or early 2017.
Exosome Program
- Peregrine in-licensed a novel exosome technology from the UT Southwestern that has potential for cancer detection and monitoring applications.
- This technology aligns directly with the company's expertise, its proprietary PS-targeting platform and the bavituximab development program. As such, there are opportunities to use this technology as both a complementary tool in bavituximab's ongoing development, as well as more broadly as the basis for novel cancer detection and monitoring tests that can be the focus of partnering efforts.
- The licensed technology is designed to detect PS-positive exosomes within the
blood. These exosomes are highly immunosuppressive, which is consistent with the immunosuppression that is often seen in tumor microenvironments.
- Preliminary studies have provided evidence that the levels of PS-positive exosomes present in the blood of cancer patients are higher than levels found in the blood of healthy volunteers. Furthermore, study findings also suggest that there is a correlation between the level of PS-positive exosomes detected in the blood of cancer patients and the severity of disease burden.
- Peregrine has the existing infrastructure, staff and expertise to develop, optimize and validate testing methodologies for detecting PS-positive exosomes in blood samples. The company expects to secure a partner to develop the final commercial test kit.
- This technology aligns directly with the company's expertise, its proprietary PS-targeting platform and the bavituximab development program. As such, there are opportunities to use this technology as both a complementary tool in bavituximab's ongoing development, as well as more broadly as the basis for novel cancer detection and monitoring tests that can be the focus of partnering efforts.
Supportive Research Highlights
- Peregrine plans to continue conducting pre-clinical and translational studies to support ongoing and future clinical development activities. The goal of these studies will be to generate compelling translational biomarker data that inform the selection of treatment combinations featuring bavituximab. The company believes that data from these studies will be important for partnering bavituximab.
- Positive results presented at the 2016
American Association for Cancer Research (AACR) Annual Meeting provided further support for Peregrine's strategy of evaluating bavituximab in combination with a range of novel immuno-oncology (I-O) agents for the treatment of various cancers. The presentation of preclinical study data demonstrated enhanced anti-tumor activity and immune activation for a combination of the preclinical bavituximab equivalent (ch1N11) and anti-PD-1 therapy in models of breast cancer, including triple negative breast cancer (TNBC).
- Positive results presented at the 2016
Financial Results
Total revenues for the fourth quarter FY 2016 were
Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services provided to its third-party clients increased 102% to
Total costs and expenses for the fourth quarter of FY 2016 were
Peregrine's consolidated net loss attributable to common stockholders was
Peregrine reported
More detailed financial information and analysis may be found in Peregrine's Annual Report on Form 10-K, which will be filed with the
Conference Call
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
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 BALANCE SHEETS | |||||||
| AS OF | |||||||
| 2016 | 2015 | ||||||
| ASSETS | |||||||
| CURRENT ASSETS: | |||||||
| Cash and cash equivalents | $ | 61,412,000 | $ | 68,001,000 | |||
| Trade and other receivables, net | 2,859,000 | 3,813,000 | |||||
| Inventories | 16,186,000 | 7,354,000 | |||||
| Prepaid expenses and other current assets, net | 1,351,000 | 1,355,000 | |||||
| Total current assets | 81,808,000 | 80,523,000 | |||||
| PROPERTY AND EQUIPMENT: | |||||||
| Leasehold improvements | 19,610,000 | 1,538,000 | |||||
| Laboratory equipment | 10,257,000 | 5,965,000 | |||||
| Furniture, fixtures, office equipment and software | 4,045,000 | 3,991,000 | |||||
| Construction-in-progress | - | 11,819,000 | |||||
| 33,912,000 | 23,313,000 | ||||||
| Less accumulated depreciation and amortization | (9,610,000 | ) | (8,189,000 | ) | |||
| Property and equipment, net | 24,302,000 | 15,124,000 | |||||
| Restricted cash | 600,000 | - | |||||
| Other assets | 2,333,000 | 1,817,000 | |||||
| TOTAL ASSETS | $ | 109,043,000 | $ | 97,464,000 | |||
| CONSOLIDATED BALANCE SHEETS | |||||||
| AS OF | |||||||
| 2016 | 2015 | ||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
| CURRENT LIABILITIES: | |||||||
| Accounts payable | $ | 8,429,000 | $ | 10,385,000 | |||
| Accrued clinical trial and related fees | 7,594,000 | 3,910,000 | |||||
| Accrued payroll and related costs | 5,821,000 | 4,606,000 | |||||
| Deferred revenue | 10,030,000 | 6,630,000 | |||||
| Customer deposits | 24,212,000 | 11,363,000 | |||||
| Other current liabilities | 1,488,000 | 437,000 | |||||
| Total current liabilities | 57,574,000 | 37,331,000 | |||||
| Deferred rent, less current portion | 1,395,000 | 1,098,000 | |||||
| Commitments and contingencies | |||||||
| STOCKHOLDERS' EQUITY: | |||||||
| Preferred stock - issued and outstanding - 1,577,440 and 1,574,764, respectively | 2,000 | 2,000 | |||||
| Common stock - shares; issued and outstanding - 236,930,485 and 193,346,627, respectively | 237,000 | 193,000 | |||||
| Additional paid-in-capital | 559,111,000 | 512,464,000 | |||||
| Accumulated deficit | (509,276,000 | ) | (453,624,000 | ) | |||
| Total stockholders' equity | 50,074,000 | 59,035,000 | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 109,043,000 | $ | 97,464,000 | |||
| CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||||
| FOR EACH OF THE THREE YEARS IN THE PERIOD ENDED | |||||||||||
| 2016 | 2015 | 2014 | |||||||||
| REVENUES: | |||||||||||
| Contract manufacturing revenue | $ | 44,357,000 | $ | 26,744,000 | $ | 22,294,000 | |||||
| License revenue | 329,000 | 37,000 | 107,000 | ||||||||
| Total revenues | 44,686,000 | 26,781,000 | 22,401,000 | ||||||||
| COSTS AND EXPENSES: | |||||||||||
| Cost of contract manufacturing | 22,966,000 | 15,593,000 | 13,110,000 | ||||||||
| Research and development | 59,529,000 | 42,996,000 | 27,723,000 | ||||||||
| Selling, general and administrative | 18,551,000 | 18,691,000 | 17,274,000 | ||||||||
| Total costs and expenses | 101,046,000 | 77,280,000 | 58,107,000 | ||||||||
| LOSS FROM OPERATIONS | (56,360,000 | ) | (50,499,000 | ) | (35,706,000 | ) | |||||
| OTHER INCOME (EXPENSE): | |||||||||||
| Interest and other income | 722,000 | 142,000 | 349,000 | ||||||||
| Interest and other expense | (14,000 | ) | (1,000 | ) | (5,000 | ) | |||||
| NET LOSS | $ | (55,652,000 | ) | $ | (50,358,000 | ) | $ | (35,362,000 | ) | ||
| COMPREHENSIVE LOSS | $ | (55,652,000 | ) | $ | (50,358,000 | ) | $ | (35,362,000 | ) | ||
| Series E preferred stock accumulated dividends |
(4,484,000 | ) | (3,696,000 | ) | (401,000 | ) | |||||
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | (60,136,000 | ) | $ | (54,054,000 | ) | $ | (35,763,000 | ) | ||
| WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: | |||||||||||
| Basic and Diluted | 216,265,620 | 182,558,332 | 161,579,649 | ||||||||
| BASIC AND DILUTED LOSS
PER COMMON SHARE | $ | (0.28 | ) | $ | (0.30 | ) | $ | (0.22 | ) | ||
Contacts:Jay Carlson Peregrine Pharmaceuticals, Inc. (800) 987-8256 info@peregrineinc.comStephanie Diaz (Investors)Vida Strategic Partners 415-675-7401 sdiaz@vidasp.comTim Brons (Media)Vida Strategic Partners 415-675-7402 tbrons@vidasp.com
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