-- Fiscal 2019 Projected Revenue of $51 to $55 Million Reaffirmed --
-- Signed Project Expansion Orders for $6.3 Million with Current Customers --
-- Successfully Executed Scheduled Broad Scale Facilities Maintenance and Upgrade Program --
TUSTIN, Calif., Dec. 10, 2018 (GLOBE NEWSWIRE) -- Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, today announced financial results for the second quarter of fiscal year (FY) 2019 ended October 31, 2018, and provided an update on its contract manufacturing operations, and other corporate highlights.
Highlights Since July 31, 2018
“During the second quarter we have made very significant progress in both the commercial arena and in our operations as we continue to execute to plan. Re-launching the company as a dedicated biologics contract development and manufacturing organization is a challenging endeavor and I am exceptionally pleased with our progress,” said Roger Lias, Ph.D., Avid’s president and chief executive officer.
“On the commercial front we continue to see strong demand and we are making substantial progress in advancing both new and existing projects and improving our profitability. We are engaged in negotiations on new programs that will contribute revenue both during the current fiscal year and through fiscal year 2020 and, perhaps more importantly, many of our current customer programs expanded during the quarter. In addition to securing nearer-term business, our recently installed and highly experienced business development team is advancing longer lead time discussions with established biopharmaceutical clients for future commercial opportunities.
“To support the on-boarding of new projects and to deliver robust, compliant and cost-effective processes to our expanding and diversifying customer base, we continue to strengthen our process development function via the expansion and enhancement of our laboratories and the addition of state-of-the-art equipment. Process development services will become an increasingly important contributor to revenue and will build a strong pipeline of future manufacturing opportunities.
“It’s pleasing to be able to report revenue of over $10 million and a backlog of $36 million during a quarter in which revenue generating potential was limited by planned sequential maintenance shutdowns of both of Avid’s cGMP manufacturing facilities. These shutdowns, during which we undertook important maintenance activities and upgraded systems represent the most comprehensive overhaul program in the company’s history and were crucial to maintaining compliance; serving our current clients and winning new business, as well as minimizing operational and regulatory risk.
“Collectively our significant operational and commercial progress, along with diligent management of our financial resources position Avid Bioservices well for transition to cash generation and positive EBITDA.”
Recent Developments
Financial Highlights and Guidance
More detailed financial information and analysis may be found in Avid’s Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.
Conference Call
Avid will host a conference call and webcast this afternoon, December 10, 2018, at 4:30 PM EST (1:30 PM PST).
To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices conference call. To listen to the live webcast, or access the archived webcast, please visit: http://ir.avidbio.com/events.cfm.
About Avid Bioservices, Inc.
Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture. The company provides a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With 25 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. www.avidbio.com
Forward-Looking Statements
Statements in this press release, which are not purely historical, including statements regarding Avid Bioservices' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk the company may not achieve cash flow or EBITDA positive, the risk the company may experience delays in engaging new clients, the risk that the company may not be successful in executing client projects, the risk that the company may experience technical difficulties in completing client projects which could delay delivery of products to customers, revenue recognition and receipt of payment or the loss of the customer, the risk that one or more existing customers terminates its contract prior to completion or reduces or delays its demand for development or manufacturing services, and the risk that the company may need to use the majority of its cash to fund operations, thereby delaying the in-process upgrades to its process development capabilities and contemplated expansion plans. Our business could be affected by a number of other factors, including the risk factors listed from time to time in our reports filed with the Securities and Exchange Commission including, but not limited to, our annual report on Form 10-K for the fiscal year ended April 30, 2018, as well as any updates to these risk factors filed from time to time in our other filings with the Securities and Exchange Commission. We caution investors not to place undue reliance on the forward-looking statements contained in this press release, and we disclaim any obligation, and do not undertake, to update or revise any forward-looking statements in this press release except as may be required by law.
AVID BIOSERVICES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
(in thousands, except share and per share information)
Three Months Ended October 31, | Six Months Ended October 31, | ||||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||||
Contract manufacturing revenue | $ | 10,178 | $ | 12,782 | $ | 22,767 | $ | 39,859 | |||||||||
Cost of contract manufacturing | 9,844 | 16,242 | 21,241 | 36,690 | |||||||||||||
Gross profit (loss) | 334 | (3,460 | ) | 1,526 | 3,169 | ||||||||||||
Operating expenses: | |||||||||||||||||
Selling, general and administrative | 2,816 | 3,596 | 6,031 | 7,449 | |||||||||||||
Restructuring charges | — | 1,258 | — | 1,258 | |||||||||||||
Total operating expenses | 2,816 | 4,854 | 6,031 | 8,707 | |||||||||||||
Operating loss | (2,482 | ) | (8,314 | ) | (4,505 | ) | (5,538 | ) | |||||||||
Interest and other income, net | 119 | 13 | 181 | 37 | |||||||||||||
Loss from continuing operations before income taxes | $ | (2,363 | ) | $ | (8,301 | ) | $ | (4,324 | ) | $ | (5,501 | ) | |||||
Income tax benefit | 173 | — | 173 | — | |||||||||||||
Loss from continuing operations | $ | (2,190 | ) | $ | (8,301 | ) | $ | (4,151 | ) | $ | (5,501 | ||||||
Income (loss) from discontinued operations, net of tax | 739 | (4,323 | ) | 739 | (8,328 | ) | |||||||||||
Net loss | $ | (1,451 | ) | $ | (12,624 | ) | $ | (3,412 | ) | $ | (13,829 | ) | |||||
Comprehensive loss | $ | (1,451 | ) | $ | (12,624 | ) | $ | (3,412 | ) | $ | (13,829 | ) | |||||
Series E preferred stock accumulated dividends | (1,442 | ) | (1,442 | ) | (2,523 | ) | (2,523 | ) | |||||||||
Net loss attributable to common stockholders | $ | (2,893 | ) | $ | (14,066 | ) | $ | (5,935 | ) | $ | (16,352 | ) | |||||
Basic and diluted weighted average common shares outstanding | 56,008,541 | 45,097,474 | 55,889,325 | 44,935,600 | |||||||||||||
Basic and diluted net (loss) income per common share attributable to common stockholders: | |||||||||||||||||
Continuing operations | $ | (0.06 | ) | $ | (0.21 | ) | $ | (0.12 | ) | $ | (0.18 | ) | |||||
Discontinued operations | $ | 0.01 | $ | (0.10 | ) | $ | 0.01 | $ | (0.18 | ) | |||||||
Net loss per share attributable to common stockholders | $ | (0.05 | ) | $ | (0.31 | ) | $ | (0.11 | ) | $ | (0.36 | ) | |||||
AVID BIOSERVICES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share information)
October 31, 2018 | April 30, 2018 | ||||||
Unaudited | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 32,694 | $ | 42,265 | |||
Trade and other receivables | 4,197 | 3,754 | |||||
Contract assets | 5,092 | — | |||||
Inventories | 9,736 | 16,129 | |||||
Prepaid expenses | 774 | 679 | |||||
Assets of discontinued operations | — | 5,000 | |||||
Total current assets | 52,493 | 67,827 | |||||
Property and equipment, net | 26,279 | 26,479 | |||||
Restricted cash | 1,150 | 1,150 | |||||
Other assets | 302 | 304 | |||||
Total assets | $ | 80,224 | $ | 95,760 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 3,223 | $ | 1,909 | |||
Accrued payroll and related costs | 1,829 | 2,564 | |||||
Contract liabilities | 17,307 | 27,935 | |||||
Other current liabilities | 433 | 905 | |||||
Liabilities of discontinued operations | 416 | 4,550 | |||||
Total current liabilities | 23,208 | 37,863 | |||||
Deferred rent, less current portion | 2,126 | 2,159 | |||||
Capital lease, less current portion | 93 | — | |||||
Commitments and contingencies | |||||||
Stockholders’ equity: | |||||||
Preferred stock—$0.001 par value; 5,000,000 shares authorized; 1,647,760 shares issued and outstanding at October 31, 2018 and April 30, 2018, respectively | 2 | 2 | |||||
Common stock—$0.001 par value; 150,000,000 shares authorized; 56,063,488 and 55,689,222 shares issued and outstanding at October 31, 2018 and April 30, 2018, respectively | 56 | 55 | |||||
Additional paid-in capital | 614,541 | 614,810 | |||||
Accumulated deficit | (559,802 | ) | (559,129 | ) | |||
Total stockholders’ equity | 54,797 | 55,738 | |||||
Total liabilities and stockholders’ equity | $ | 80,224 | $ | 95,760 | |||