AVEO Oncology Reports Third Quarter 2022 Financial Results
– Total Q3 2022 Net Revenue of
– Announced entering a definitive agreement under which LG Chem will acquire AVEO for
Third Quarter 2022 Financial Highlights
September 30, 2022, AVEO reported $77.4 million in cash, cash equivalents and marketable securities, as compared with $77.2 million at the end of June 30, 2022and $87.3 million at December 31, 2021.
- Total revenue for the third quarter of 2022 was approximately
$30.4 millioncompared with $15.2 million for the third quarter of 2021.
U.S.net product revenue was $30.2 million for the third quarter of 2022 compared with $25.0 million in the second quarter of 2022 and $14.3 millionfor the third quarter of 2021.
- In the third quarter of 2022, 1,284 commercial prescriptions were filled, representing an 11% increase compared with 1,157 filled in the second quarter of 2022 and a 107% increase compared with 619 filled in the third quarter of 2021.
- Research and development expense for the third quarter of 2022 was
$11.1 million compared with $7.5 million for the third quarter of 2021.
- Selling, general and administrative expense for the third quarter of 2022 was
$17.6 million compared with $15.1 million for the third quarter of 2021.
- Net loss for the third quarter of 2022 was
$3.3 million, or net loss of $0.09per basic and diluted share, compared with a net loss of $10.4 millionfor the third quarter of 2021, or net loss of $0.30per basic and diluted share.
The United States Patent and Trademark Office is expected to grant AVEO's patent application directed to methods of treating subjects with refractory advanced renal cell carcinoma using tivozanib on
Proposed LG Chem Transaction
The transaction, which was unanimously approved by both companies’ Boards of Directors, is expected to close in early 2023, subject to customary closing conditions, including approval by AVEO shareholders and receipt of regulatory approvals. The transaction is not subject to any financing condition. LG Chem expects to finance the transaction with existing and available cash resources. Upon completion of the transaction, AVEO’s shares will no longer trade on the Nasdaq.
Due to the pending transaction, AVEO will not host a conference call to discuss its quarterly financial results and withdraws its previously issued financial guidance for fiscal year 2022, last updated on
About FOTIVDA® (tivozanib)
FOTIVDA® (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2 and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received
FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Hypertension and Hypertensive Crisis: Control blood pressure prior to initiating FOTIVDA. Monitor for hypertension and treat as needed. For persistent hypertension despite use of anti-hypertensive medications, reduce the FOTIVDA dose.
Cardiac Failure: Monitor for signs or symptoms of cardiac failure throughout treatment with FOTIVDA.
Cardiac Ischemia and Arterial Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe arterial thromboembolic events, such as myocardial infarction and stroke.
Venous Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe venous thromboembolic events.
Hemorrhagic Events: Closely monitor patients who are at risk for or who have a history of bleeding.
Proteinuria: Monitor throughout treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment with FOTIVDA.
Thyroid Dysfunction: Monitor before initiation and throughout treatment with FOTIVDA.
Risk of Impaired Wound Healing: Withhold FOTIVDA for at least 24 days before elective surgery. Do not administer for at least 2 weeks following major surgery and adequate wound healing. The safety of resumption of FOTIVDA after resolution of wound healing complications has not been established.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue FOTIVDA if signs or symptoms of RPLS occur.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.
Allergic Reactions to Tartrazine: The 0.89 mg capsule of FOTIVDA contains FD&C Yellow No.5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.
The most common (≥20%) adverse reactions were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis, and the most common Grade 3 or 4 laboratory abnormalities (≥5%) were sodium decreased, lipase increased, and phosphate decreased.
Strong CYP3A4 Inducers: Avoid coadministration of FOTIVDA with strong CYP3A4 inducers.
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed.
Females and Males of Reproductive Potential: Can impair fertility.
Hepatic Impairment: Adjust dosage in patients with moderate hepatic impairment. Avoid use in patients with severe hepatic impairment.
To report SUSPECTED ADVERSE REACTIONS, contact
Please see FOTIVDA Full Prescribing Information which is available at www.FOTIVDA.com.
About Advanced Renal Cell Carcinoma
According to the American Cancer Society’s 2021 statistics, renal cell carcinoma (RCC) is the most common type of kidney cancer, which is among the ten most common cancers in both men and women. Approximately 73,750 new cases of kidney cancer will be diagnosed annually and about 14,830 people will die from this disease. In patients with late-stage disease, the five-year survival rate is 13%. Agents that target the vascular endothelial growth factor (VEGF) pathway have shown significant antitumor activity in RCC.3 According to a 2019 publication, 50% of the approximately 10,000 patients who progress following two or more lines of therapy choose not to receive further treatment,4 which may be attributable to tolerability concerns and a lack of data to support evidence-based treatment decisions in this highly relapsed or refractory patient population.
AVEO is a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the
This communication may be deemed solicitation material in respect of the proposed acquisition of AVEO by LG Chem. AVEO expects to file with the
Participants in the Solicitation
AVEO and its directors, executive officers and certain other members of management and employees may be deemed to be participants in soliciting proxies from AVEO’s stockholders in connection with the proposed merger. Information regarding the persons who may, under the rules of the
Cautionary Note Regarding Forward-Looking Statements
This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. These forward-looking statements generally include statements that are predictive in nature and depend on or refer to future events or conditions, and include words such as “expect,” “anticipate,” “outlook,” “could,” “target,” “project,” “intend,” “plan,” “believe,” “seek,” “estimate,” “should,” “may,” “assume” and “continue” as well as variations of such words and similar expressions. By their nature, forward-looking statements involve risks and uncertainty because they relate to events and depend on circumstances that will occur in the future, and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Forward-looking statements include, among other things, statements about the potential benefits of the proposed acquisition of AVEO by LG Chem (the “proposed transaction”); the prospective performance and outlook of AVEO’s business, performance and opportunities; any potential strategic benefits, synergies or opportunities expected as a result of the proposed transaction; the ability of the parties to complete the proposed transaction and the expected timing of completion of the proposed transaction; as well as any assumptions underlying any of the foregoing.
These statements are not guarantees of future performance and they involve certain risks, uncertainties and assumptions that are difficult to predict. We caution you that actual outcomes and results may differ materially from what is expressed, implied or forecasted by our forward-looking statements. There can be no guarantee that the proposed transaction will be completed, or that it will be completed as currently proposed, or at any particular time. Neither can there be any guarantee that AVEO will achieve any particular future financial results. In particular, our expectations could be affected by, among other things: the risk that the proposed transaction may not be completed in a timely manner or at all; the possibility that competing offers or acquisition proposals for AVEO will be made; the possibility that required regulatory, stockholder or other approvals or other conditions to the consummation of proposed transaction may not be satisfied on a timely basis or at all (and the risk that such approvals may result in the imposition of conditions that could adversely affect LG Chem or AVEO or the expected benefits of the proposed transaction); regulatory actions or delays or government regulation generally, including potential regulatory actions or delays relating to the completion of the potential transaction; the occurrence of any event, change or other circumstance that could give rise to the right of LG Chem or AVEO to terminate the definitive merger agreement governing the terms and conditions of the proposed transaction; effects of the announcement, pendency or consummation of the proposed transaction on AVEO’s ability to retain and hire key personnel, its ability to maintain relationships with its customers, suppliers and others with whom it does business, its business generally or its stock price; risks related to the diversion of management’s attention from ongoing business operations and opportunities; the risk that stockholder litigation in connection with the proposed transaction may result in significant costs of defense, indemnification and liability; the possibility that the proposed transaction may be more expensive to complete than anticipated, including as a result of unexpected factors or events; and other risks and factors referred to from time to time in AVEO’s filings with the
ZS Associates. US emerging pharma and biotech first launches: A story of over-and underperformance. June 21, 2022.
- Pawlowski N et al. AACR 2013. Poster 3971.
- J Angulo and O Shapiro, Cancers (
Basel) 2019 Sep; 11(9): 1227. [10.3390/cancers11091227] Decision Resources. RCC landscape and forecast. December 12, 2019.
AVEO Investor Relations Contact:
AVEO Public Relations Contact:
Consolidated Statements of Operations
(In thousands, except per share amounts)
|Three Months Ended
||Nine Months Ended
|Partnership licensing and royalty revenue||259||855||1,391||2,530|
|Cost of products sold||3,964||1,744||9,463||2,704|
|Research and development||11,074||7,502||33,552||20,177|
|Selling, general and administrative||17,579||15,142||51,991||45,162|
|Loss from operations||(2,168||)||(9,215||)||(18,333||)||(43,394||)|
|Other income (expense), net:|
|Interest expense, net||(1,098||)||(1,153||)||(3,451||)||(2,892||)|
|Change in fair value of PIPE Warrant liability||—||—||—||199|
|Net loss per share||$||(0.09||)||$||(0.30||)||$||(0.63||)||$||(1.44||)|
|Weighted average number of common shares outstanding||34,618||34,374||34,533||32,081|
Consolidated Balance Sheet Data
|Cash, cash equivalents and marketable securities||$||77,398||$||87,326|
|Trade receivables, net and partnership receivables||19,764||11,601|
|Prepaid expenses and other current assets||2,463||4,153|
|Property and equipment, net||225||276|
|Operating lease right-of-use asset||32||178|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||30,928||$||18,142|
|Loans payable, net of discount||38,678||37,960|
|Deferred revenue and research and development reimbursements||—||578|
|Operating lease liability||2||11|
|Total liabilities and stockholders’ equity||$||101,233||$||105,341|
Source: AVEO Pharmaceuticals, Inc.