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Aptevo Therapeutics Reports Third Quarter 2019 Financial Results
Reports Record Net Revenue for IXINITY;
Achieves 55% Increase in Year-over-Year Quarterly Net Revenue
Advances APVO436 Phase 1/1b Clinical Study in AML/MDS
“Net revenue for IXINITY® in the third quarter of 2019 reached a record level at
“Our lead ADAPTIR™ clinical candidate, APVO436, is an optimized bispecific antibody that features improvements over earlier ADAPTIR candidates, including an extended half-life, enhanced potency, desirable manufacturing properties and the potential for reduced immunogenicity. As we reported in our recent conference call, APVO436 is currently being evaluated in a Phase 1/1b clinical study in patients with acute myeloid leukemia and high-grade myelodysplastic syndrome and continues to make solid progress,” continued Mr. White. “This is a particularly important phase of the development program for APVO436 as the preclinical and pharmacokinetic models suggest that in the upcoming dose cohorts we may achieve dose levels of APVO436 with potential clinical effect. We expect to report ongoing progress from the APVO436 Phase 1/1b study over the next several quarters as more clinical data emerge.”
Third Quarter 2019 Highlights
- Reported record quarterly IXINITY net revenue of
$9 million ; achieved a 55% increase in year-over-year IXINITY net revenue in the third quarter of 2019 through continued expansion of the patient base for IXINITY - Continued to expand awareness of IXINITY following the launch of a 3000 IU assay late in the second quarter of 2019, which provides enhanced convenience for patients
- Commenced enrolling clinical sites in preparation to begin dosing in an upcoming clinical study of IXINITY in pediatric patients (under 12 years of age) for potential label expansion of IXINITY in
the United States in a pediatric setting; patients under the age of 12 years currently make up approximately 1/3 of the hemophilia B U.S. treatment population - Continued enrollment in a dose escalation Phase 1/1b open-label clinical study of APVO436 in patients with acute myeloid leukemia and high-grade myelodysplastic syndrome; dosing in Cohort 4 is currently underway; Aptevo anticipates sharing additional data from the study over the next several months
- Presented preclinical data at the 10th Annual World Bispecific Summit on a new ADAPTIR bispecific antibody candidate, APVO603, a dual agonist bispecific antibody employing a novel mechanism of action to simultaneously target 4-1BB (CD137) and OX40 (CD134), both members of the TNF-receptor family; dual targeting of 4-1BB and OX40 provides synergistic co-stimulation of T cells with the potential to amplify the cytotoxic function of activated T cells and NK cells, potentially leading to more robust anti-tumor responses
- Discontinued development of APVO210 in
October 2019 , the Company’s investigational targeted cytokine bispecific antibody candidate; the decision to discontinue development was based on data from a multiple ascending dose study of APVO210 in healthy volunteers suggesting that it would not meet the desired target product profile for future commercialization - Received an accelerated performance-based
$4.3 million milestone payment from Saol Therapeutics, part of a purchase agreement between Aptevo and Saol, originally executed inAugust 2017 and amended inAugust 2019 , under which Saol acquired three hyperimmune products previously marketed by Aptevo: WinRho SDF, HepaGam B, and VARIZIG - Implemented an expense reduction plan in
October 2019 - Along with Aptevo’s co-development partner,
Alligator Bioscience , the companies made a joint decision to delay submission of the clinical trial authorization for ALG-APV.527 previously planned for the fourth quarter of 2019; the companies are focusing efforts on partnering ALG.APV-527 prior to Phase 1 clinical development and have initiated discussions with potential partners
Third Quarter 2019 Financial Results
Cash Position: Aptevo had cash, cash equivalents, and marketable securities as of
IXINITY Revenue: Product sales of IXINITY increased by
Cost of Product Sales: Cost of product sales for the three months ended
Research and Development Expenses: Research and development expenses increased by
Selling, General and Administrative Expenses: Selling, general and administrative expenses decreased by
Net Loss: Aptevo’s net loss for the three months ended
Financial Statements Follow
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts, unaudited)
| September 30, 2019 |
December 31, 2018 |
|||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 17,683 | $ | 30,635 | ||||
| Accounts receivable, net | 7,918 | 5,220 | ||||||
| Inventories | 7,482 | 1,785 | ||||||
| Prepaid expenses | 2,215 | 6,907 | ||||||
| Other current assets | 1,491 | 4,142 | ||||||
| Total current assets | 36,789 | 48,689 | ||||||
| Restricted cash | 7,498 | 7,448 | ||||||
| Property and equipment, net | 4,271 | 5,202 | ||||||
| Intangible assets, net | 4,628 | 5,250 | ||||||
| Operating lease right-of-use asset | 3,981 | — | ||||||
| Other assets | 3,389 | 905 | ||||||
| Total assets | $ | 60,556 | $ | 67,494 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 12,073 | $ | 11,671 | ||||
| Accrued compensation | 3,483 | 3,898 | ||||||
| Sales rebates and discounts payable | 868 | 1,245 | ||||||
| Loan payable, net | 19,707 | — | ||||||
| Other short-term liabilities | 1,121 | 796 | ||||||
| Total current liabilities | 37,252 | 17,610 | ||||||
| Long-term debt, net | — | 19,278 | ||||||
| Operating lease liability, net of current portion | 3,547 | — | ||||||
| Other liabilities | 12 | 200 | ||||||
| Total liabilities | 40,811 | 37,088 | ||||||
| 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; 45,279,244 and 22,808,416 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively |
45 | 23 | ||||||
| Additional paid-in capital | 179,382 | 157,791 | ||||||
| Accumulated deficit | (159,682 | ) | (127,408 | ) | ||||
| Total stockholders' equity | 19,745 | 30,406 | ||||||
| Total liabilities and stockholders' equity | $ | 60,556 | $ | 67,494 | ||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts, unaudited)
| For the Three Months Ended September 30, |
For the Nine Months Ended September 30, |
|||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product sales | $ | 9,011 | $ | 5,824 | $ | 23,393 | $ | 16,721 | ||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of product sales | 3,959 | 2,437 | 13,791 | 6,752 | ||||||||||||
| Research and development | 9,125 | 8,574 | 24,143 | 26,486 | ||||||||||||
| Selling, general and administrative | 6,476 | 6,940 | 20,344 | 21,556 | ||||||||||||
| Loss from operations | (10,549 | ) | (12,127 | ) | (34,885 | ) | (38,073 | ) | ||||||||
| Other expense from continuing operations | (625 | ) | (435 | ) | (1,639 | ) | (1,488 | ) | ||||||||
| Loss before income tax | (11,174 | ) | (12,562 | ) | (36,524 | ) | (39,561 | ) | ||||||||
| Benefit from income tax | 999 | — | 999 | — | ||||||||||||
| Net loss from continuing operations | (10,175 | ) | (12,562 | ) | (35,525 | ) | (39,561 | ) | ||||||||
| Discontinued operations (Note 11): | ||||||||||||||||
| Income from discontinued operations, before income taxes | 4,250 | — | 4,250 | — | ||||||||||||
| Income tax expense | (999 | ) | — | (999 | ) | — | ||||||||||
| Income from discontinued operations | 3,251 | — | 3,251 | — | ||||||||||||
| Net loss | $ | (6,924 | ) | $ | (12,562 | ) | $ | (32,274 | ) | $ | (39,561 | ) | ||||
| Basic and diluted per share amounts: | ||||||||||||||||
| Net loss from continuing operations | $ | (0.23 | ) | $ | (0.55 | ) | $ | (0.90 | ) | $ | (1.76 | ) | ||||
| Income from discontinued operations | $ | 0.07 | $ | — | $ | 0.08 | $ | — | ||||||||
| Net loss per basic share | $ | (0.16 | ) | $ | (0.55 | ) | $ | (0.82 | ) | $ | (1.76 | ) | ||||
| Weighted-average shares used to compute per share calculations |
45,169,864 | 22,672,721 | 39,341,974 | 22,431,146 | ||||||||||||
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 potential milestone payments, Aptevo’s outlook, financial performance or financial condition, Aptevo’s technology and related pipeline, collaboration and partnership opportunities, commercial portfolio, milestones, 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 Aptevo’s actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo’s business or prospects; adverse developments in research and development; 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 Aptevo’s filings with the
Source:
Senior Director, Investor Relations and Corporate Communications
206-859-6628
JurchisonS@apvo.com
Source: Aptevo Therapeutics Inc.