Peregrine Pharmaceuticals Reports Financial Results for Third Quarter of Fiscal Year 2016 and Recent Developments
--Company Focused on Advancing Its Bavituximab Immuno-Oncology Program Through Its Pharmaceutical, Academic and Clinical Collaborations--
--Full Fiscal Year 2016 Revenue From Biomanufacturing Business, Avid Bioservices, Expected to Top
--New State-of-the-Art Production Facility Commissioned and Ready for GMP Manufacturing Expands Revenue Potential--
Highlights Since
"Earlier this week, we announced the commissioning of our new commercial biomanufacturing facility, which gives us significant revenue growth potential over the short term. This represented a key corporate milestone and we are continuing to evaluate a number of additional opportunities to further expand this important, revenue-generating business," stated
Clinical Development Highlights
- Peregrine is working closely with its collaborators and key opinion leaders ("KOLs") to transition the company's clinical program to focus on bavituximab combinations with I-O agents. Peregrine's partners and advisors, including AstraZeneca,
Memorial Sloan Kettering Cancer Center , the National Comprehensive Cancer Network® (NCCN®) and theUniversity of Texas , Southwestern, are leaders in the field of immuno-oncology, and their collective guidance will play an important role in the program. Activities in this area include:
- Peregrine and AstraZeneca are currently evaluating the trial designs for the two previously announced clinical trials combining bavituximab with AstraZeneca's PD-L1 inhibitor, durvalumab. In light of the recent development in the SUNRISE trial, the companies are currently working together to identify the optimal path forward for demonstrating potential mechanistic synergies between bavituximab and durvalumab in different patient populations. The expected timing of initiation of any trial will be determined upon finalization of its trial design.
- Peregrine entered into a new research collaboration with the NCCN to expand upon the company's clinical development program of bavituximab in combination with immuno-oncology agents for the treatment of a range of
tumors. NCCN is a not-for-profit alliance of 26 of the world's leading cancer centers dedicated to improving the quality, effectiveness, and efficiency of cancer care. Peregrine will fund multiple investigator-initiated clinical and correlative studies with bavituximab in multiple cancers at NCCN Member Institutions and their affiliate community hospitals through a
$2 million research grant to NCCN's Oncology Research Program (ORP). NCCN will be responsible for oversight and monitoring of the clinical studies through the research grant.
- Peregrine and AstraZeneca are currently evaluating the trial designs for the two previously announced clinical trials combining bavituximab with AstraZeneca's PD-L1 inhibitor, durvalumab. In light of the recent development in the SUNRISE trial, the companies are currently working together to identify the optimal path forward for demonstrating potential mechanistic synergies between bavituximab and durvalumab in different patient populations. The expected timing of initiation of any trial will be determined upon finalization of its trial design.
Supportive Research Highlights
- Positive results were presented at the 2015 annual meeting of the
Society for Immunotherapy of Cancer (SITC) from multiple new preclinical studies demonstrating enhanced anti-tumor activity and immune activation for combinations of a preclinical bavituximab equivalent and checkpoint inhibitors such as anti-PD-1 and anti-CTLA-4 in preclinical models of breast cancer and melanoma. Additionally, the company announced preliminary results for a new clinical test specifically designed to illustrate how bavituximab modulates immune responses in the tumor microenvironment.
Avid Bioservices Highlights
"The Avid business grew 20% in fiscal year 2015 to
- Avid's new state-of-the-art commercial biomanufacturing suite has been formally commissioned. The new facility will double the company's prior manufacturing capacity, supporting up to an additional
$40 million in revenue each year. - As of
February 1, 2016 , Avid Bioservices had a revenue backlog in excess of$58 million under committed contracts from existing clients, covering services to be completed in the fourth quarter of FY 2016 and into FY 2017.
Financial Results
Total revenues for the third quarter of FY 2016 were
Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services provided to its third-party clients for the third quarter FY 2016 were
Total costs and expenses in the third 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 Quarterly Report on Form 10-Q, which will be filed with the
Conference Call
Peregrine will host a conference call and webcast this morning,
To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the
About
In addition to its drug development programs, Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary
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
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) | ||||||||||||
| THREE MONTHS ENDED | NINE MONTHS ENDED | |||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||
| REVENUES: | ||||||||||||
| Contract manufacturing revenue | $ | 6,672,000 | $ | 5,677,000 | $ | 25,574,000 | $ | 17,436,000 | ||||
| License revenue | 37,000 | - | 329,000 | 37,000 | ||||||||
| Total revenues | 6,709,000 | 5,677,000 | 25,903,000 | 17,473,000 | ||||||||
| COSTS AND EXPENSES: | ||||||||||||
| Cost of contract manufacturing | 3,896,000 | 3,113,000 | 13,245,000 | 10,835,000 | ||||||||
| Research and development | 15,156,000 | 11,261,000 | 43,264,000 | 31,465,000 | ||||||||
| Selling, general and administrative | 4,524,000 | 4,325,000 | 13,839,000 | 13,503,000 | ||||||||
| Total costs and expenses | 23,576,000 | 18,699,000 | 70,348,000 | 55,803,000 | ||||||||
| LOSS FROM OPERATIONS | (16,867,000 | ) | (13,022,000 | ) | (44,445,000 | ) | (38,330,000 | ) | ||||
| OTHER INCOME (EXPENSE): | ||||||||||||
| Interest and other income | 34,000 | 29,000 | 691,000 | 108,000 | ||||||||
| Interest and other expense | (14,000 | ) | (1,000 | ) | (14,000 | ) | (1,000 | ) | ||||
| Total other income (expense), net | 20,000 | 28,000 | 677,000 | 107,000 | ||||||||
| NET LOSS | $ | (16,847,000 | ) | $ | (12,994,000 | ) | $ | (43,768,000 | ) | $ | (38,223,000 | ) |
| COMPREHENSIVE LOSS | $ | (16,847,000 | ) | $ | (12,994,000 | ) | $ | (43,768,000 | ) | $ | (38,223,000 | ) |
| Series E preferred stock accumulated dividends | (1,380,000 | ) | (1,033,000 | ) | (3,448,000 | ) | (2,577,000 | ) | ||||
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | (18,227,000 | ) | $ | (14,027,000 | ) | $ | (47,216,000 | ) | $ | (40,800,000 | ) |
| WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: | ||||||||||||
| Basic and Diluted | 227,389,225 | 182,519,923 | 209,549,670 | 180,562,524 | ||||||||
| BASIC AND DILUTED LOSS PER COMMON SHARE | $ | (0.08 | ) | $ | (0.08 | ) | $ | (0.23 | ) | $ | (0.23 | ) |
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
|
2016 | 2015 | ||||||
| Unaudited | |||||||
| ASSETS | |||||||
| CURRENT ASSETS: | |||||||
| Cash and cash equivalents | $ | 67,470,000 | $ | 68,001,000 | |||
| Trade and other receivables, net | 8,599,000 | 3,813,000 | |||||
| Inventories | 15,189,000 | 7,354,000 | |||||
| Prepaid expenses and other current assets, net | 2,346,000 | 1,355,000 | |||||
| Total current assets | 93,604,000 | 80,523,000 | |||||
| Property and equipment, net | 23,846,000 | 15,124,000 | |||||
| Other assets | 1,602,000 | 1,817,000 | |||||
| TOTAL ASSETS | $ | 119,052,000 | $ | 97,464,000 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
| CURRENT LIABILITIES: | |||||||
| Accounts payable | $ | 7,844,000 | $ | 10,385,000 | |||
| Accrued clinical trial and related fees | 6,975,000 | 3,910,000 | |||||
| Accrued payroll and related costs | 4,497,000 | 4,606,000 | |||||
| Deferred revenue | 15,418,000 | 6,630,000 | |||||
| Customer deposits | 22,433,000 | 11,363,000 | |||||
| Other current liabilities | 1,047,000 | 437,000 | |||||
| Total current liabilities | 58,214,000 | 37,331,000 | |||||
| Deferred rent, less current portion | 905,000 | 1,098,000 | |||||
| Commitments and contingencies | |||||||
| STOCKHOLDERS' EQUITY: | |||||||
| Preferred stock - | 2,000 | 2,000 | |||||
| Common stock - | 232,000 | 193,000 | |||||
| Additional paid-in capital | 557,091,000 | 512,464,000 | |||||
| Accumulated deficit | (497,392,000 | ) | (453,624,000 | ) | |||
| Total stockholders' equity | 59,933,000 | 59,035,000 | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 119,052,000 | $ | 97,464,000 | |||
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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