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Achieves Record Annual IXINITY® Net Revenue of $23.1 Million Representing 111% Increase Over 2017
Advances APVO436 Into Phase 1/1b Clinical Trial for Treatment of Acute Myeloid Leukemia and High-Grade Myelodysplastic Syndrome
Receives Authorization to Commence Dosing in Phase 1 Clinical Trial of APVO210; Dosing Scheduled to Begin March 2019
Progresses Novel 4-1BB/5T4 Bispecific Antibody ALG.APV-527 Towards CTA Filing in Q4 2019
SEATTLE, March 18, 2019 (GLOBE NEWSWIRE) -- Aptevo Therapeutics Inc. (Nasdaq: APVO), a biotechnology company focused on developing novel oncology, autoimmune and hematology therapeutics, today reported its financial results for the year ended December 31, 2018 and provided an update on its development programs.
“Aptevo continued to make important progress in 2018 in both our pipeline and commercial programs setting up 2019 as a pivotal year for the Company,” said Marvin L. White, President and Chief Executive Officer. “First, we continue to be pleased with the growth trajectory for IXINITY and our success onboarding new patients. Net revenue for IXINITY in 2018 more than doubled to $23.1 million from $10.9 million in 2017. New patient on-boarding has continued at a gratifying level thus far in 2019, and therefore we are optimistic about further momentum in our IXINITY business generally, and from the launch of new growth initiatives this year. These include: seeking a pediatric label expansion for IXINITY (as more than a third of patients with Hemophilia B in the U.S. are under the age of 12); introducing a more convenient 3,000 IU assay for patients; and finally, pursuing ex-US licensing and partnership opportunities for IXINITY. We believe these initiatives will allow us to continue to grow our footprint for IXINITY in the U.S. and internationally.
We also reached a key milestone in 2018 – advancing our lead, next-generation ADAPTIR™ bispecific antibody candidate, APVO436, into clinical development. We are particularly excited about this achievement as pre-clinical data for APVO436 has shown promising attributes, specifically by inducing lower levels of several key T cell cytokines compared to a competitor candidate, which have been associated with serious adverse events in clinical studies with other T-cell engagers. We look forward to evaluating this attribute in our clinical studies, as it would represent an important advantage for our molecule vis-à-vis other bispecific approaches.
With APVO436 solidly on track, we are poised to also begin a Phase 1 study this month of our second ADAPTIR candidate, APVO210 – a novel bispecific antibody intended for the treatment of autoimmune and inflammatory diseases. The Phase 1 study, which is being conducted in Australia, has received authorization to begin dosing of APVO210 in healthy volunteers and will commence imminently. APVO210 has a unique mechanism of action to deliver IL-10 without causing lymphocyte stimulation, which could represent a critical improvement in IL-10 therapies for autoimmune disease.
With two novel ADAPTIR bispecific candidates now advancing in the clinic towards important data read-outs later this year, IXINITY revenues growing, and the proceeds from our equity offering completed in March 2019, we are well-positioned from a cash perspective and anticipate 2019 will potentially be a transformative year for Aptevo,” concluded Mr. White.
ADAPTIR Pipeline (APVO436 / APVO210 / ALG.APV-527)
2018 Summary Financial Results
Cash Position: Aptevo had cash, cash equivalents, and short-term investments as of December 31, 2018 totaling $38.1 million, including $7.5 million in restricted cash.
Product Revenue: Revenue for IXINITY for the year ended December 31, 2018 increased approximately 111% to $23.1 million from $10.9 million for the year ended December 31, 2017. This increase was primarily related to the continuing expansion of Aptevo’s IXINITY Hemophilia B patient base and expansion of the Company’s distribution channel for IXINITY.
Collaborations revenue for 2017 was due to a one-time recognition of the remaining deferred revenue related to Aptevo’s collaboration with MorphoSys, which was terminated in the third quarter of 2017.
Cost of Product Sales: Cost of product sales increased by $6.2 million, or 124%, to $11.2 million for the year ended December 31, 2018 from $5.0 million for the year ended December 31, 2017.
The increase in cost of product sales is mainly due to the increase in product sales, as well as lower cost of inventory in 2017 due to inventory being received in settlement against an outstanding inventory credit.
Research and Development Expenses: Research and development expenses increased by $6.4 million to $35.4 million for the year ended December 31, 2018 compared to $29.0 million for the year ended December 31, 2017. The increase in research and development expenses is primarily related to manufacturing costs for clinical drug product for APVO436 and APVO210, and increased activities around the development of new ADAPTIR pipeline candidates.
Selling, General and Administrative Expenses: Selling, general and administrative expenses decreased by $6.4 million, or 19%, to $28.1 million for the year ended December 31, 2018, compared to $34.5 million for the year ended December 31, 2017. The decrease was primarily due to reduced personnel and professional services costs.
Net Income (Loss): Aptevo’s net loss for the year ended December 31, 2018 was ($53.7) million or $(2.39) per share, compared to a net income of $7.0 million or $0.33 per share for the corresponding period in 2017. Net income in 2017 is due to income from discontinued operations in connection with the sale of the Company’s Hyperimmune Business in 2017, and allocation of income tax benefit as required by GAAP, offset by the Company’s losses from operations.
Aptevo 2019 Milestones:
Aptevo Therapeutics Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)
|As of December 31,|
|Cash and cash equivalents||$||30,635||$||7,095|
|Other current assets||4,142||6,710|
|Total current assets||48,689||95,084|
|Restricted cash, net of current portion||7,448||10,000|
|Property and equipment, net||5,202||5,843|
|Intangible assets, net||5,250||6,080|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable and other accrued liabilities||$||11,671||$||7,350|
|Sales rebates and discounts payable||1,245||623|
|Current portion of long-term debt||—||3,333|
|Other current liabilities||796||2,578|
|Total current liabilities||17,610||18,510|
|Long-term debt, net||19,278||15,728|
|Preferred stock: $0.001 par value; 15,000,000 shares authorized, zero shares
issued or outstanding
|Common stock: $0.001 par value; 500,000,000 shares authorized; 22,808,416
and 21,605,716 shares issued and outstanding at December 31, 2018 and
December 31, 2017, respectively
|Additional paid-in capital||157,791||155,837|
|Accumulated other comprehensive loss||—||(105||)|
|Total stockholders' equity||30,406||82,035|
|Total liabilities and stockholders' equity||$||67,494||$||117,007|
Aptevo Therapeutics Inc.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
|For the Year Ended December 31,|
|Costs and expenses:|
|Cost of product sales||11,214||5,010|
|Research and development||35,385||29,021|
|Selling, general and administrative||28,133||34,576|
|Loss from operations||(51,665||)||(53,949||)|
|Other expense, net||(2,024||)||(1,944||)|
|Loss before income taxes||(53,689||)||(55,893||)|
|Benefit from income taxes||—||23,301|
|Net loss from continuing operations||(53,689||)||(32,592||)|
|Discontinued operations (Note 2):|
|Income from discontinued operations, before income taxes||—||62,864|
|Income tax expense||—||(23,299||)|
|Income from discontinued operations||—||39,565|
|Net income (loss)||$||(53,689||)||$||6,973|
|Basic and diluted net income (loss) per share:|
|Net loss from continuing operations||$||(2.39||)||$||(1.53||)|
|Net income from discontinued operations||$||—||$||1.86|
|Net income (loss)||$||(2.39||)||$||0.33|
|Weighted-average shares used to compute per share calculation||22,500,053||21,335,157|
About Aptevo Therapeutics Inc.
Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on novel oncology and hematology therapeutics to meaningfully improve patients’ lives. Aptevo has a commercial product, IXINITY® coagulation factor IX (recombinant), approved and marketed in the United States for the treatment of Hemophilia B, and a versatile core technology – the ADAPTIR™ modular protein technology platform capable of generating highly-differentiated bispecific antibodies with unique mechanisms of action to treat cancer and autoimmune diseases. Aptevo has a broad pipeline of novel investigational-stage bispecific antibody candidates focused in immuno-oncology and autoimmune disease and inflammation. For more information, please visit www.aptevotherapeutics.com
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 Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, as filed on March 18, 2019 and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo’s expectations in any forward-looking statement.
Senior Director, Investor Relations and Corporate Communications