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Aptevo Therapeutics Reports Second Quarter 2017 Financial Results
Showcases Differentiating Features of the ADAPTIR™
Protein Therapeutic Platform at Prominent Industry Conferences
Signs Collaboration Agreement with Alligator Bioscience Expanding Aptevo’s Portfolio to Include a New Bispecific Antibody Candidate with a Novel Mechanism of Action Targeting 4-1BB, a Compelling Biological Pathway Implicated in Numerous Solid Tumor Indications
“I’m extremely proud of our achievements so far in 2017, particularly when you consider our short history as an independent company,” commented
“As an emerging new class of therapeutics, bispecific antibodies hold promise for the treatment of a variety of serious and chronic diseases. With two new bispecific candidates announced in 2017, APVO436 and ALG.APV-527, and a growing appreciation in the scientific community for the potential therapeutic utility of this new class of engineered proteins, we are excited to continue our progress on this effort and look forward to providing information around our investigational new drug (IND) strategy for these candidates later this year,” said Mr. White.
Second Quarter 2017 Highlights
- Introduced new IXINITY commercial supply to the market in May; completed successful manufacture of new bulk drug substance batches of IXINITY confirming resolution of the bulk drug substance manufacturing challenge.
- Presented new clinical data evaluating the safety and efficacy of IXINITY in children with Hemophilia B, showing that IXINITY appears to be safe and well tolerated in this subject population.
- Presented data on the ADAPTIR protein therapeutic platform at two prominent industry conferences, the
Americas Antibody Congress 2017 and the 2017 Next Generation Protein Therapeutics Summit, highlighting the activity, stability, extended half-life and superior manufacturability of Aptevo’s ADAPTIR bispecific antibody candidates. - Selected a new ADAPTIR bispecific candidate, APVO436, and presented comprehensive preclinical data at the
American Association for Cancer Research 2017 annual meeting demonstrating potent in vitro and in vivo immune activation and an extended half-life of 12.5 days in rodents for APVO436. - Announced a collaboration agreement with
Alligator Bioscience to jointly develop and advance a lead bispecific antibody candidate, ALG.APV-527, with a novel mechanism of action targeting 4-1BB and an undisclosed tumor antigen, demonstrating the flexibility of Aptevo’s ADAPTIR protein therapeutic platform.
Second Quarter 2017 Financial Results
Cash Position: Aptevo had cash, cash equivalents, and short-term investments as of
Product Sales Revenue: Total product sales revenue was
Cost of Product Sales: Cost of product sales decreased by
Research and Development Expenses: Research and development expenses decreased by
| For the Three Months Ended June 30, |
|||||||||||||||
| (in thousands) | 2017 | 2016 | Change | ||||||||||||
| ADAPTIR related programs | $ | 2,276 | $ | 3,277 | $ | (1,001 | ) | ||||||||
| APVO436 | 1,791 | 30 | 1,761 | ||||||||||||
| MOR209/ES414 | 795 | 825 | (30 | ) | |||||||||||
| IXINITY | 619 | 1,140 | (521 | ) | |||||||||||
| otlertuzumab | 413 | 830 | (417 | ) | |||||||||||
| ROR1 | 867 | 1,434 | (567 | ) | |||||||||||
| Other | 27 | 100 | (73 | ) | |||||||||||
| Total | $ | 6,788 | $ | 7,636 | $ | (848 | ) | ||||||||
Selling, General and Administrative Expenses: Selling, general and administrative expenses for the three months ended
Net Loss: Aptevo’s net loss for the three months ended
Financial Statements Follow
| Aptevo Therapeutics Inc. | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (in thousands, except share and per share amounts, unaudited) | ||||||||
| ASSETS | June 30, 2017 | December 31, 2016 |
||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 22,269 | $ | 9,676 | ||||
| Restricted cash | 400 | 400 | ||||||
| Short-term investments | 25,958 | 44,849 | ||||||
| Accounts receivable, net | 4,715 | 4,284 | ||||||
| Inventories | 7,984 | 6,639 | ||||||
| Prepaid expenses and other current assets | 5,867 | 5,566 | ||||||
| Total current assets | 67,193 | 71,414 | ||||||
| Property and equipment, net | 6,205 | 5,910 | ||||||
| Intangible assets, net | 13,493 | 14,534 | ||||||
| Total assets | $ | 86,891 | $ | 91,858 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and other accrued liabilities | $ | 5,349 | $ | 11,489 | ||||
| Accrued compensation | 2,944 | 4,009 | ||||||
| Sales rebates and discounts | 2,146 | 3,235 | ||||||
| Deferred revenue, current portion | 1,444 | 811 | ||||||
| Total current liabilities | 11,883 | 19,544 | ||||||
| Deferred revenue, net of current portion | 2,796 | 2,896 | ||||||
| Long-term debt, net | 18,745 | 18,383 | ||||||
| Other liabilities | 2,047 | 469 | ||||||
| Total liabilities | 35,471 | 41,292 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock: $0.001 par value; 15,000,000 shares authorized, zero shares issued or outstanding | — | — | ||||||
| Common stock: $0.001 par value; 500,000,000 shares authorized; 21,309,744 and 20,271,737 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively | 21 | 20 | ||||||
| Additional paid-in capital | 153,239 | 151,271 | ||||||
| Accumulated other comprehensive loss | (14 | ) | (33 | ) | ||||
| Contribution receivable from former parent | — | (20,000 | ) | |||||
| Accumulated deficit | (101,826 | ) | (80,692 | ) | ||||
| Total stockholders' equity | 51,420 | 50,566 | ||||||
| Total liabilities and stockholders' equity | $ | 86,891 | $ | 91,858 | ||||
| Aptevo Therapeutics Inc. | ||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
| (in thousands, except share and per share amounts, unaudited) | ||||||||
| For the Three Months Ended June 30, |
||||||||
| 2017 | 2016 | |||||||
| Revenues: | ||||||||
| Product sales | $ | 10,750 | $ | 10,159 | ||||
| Collaborations | 14 | 34 | ||||||
| Total revenues | 10,764 | 10,193 | ||||||
| Costs and expenses: | ||||||||
| Cost of product sales | 5,897 | 6,544 | ||||||
| Research and development | 6,788 | 7,636 | ||||||
| Selling, general and administrative | 8,755 | 8,858 | ||||||
| Loss from operations | (10,676 | ) | (12,845 | ) | ||||
| Other income (expense): | ||||||||
| Other income (expense), net | (513 | ) | (4 | ) | ||||
| Total other income (expense), net | (513 | ) | (4 | ) | ||||
| Loss before income taxes | (11,189 | ) | (12,849 | ) | ||||
| Benefit from income taxes | — | (11 | ) | |||||
| Net loss | (11,189 | ) | (12,838 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.53 | ) | $ | (0.63 | ) | ||
| Shares used to compute net loss per share - basic and diluted | 21,265,599 | 20,229,849 | ||||||
About
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including, without limitation, statements regarding Aptevo’s outlook, financial performance or financial condition, our technology and related pipeline, collaboration and partnership opportunities, commercial portfolio, Aptevo’s future growth rates, Aptevo’s ability to timely manufacture its products, and any other statements containing the words “believes,” “expects,” “anticipates,” “intends,” “plans,” “forecasts,” “estimates,” “will” and similar expressions are forward-looking statements. These forward-looking statements are based on Aptevo’s current intentions, beliefs and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo’s expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not undertake to update any forward-looking statement to reflect new information, events or circumstances.
There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements, including possible negative effects on our business operations, assets or financial results as a result of the separation; a deterioration in our business or prospects; the ability of our contractors and suppliers to supply product and materials; our ability and the ability of our contractors and suppliers to maintain compliance with cGMP and other regulatory obligations; the results of regulatory inspections; adverse developments in our customer-base or markets and our ability to retain patients; adverse developments in the U.S. or global capital markets, credit markets or economies generally; and changes in regulatory, social and political conditions. Additional risks and factors that may affect results are set forth in our filings with the
Aptevo Therapeutics Stacey Jurchison Senior Director, Investor Relations and Corporate Communications 206-859-6628 JurchisonS@apvo.com