Peregrine Pharmaceuticals Reports Financial Results for First Quarter of Fiscal Year 2018 and Recent Developments
-- Avid Bioservices Records Revenues of
-- Supported by Recent Positive Data, Company is Pursuing Strategic Options for its Research and Development Assets --
"We have been working diligently toward the transformation from an R&D focused business to a business dedicated to a contract development and manufacturing organization or CDMO. The appointment of
Avid Bioservices was established as Peregrine's internal biologics manufacturing and development group, and began formal operations in
Avid Bioservices Highlights
"Avid had a strong first quarter,
recognizing 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
$33 million, representing estimated future manufacturing revenue to be recognized under committed contracts. Most of the backlog is expected to be recognized during the remainder of FY 2018.
Research and Development Highlights
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.
Clinical investigators and Peregrine researchers presented the final clinical results from the company's Phase III SUNRISE trial of bavituximab in patients with previously treated locally advanced or metastatic non-squamous non-small cell lung cancer.
As previously reported, study results demonstrated that the addition of bavituximab to docetaxel did not result in improvement of the study's primary endpoint of overall survival in the intent-to-treat population. However, a subgroup analysis on the final dataset demonstrated that for bavituximab plus docetaxel patients who received subsequent immunotherapy, the median overall survival was not yet reached. This compared to a median overall survival of 12.6 months for patients who received placebo plus docetaxel, and subsequent immunotherapy [HR = 0.46; p = 0.006].
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. Patient dosing was initiated in
- 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.
PS Exosome Technology Highlights:
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 evaluating options to license, partner, or sell this technology.
Financial Highlights and Results
- Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services was
$27,077,000for the first quarter of FY 2018 compared to $5,609,000 for the first quarter of FY 2017. This represents total revenue growth of 383% for FY 2018 compared to the same prior year period. It is important to note that the $27 millionincluded the shipment of $10 millionin product, which was held over from the fourth quarter of 2017 due to delays in shipping at the customer's request. The first quarter increase was primarily attributed to an increase in demand for contract manufacturing services associated with process validation activities in addition to the greater number of manufacturing runs shipped during the quarter.
- Total costs and expenses for the first quarter of FY 2018 were
$28,306,000, compared to $16,691,000for the first quarter of FY 2017. Research and development expenses decreased 57% to $3,645,000, compared to $8,569,000for the first quarter of FY 2017.
- Cost of contract manufacturing increased to
$20,448,000in the first quarter of FY 2018 compared to $3,062,000for the first quarter of FY 2017. This increase is 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 was idle capacity due to lower demand and unavailable capacity during the installation of the new 2,000 liter bioreactors combined with a higher percentage of revenue related to pass through charges, such as raw materials, that are recorded as revenue at cost plus a nominal mark-up, thereby lowering the overall gross margin. During the current quarter, 38% of our revenue was related to pass-through charges versus 20% in the same prior year quarter.
- For the first quarter of FY 2018, selling, general and administrative expenses decreased to
$4,213,000compared to $5,060,000for FY 2017.
- Peregrine's consolidated net loss attributable to common stockholders was
$2,647,000or $0.06per share, for the first quarter of FY 2018, compared to a net loss attributable to common stockholders of $12,437,000, or $0.36per share, for the same prior year quarter.
- Peregrine reported
$37,256,000in cash and cash equivalents as of July 31, 2017, compared to $46,799,000at fiscal year ended April 30, 2017.
More detailed financial information and analysis may be found in Peregrine's Quarterly Report on Form 10-Q, which will be filed with the
Peregrine will host a conference call and webcast this afternoon,
To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the
About Avid Bioservices
Avid Bioservices provides a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 15 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid's services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. For more information about Avid, please visit www.avidbio.com.
Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
|THREE MONTHS ENDED|
|Contract manufacturing revenue||$||27,077,000||$||5,609,000|
|COSTS AND EXPENSES:|
|Cost of contract manufacturing||20,448,000||3,062,000|
|Research and development||3,645,000||8,569,000|
|Selling, general and administrative||4,213,000||5,060,000|
|Total costs and expenses||28,306,000||16,691,000|
|LOSS FROM OPERATIONS||(1,229,000||)||(11,082,000||)|
|OTHER INCOME (EXPENSE):|
|Interest and other income||27,000||25,000|
|Interest and other expense||(3,000||)||—|
|Series E preferred stock accumulated dividends||(1,442,000||)||(1,380,000||)|
|NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS|
|WEIGHTED AVERAGE COMMON SHARES OUTSTANDING|
|Basic and diluted (1)||44,773,727||34,227,870|
|BASIC AND DILUTED LOSS PER COMMON SHARE (1)||$||(0.06||)||$||(0.36||)|
(1) All share and per share amounts of our common stock for all periods presented have been retroactively adjusted to reflect the one-for-seven reverse stock split of our issued and outstanding common stock, which took effect with the opening of trading on
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||37,256,000||$||46,799,000|
|Trade and other receivables||7,884,000||7,742,000|
|Total current assets||70,763,000||89,100,000|
|Property and equipment, net||24,399,000||23,674,000|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued clinical trial and related fees||4,812,000||4,558,000|
|Accrued payroll and related costs||4,844,000||6,084,000|
|Other current liabilities||963,000||993,000|
|Total current liabilities||42,387,000||62,931,000|
|Deferred rent, less current portion||1,880,000||1,599,000|
|Commitments and contingencies|
|STOCKHOLDERS' EQUITY (1):|
|Preferred stock—$0.001 par value; authorized
5,000,000 shares; 1,647,760 issued and outstanding at ||2,000||2,000|
|Common stock—$0.001 par value; authorized 500,000,000
shares; 45,094,154 and 44,014,040 issued and outstanding at ||45,000||44,000|
|Additional paid-in capital||594,482,000||590,971,000|
|Total stockholders' equity||56,008,000||53,582,000|
|TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY||$||100,275,000||$||118,112,000|
(1) All share and per share amounts of our common stock for all periods presented have been retroactively adjusted to reflect the one-for-seven reverse stock split of
our issued and outstanding common stock, which took effect with the opening of trading on
Stephanie Diaz(Investors) Vida Strategic Partners415-675-7401 firstname.lastname@example.org Tim Brons(Media) Vida Strategic Partners415-675-7402 email@example.com
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