Peregrine Pharmaceuticals Reports Financial Results for Second Quarter of Fiscal Year 2017 and Recent Developments
-- Avid Posts Record Revenue of
-- Beta-2 Glycoprotein-1 (β2GP1) Identified as a Biomarker that Correlates with Statistically Significant Improvement in Overall Survival for Patients Receiving the Bavituximab Combination Compared to Chemotherapy Alone from the Phase III SUNRISE Trial --
--
Highlights Since
"The Avid business is on track to continue its revenue growth this fiscal year as we move toward overall profitability within the next 18 months. Our two facilities have the potential to generate in excess of
Avid Bioservices Highlights
"Growing top-line revenue is a key focus and we are pleased to report a 53% improvement in contract manufacturing revenue for the current six-month period compared to the same period last fiscal year. In addition, our revenue guidance for the second quarter was targeted to exceed
- The company reaffirms its manufacturing
revenue guidance for the full FY 2017 of
$50 -$55 million .
- Avid's current manufacturing revenue backlog is
$73 million , representing estimated future manufacturing revenue to be recognized under committed contracts. This backlog mostly covers revenue to be recognized during the remainder of fiscal year 2017 and fiscal year 2018.
Clinical Development Highlights
- Through the ongoing analysis of the Phase III SUNRISE data, Peregrine scientists identified a correlation between overall survival and pre-treatment levels of the biomarker, beta-2 glycoprotein-1 (β2GP1), which we presented at ESMO in October.
- Data demonstrated that patients with pre-treatment β2GP1 levels between 200 and 240 µg/mL - representing
approximately 30% of randomized patients - achieved a statistically significant, 5.5-month improvement, from 7.7 months to 13.2 months, in median overall survival as compared to patients in the control group with the same range of β2GP1 levels.
- Data demonstrated that patients with pre-treatment β2GP1 levels between 200 and 240 µg/mL - representing
approximately 30% of randomized patients - achieved a statistically significant, 5.5-month improvement, from 7.7 months to 13.2 months, in median overall survival as compared to patients in the control group with the same range of β2GP1 levels.
- Peregrine's research collaboration with NCCN is advancing as planned, with grants awarded to three investigators to support research of bavituximab in combination with other therapeutics for the following studies:
- Phase I Trial of Sorafenib and Bavituximab Plus Stereotactic Body Radiation Therapy (SBRT) for Unresectable Hepatitis C Associated Hepatocellular Carcinoma
- Phase I/II Clinical Trial of Bavituximab with Radiation and Temozolomide for Patients with Newly Diagnosed Glioblastoma
- Phase II Study of Pembrolizumab and Bavituximab for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
- Phase I Trial of Sorafenib and Bavituximab Plus Stereotactic Body Radiation Therapy (SBRT) for Unresectable Hepatitis C Associated Hepatocellular Carcinoma
The company expects these trials to begin over the coming months.
Research Highlights
- Peregrine scientists and collaborators from
Duke University Medical Center ,Rutgers University College of Medicine , andMemorial Sloan Kettering Cancer Center each presented compelling data demonstrating that shifts in the tumor microenvironment from immune suppressed to immune active occurred when a bavituximab equivalent antibody was administered as part of a combination treatment regimen. Presentations addressed multiple phosphatidylserine (PS)-targeting combinations, including those with checkpoint inhibitors such as anti-PD-1, anti-PD-L1 and anti-LAG3, as well as with radiation or chemotherapy. These data suggest that the addition of PS-targeting reverses an immunosuppressive tumor environment, creating an immune active tumor microenvironment that can potentially convert patients that generally do not respond to immuno-oncology (I-O) therapies into responders. Key presentations were made at theSecond International Cancer Immunotherapy Conference in September, theAmerican Association for Cancer Research'sTumor Immunology and Immunotherapy Conference in October, theSociety for Immunotherapy of Cancer (SITC) in November, and the San Antonio Breast Cancer Symposium in December.
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 18 months from now. During the first six months of FY 2017, the company made significant progress toward this goal with contract manufacturing revenues increasing 53% compared to the first six months of FY 2016 and research and development expenses decreasing by 45% compared to the first six months of FY 2016.
- Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services provided to its third-party customers increased to
$23,370,000 for the second quarter of FY 2017 compared to$9,523,000 for the second quarter of FY 2016. In addition, as previously-announced, a backlog at a third-party testing lab, unrelated to product quality, required that the recognition of some revenue be shifted from the first quarter to the second quarter of fiscal year 2017.
- Total costs and expenses for the second quarter of FY 2017 were
$27,447,000 , compared to$23,347,000 for the second quarter of FY 2016. For the second quarter of FY 2017, research and development expenses decreased 51% to$7,022,000 , compared to$14,190,000 for the second quarter of FY 2016. Cost of contract manufacturing increased to$15,441,000 in the second quarter of FY 2017 compared to$4,741,000 for the second 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 second quarter of FY 2017, selling, general and administrative expenses increased to$4,984,000 compared to$4,416,000 for the second quarter of FY 2016 primarily due to the company's growing manufacturing business.
- Peregrine's consolidated net loss attributable to common stockholders was
$5,498,000 or$0.02 per share, for the second quarter of FY 2017, compared to a net loss attributable to common stockholders of$14,578,000 , or$0.07 per share, for the same prior year quarter.
- Peregrine reported
$49,055,000 in cash and cash equivalents as ofOctober 31, 2016 , compared to$61,412,000 at fiscal year endedApril 30, 2016 .
- Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services provided to its third-party customers increased to
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 | SIX MONTHS ENDED | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| REVENUES: | ||||||||||||||||
| Contract manufacturing revenue | $ | 23,370,000 | $ | 9,523,000 | $ | 28,979,000 | $ | 18,902,000 | ||||||||
| License revenue | — | — | — | 292,000 | ||||||||||||
| Total revenues | 23,370,000 | 9,523,000 | 28,979,000 | 19,194,000 | ||||||||||||
| COSTS AND EXPENSES: | ||||||||||||||||
| Cost of contract manufacturing | 15,441,000 | 4,741,000 | 18,503,000 | 9,349,000 | ||||||||||||
| Research and development | 7,022,000 | 14,190,000 | 15,591,000 | 28,108,000 | ||||||||||||
| Selling, general and administrative | 4,984,000 | 4,416,000 | 10,044,000 | 9,315,000 | ||||||||||||
| Total costs and expenses | 27,447,000 | 23,347,000 | 44,138,000 | 46,772,000 | ||||||||||||
| LOSS FROM OPERATIONS | (4,077,000 | ) | (13,824,000 | ) | (15,159,000 | ) | (27,578,000 | ) | ||||||||
| Interest and other income | 21,000 | 626,000 | 46,000 | 657,000 | ||||||||||||
| NET LOSS | $ | (4,056,000 | ) | $ | (13,198,000 | ) | $ | (15,113,000 | ) | $ | (26,921,000 | ) | ||||
| COMPREHENSIVE LOSS | $ | (4,056,000 | ) | $ | (13,198,000 | ) | $ | (15,113,000 | ) | $ | (26,921,000 | ) | ||||
| Series E preferred stock accumulated dividends | (1,442,000 | ) | (1,380,000 | ) | (2,477,000 | ) | (2,413,000 | ) | ||||||||
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | (5,498,000 | ) | $ | (14,578,000 | ) | $ | (17,590,000 | ) | $ | (29,334,000 | ) | ||||
| WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: | ||||||||||||||||
| Basic and Diluted | 244,815,767 | 203,942,411 | 242,205,428 | 200,629,892 | ||||||||||||
| BASIC AND DILUTED LOSS PER COMMON SHARE | $ | (0.02 | ) | $ | (0.07 | ) | $ | (0.07 | ) | $ | (0.15 | ) | ||||
CONDENSED CONSOLIDATED BALANCE SHEETS
2016 | 2016 | |||||||
| Unaudited | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 49,055,000 | $ | 61,412,000 | ||||
| Trade and other receivables | 6,066,000 | 2,859,000 | ||||||
| Inventories | 25,924,000 | 16,186,000 | ||||||
| Prepaid expenses and other current assets | 1,711,000 | 1,351,000 | ||||||
| Total current assets | 82,756,000 | 81,808,000 | ||||||
| Property and equipment, net | 23,957,000 | 24,302,000 | ||||||
| Restricted cash | 600,000 | 600,000 | ||||||
| Other assets | 2,624,000 | 2,333,000 | ||||||
| TOTAL ASSETS | $ | 109,937,000 | $ | 109,043,000 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable | $ | 11,572,000 | $ | 8,429,000 | ||||
| Accrued clinical trial and related fees | 3,639,000 | 7,594,000 | ||||||
| Accrued payroll and related costs | 5,280,000 | 5,821,000 | ||||||
| Deferred revenue | 17,980,000 | 10,030,000 | ||||||
| Customer deposits | 26,928,000 | 24,212,000 | ||||||
| Other current liabilities | 1,012,000 | 1,488,000 | ||||||
| Total current liabilities | 66,411,000 | 57,574,000 | ||||||
| Deferred rent, less current portion | 1,347,000 | 1,395,000 | ||||||
| Commitments and contingencies | ||||||||
| STOCKHOLDERS' EQUITY: | ||||||||
| Preferred stock - | 2,000 | 2,000 | ||||||
| Common stock-$0.001 par value; authorized 500,000,000 shares; 251,765,279 and 236,930,485 issued and outstanding at | 252,000 | 237,000 | ||||||
| Additional paid-in capital | 566,314,000 | 559,111,000 | ||||||
| Accumulated deficit | (524,389,000 | ) | (509,276,000 | ) | ||||
| Total stockholders' equity | 42,179,000 | 50,074,000 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 109,937,000 | $ | 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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