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Aptevo Therapeutics Reports First Quarter 2017 Financial Results
Expands ADAPTIR Portfolio and Announces New Bispecific Candidate; Presents Data at the
2016 PEPTALK Conference Showcasing Advantages of the ADAPTIR™ Platform
“Aptevo made important strides in early 2017 in both our development and commercial portfolios,” said
“Also during the first quarter, we were pleased to announce that Aptevo had resumed commercial production of IXINITY,” continued Mr. White. “As a result, we did not experience a supply interruption of IXINITY as originally anticipated. Our proactive and transparent communications with the Hemophilia B community, and the tremendous support of people taking IXINITY enabled us to retain over 90% of patients. I continue to be grateful to our IXINITY family for their patience and encouragement during the last few months. With new IXINITY supply anticipated to be available soon, we have aggressively resumed our new patient acquisition efforts and look forward to returning IXINITY to its growth trajectory.”
First Quarter 2017 Highlights
- Resumed IXINITY commercial production and successfully completed a bulk drug substance batch of IXINITY
- Reinitiated new patient acquisition efforts for IXINITY
- Expanded Aptevo’s ADAPTIR portfolio and announced the selection of an additional RTCC ADAPTIR bispecific antibody candidate, APVO436 – an optimized, next-generation ADAPTIR bispecific molecule targeting the cell-surface receptor CD123, which is highly expressed in multiple hematological malignancies
- Presented data at the 16th Annual PEPTALK conference showcasing the advantages of Aptevo’s ADAPTIR platform, which included, the ability to induce target-dependent RTCC; an extended half-life, and antibody-like manufacturing yields, as well as a favorable cytokine release profile. If these data are confirmed in clinical studies, it could suggest the potential for an improved dosing regimen, and increased therapeutic efficacy compared to other bispecific strategies
- Continued enrollment in the Phase 1, continuous infusion, dose escalation study of MOR209/ES414 – a novel bispecific antibody being developed for the treatment of metastatic castration-resistant prostate cancer; the ongoing Phase 1 study is designed to evaluate the safety and tolerability of escalating doses of MOR209/ES414
- Received a
$20 million non-dilutive cash payment fromEmergent BioSolutions pursuant to a promissory note granted as part of the spin-off of Aptevo
First Quarter 2017 Financial Results
Cash Position: Aptevo had cash, cash equivalents, and marketable securities 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 March 31, | ||||||||||
| (in thousands) | 2017 | 2016 | Change | |||||||
| ADAPTIR related program (1) | $ | 5,711 | $ | 5,267 | $ | 444 | ||||
| IXINITY | 197 | 2,225 | (2,028 | ) | ||||||
| Other | 5 | 609 | (604 | ) | ||||||
| Total | $ | 5,913 | $ | 8,101 | $ | (2,188 | ) | |||
| (1) ADAPTIR related programs also includes other non-disclosed candidates | ||||||||||
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
Credit Agreement Amendment:
Financial Statements Follow
| Aptevo Therapeutics Inc. | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (in thousands, except share and per share amounts, unaudited) | ||||||||
| March 31, 2017 | December 31, 2016 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 14,014 | $ | 9,676 | ||||
| Restricted cash | 400 | 400 | ||||||
| Short-term investments | 46,877 | 44,849 | ||||||
| Accounts receivable, net | 1,926 | 4,284 | ||||||
| Inventories | 8,063 | 6,639 | ||||||
| Prepaid expenses and other current assets | 6,116 | 5,566 | ||||||
| Total current assets | 77,396 | 71,414 | ||||||
| Property and equipment, net | 6,384 | 5,910 | ||||||
| Intangible assets, net | 14,013 | 14,534 | ||||||
| Total assets | $ | 97,793 | $ | 91,858 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and other accrued liabilities | $ | 8,766 | $ | 11,489 | ||||
| Accrued compensation | 2,505 | 4,009 | ||||||
| Sales rebates and discounts | 2,310 | 3,235 | ||||||
| Deferred revenue, current portion | 878 | 811 | ||||||
| Total current liabilities | 14,459 | 19,544 | ||||||
| Deferred revenue, net of current portion | 2,802 | 2,896 | ||||||
| Long-term debt, net | 18,435 | 18,383 | ||||||
| Other liabilities | 611 | 469 | ||||||
| Total liabilities | 36,307 | 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; 21,219,950 and 20,271,737 shares issued and outstanding at March 31, 2017 and December 31, 2016, respectively | 21 | 20 | ||||||
| Additional paid-in capital | 152,143 | 151,271 | ||||||
| Accumulated other comprehensive loss | (41 | ) | (33 | ) | ||||
| Contribution receivable from former parent | — | (20,000 | ) | |||||
| Accumulated deficit | (90,637 | ) | (80,692 | ) | ||||
| Total stockholders' equity | 61,486 | 50,566 | ||||||
| Total liabilities and stockholders' equity | $ | 97,793 | $ | 91,858 | ||||
| Aptevo Therapeutics Inc. | ||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
| (in thousands, except share and per share amounts, unaudited) | ||||||||
| For the Three Months Ended March 31, | ||||||||
| 2017 | 2016 | |||||||
| Revenues: | ||||||||
| Product sales | $ | 7,381 | $ | 7,948 | ||||
| Collaborations | 28 | 119 | ||||||
| Total revenues | 7,409 | 8,067 | ||||||
| Costs and expenses: | ||||||||
| Cost of product sales | 488 | 3,528 | ||||||
| Research and development | 5,913 | 8,101 | ||||||
| Selling, general and administrative | 10,547 | 9,419 | ||||||
| Loss from operations | (9,539 | ) | (12,981 | ) | ||||
| Other income (expense): | ||||||||
| Other income (expense), net | (406 | ) | 80 | |||||
| Total other income (expense), net | (406 | ) | 80 | |||||
| Loss before income taxes | (9,945 | ) | (12,901 | ) | ||||
| Benefit from income taxes | — | 12 | ||||||
| Net loss | (9,945 | ) | (12,889 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.48 | ) | $ | (0.64 | ) | ||
| Shares used to compute net loss per share - basic and diluted | 20,757,111 | 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