Peregrine Pharmaceuticals Reports Financial Results for the Third Quarter of Fiscal Year 2017 and Recent Developments
-- Avid Revenue Guidance Increased to
-- Multiple Preclinical Studies Demonstrating Bavituximab's Ability to Enhance Activity of Immune Stimulating Therapies Accepted for Presentation at AACR --
Highlights Since
"During the third quarter, Avid's revenue growth continued, which is a strong indicator of the increasing value of this contract development and manufacturing organization (CDMO) business. The steady growth of this business over the past 5 years has been remarkable and we are pleased to see the trend continuing as we move through a number of process validations for clients, which we expect to spur further growth in the future as some or all of those products move to commercialization. We see Avid as a tremendously important asset with solid upside potential that is often overlooked as a value driver for the overall organization. With projected revenue of over
"As we look to the future, based on current operations and projected demand from our existing clients, we have also recently secured additional space within the same building as our Myford facility for which we already have use as part of our existing operations but would also allow us to further expand capacity based on committed business. While we will only begin converting the space into manufacturing capacity once client commitments and other necessary financing is in place, this puts us in an excellent position for continuing to grow the business beyond the coming fiscal year."
Avid Bioservices Highlights
"The Avid business continues to build momentum. During the third quarter of FY 2017, contract manufacturing revenue increased 61% to
- The company is increasing its manufacturing revenue guidance for the full FY 2017 from
$50 -$55 million , to$60 -$65 million .
- Avid's current manufacturing revenue backlog is
$70 million , representing estimated future manufacturing revenue to be recognized under committed contracts. This backlog primarily covers revenue to be recognized during the remainder of fiscal year 2017 and fiscal year 2018.
Clinical Development Highlights
-- The three clinical trials under the collaboration with the NCCN are advancing as planned.
- Moffitt Cancer Center—A Phase I Trial of Sorafenib and Bavituximab Plus Stereotactic Body Radiation Therapy for Unresectable Hepatitis C Associated Hepatocellular Carcinoma. This protocol is approved and patient screening is expected soon.
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 on track to be initiated by mid-calendar 2017.
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins—Phase II Study of Pembrolizumab and Bavituximab for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck. This trial is on track to be initiated by mid-calendar 2017.
-- The company is continuing its comprehensive biomarker analysis of data collected in the Phase III SUNRISE trial.
- Through this analysis, and as reported previously, Peregrine scientists have identified a correlation between overall survival and pre-treatment levels of the biomarker, beta-2 glycoprotein-1 (β2GP1).
- The results of an analysis of pre-treatment interferon gamma (IFN-ɣ) will be the subject of a presentation at AACR entitled:
IFN-ɣ Analysis in Blood and Tissue as a Potential Prognostic and/or Predictive Biomarker
Research Highlights
-- Peregrine scientists and collaborators from
- Memorial Sloan Kettering: Targeting Phosphatidylserine in Combination with Adoptive T Cell Transfer Eliminates Advanced Tumors without Off-Target Toxicities in a Melanoma Preclinical Model
- Memorial Sloan Kettering (initial findings presented at SITC): Phosphatidylserine Targeting Antibody in Combination with Tumor Radiation and Immune Checkpoint Blockade Promotes Anti-Tumor Activity in Mouse B16
Melanoma
- Peregrine (initial findings presented at the 2016
Society for Immunotherapy of Cancer Meeting ): Combinational Activity of LAG3 and PD-1 Targeted Therapies is Significantly Enhanced by the Addition of Phosphatidylserine Targeting Antibodies and Establishes an Anti-Tumor Memory Response in Murine Triple Negative Breast Cancer
-- Collaborators from the
Financial Highlights and Results
-- Peregrine continues to execute its previously-announced strategy to reach sustained profitability by increasing contract manufacturing revenue while decreasing research and development expenses, with the goal of reaching profitability 15 months from now. During the first nine months of FY 2017, the company made significant progress toward this goal with contract manufacturing revenues increasing 55% compared to the first nine months of FY 2016 and research and development expenses decreasing by 50% compared to the first nine months of FY 2016.
- Contract manufacturing revenue from Avid's biomanufacturing services
provided to its third-party customers increased to
$10,747,000 for the third quarter of FY 2017 compared to$6,672,000 for the third quarter of FY 2016.
- Total costs and expenses for the third quarter of FY 2017 were
$18,544,000 , compared to$23,576,000 for the third quarter of FY 2016. For the third quarter of FY 2017, research and development expenses decreased 60% to$5,989,000 , compared to$15,156,000 for the third quarter of FY 2016. Cost of contract manufacturing increased to$7,974,000 in the third quarter of FY 2017 compared to$3,896,000 for the third quarter of FY 2016, 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 cost of operating the new Myford facility as well as the higher cost associated with performing process validation runs during the quarter. For the third quarter of FY 2017, selling, general and administrative expenses increased slightly to$4,581,000 compared to$4,524,000 for the third quarter of FY 2016 primarily due to the company's growing manufacturing business.
- Peregrine's consolidated net loss attributable to common stockholders was
$9,216,000 or$0.04 per share, for the third quarter of FY 2017, compared to a net loss attributable to common stockholders of$18,227,000 , or$0.08 per share, for the same prior year quarter.
- Peregrine reported
$41,528,000 in cash and cash equivalents as ofJanuary 31, 2017 , compared to$61,412,000 at fiscal year endedApril 30, 2016 .
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 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
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) | |||||||||||||||
| THREE MONTHS ENDED | NINE MONTHS ENDED | ||||||||||||||
| 2017 | 2016 | 2017 | 2016 | ||||||||||||
| REVENUES: | |||||||||||||||
| Contract manufacturing revenue | $ | 10,747,000 | $ | 6,672,000 | $ | 39,726,000 | $ | 25,574,000 | |||||||
| License revenue | — | 37,000 | — | 329,000 | |||||||||||
| Total revenues | 10,747,000 | 6,709,000 | 39,726,000 | 25,903,000 | |||||||||||
| COSTS AND EXPENSES: | |||||||||||||||
| Cost of contract manufacturing | 7,974,000 | 3,896,000 | 26,477,000 | 13,245,000 | |||||||||||
| Research and development | 5,989,000 | 15,156,000 | 21,580,000 | 43,264,000 | |||||||||||
| Selling, general and administrative | 4,581,000 | 4,524,000 | 14,625,000 | 13,839,000 | |||||||||||
| Total costs and expenses | 18,544,000 | 23,576,000 | 62,682,000 | 70,348,000 | |||||||||||
| LOSS FROM OPERATIONS | (7,797,000 | ) | (16,867,000 | ) | (22,956,000 | ) | (44,445,000 | ) | |||||||
| OTHER INCOME (EXPENSE): | |||||||||||||||
| Interest and other income | 25,000 | 34,000 | 71,000 | 691,000 | |||||||||||
| Interest and other expense | (2,000 | ) | (14,000 | ) | (2,000 | ) | (14,000 | ) | |||||||
| Total other income, net | 23,000 | 20,000 | 69,000 | 677,000 | |||||||||||
| NET LOSS | $ | (7,774,000 | ) | $ | (16,847,000 | ) | $ | (22,887,000 | ) | $ | (43,768,000 | ) | |||
| COMPREHENSIVE LOSS | $ | (7,774,000 | ) | $ | (16,847,000 | ) | $ | (22,887,000 | ) | $ | (43,768,000 | ) | |||
| Series E preferred stock accumulated dividends | (1,442,000 | ) | (1,380,000 | ) | (3,558,000 | ) | (3,448,000 | ) | |||||||
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | (9,216,000 | ) | $ | (18,227,000 | ) | $ | (26,445,000 | ) | $ | (47,216,000 | ) | |||
| WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: | |||||||||||||||
| Basic and Diluted | 260,811,553 | 227,389,225 | 248,407,470 | 209,549,670 | |||||||||||
| BASIC AND DILUTED LOSS PER COMMON SHARE | $ | (0.04 | ) | $ | (0.08 | ) | $ | (0.11 | ) | $ | (0.23 | ) | |||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
2017 | 2016 | ||||||
| Unaudited | |||||||
| ASSETS | |||||||
| CURRENT ASSETS: | |||||||
| Cash and cash equivalents | $ | 41,528,000 | $ | 61,412,000 | |||
| Trade and other receivables | 5,883,000 | 2,859,000 | |||||
| Inventories | 33,829,000 | 16,186,000 | |||||
| Prepaid expenses and other current assets | 1,747,000 | 1,351,000 | |||||
| Total current assets | 82,987,000 | 81,808,000 | |||||
| Property and equipment, net | 24,143,000 | 24,302,000 | |||||
| Restricted cash | 600,000 | 600,000 | |||||
| Other assets | 3,587,000 | 2,333,000 | |||||
| TOTAL ASSETS | $ | 111,317,000 | $ | 109,043,000 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
| CURRENT LIABILITIES: | |||||||
| Accounts payable | $ | 7,696,000 | $ | 8,429,000 | |||
| Accrued clinical trial and related fees | 3,127,000 | 7,594,000 | |||||
| Accrued payroll and related costs | 5,637,000 | 5,821,000 | |||||
| Deferred revenue | 26,367,000 | 10,030,000 | |||||
| Customer deposits | 26,210,000 | 24,212,000 | |||||
| Other current liabilities | 941,000 | 1,488,000 | |||||
| Total current liabilities | 69,978,000 | 57,574,000 | |||||
| Deferred rent, less current portion | 1,325,000 | 1,395,000 | |||||
| Commitments and contingencies | |||||||
| STOCKHOLDERS' EQUITY: | |||||||
| Preferred stock—$0.001 par value; authorized 5,000,000 shares; 1,647,760 and 1,577,440 issued and outstanding at | 2,000 | 2,000 | |||||
| Common stock—$0.001 par value; authorized 500,000,000 shares; 271,068,464 and 236,930,485 issued and outstanding at | 271,000 | 237,000 | |||||
| Additional paid-in capital | 571,904,000 | 559,111,000 | |||||
| Accumulated deficit | (532,163,000 | ) | (509,276,000 | ) | |||
| Total stockholders' equity | 40,014,000 | 50,074,000 | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 111,317,000 | $ | 109,043,000 | |||
Contacts:Stephanie 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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