AVEO Oncology Reports First Quarter 2022 Financial Results
– Total Q1 2022 Net Revenue of
FOTIVDA® (tivozanib)
– Q1 2022 FOTIVDA Prescriptions Increased by 25% Compared With Q4 2021 –
– Company Reaffirms Full Year 2022 FOTIVDA
– Company to Host Conference Call Today at
“We recently celebrated the one-year anniversary of our
“Our team also continues to advance our pipeline of monoclonal antibodies. Collectively, we believe our commercial and clinical development activities offer exciting opportunities to improve patient care while also building long-term value for our shareholders,” said
First Quarter 2022 and Recent Highlights
- Continued quarter over quarter growth of FOTIVDA
U.S. net product revenue and prescriptions in Q1 2022.- First quarter 2022 U.S. net product revenue increased 20% to
$20.1 million compared withU.S. net product revenue of$16.8 million in the fourth quarter of 2021, which reflects inventory shipped to distributors during the quarter and a gross-to-net estimate of 18.5% during the first quarter of 2022.- 977 commercial prescriptions filled in the first quarter of 2022, representing a 25% increase from 780 commercial prescriptions filled in the fourth quarter of 2021.
- FOTIVDA, based on third party data, has continued to hold its leadership position in the share of new patients starts in third-line R/R RCC for the first quarter. AVEO views new patient share starts as an important leading indicator of progress toward its objective to become the overall market share leader and the standard of care in the third-line R/R RCC setting.
- First quarter 2022 U.S. net product revenue increased 20% to
- Encouraging long-term follow up data for progression free survival (PFS) and overall survival (OS) from the Phase 3 TIVO-3 Clinical Trial of tivozanib in R/R advanced RCC patients were presented at the 2022 ASCO GU Cancers Symposium.
- These new long-term PFS data from patients with five years of follow up further support the durable response and improved PFS previously observed in patients treated with FOTIVDA, including:
- Landmark long-term PFS rates were consistently higher among patients treated with FOTIVDA as compared with patients treated with sorafenib (12% vs. 2% and 8% vs. 0% at three and four years, respectively), representing a clinically meaningful outcome for patients in the third- and fourth-line treatment setting.
- Long-term OS was also analyzed and a non-significant trend favoring FOTIVDA continued to emerge with accumulation of events (HR 0.89).
- These new long-term PFS data from patients with five years of follow up further support the durable response and improved PFS previously observed in patients treated with FOTIVDA, including:
- Topline data for first-line cohort of the DEDUCTIVE trial were presented at the 2022
American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium.- New efficacy and safety data from the first line (cohort A) of the Phase 1b/2 clinical trial of tivozanib in combination with AstraZeneca’s IMFINZI® (durvalumab) demonstrated a 28% partial response (PR) rate and disease control rate of 72% (PR plus stable disease) with a median PFS of 7.3 months and a 1-year OS of 76%. The data continues to support the efficacy and safety of tivozanib as an attractive vascular endothelial growth factor receptor inhibitor to use in combination with immune checkpoint inhibitors in first line metastatic hepatocellular carcinoma (HCC) patients.
- The DEDUCTIVE trial is currently enrolling cohort B of second line patients after treatment with bevacizumab and atezolizumab. This cohort, which will enroll up to 20 subjects, has the potential to be the first clinical study to demonstrate benefit in the emerging population of HCC patients who have previously received immunotherapy.
- Enrollment ongoing for Phase 3 TiNivo-2 Trial in R/R RCC following prior immunotherapy; Expect to complete enrollment in the first half of 2023.
- AVEO continues to enroll patients in the Phase 3 TiNivo-2 clinical trial evaluating tivozanib in combination with nivolumab (OPDIVO®), Bristol Myers Squibb’s antibody directed against PD-1, as compared with tivozanib monotherapy in patients with R/R RCC who have progressed following one or two lines of therapy, one of which was an immune checkpoint inhibitor. If successful, we believe data from this trial has the potential to support
U.S. Food and Drug Administration (FDA) approval of tivozanib in combination with nivolumab in R/R RCC and expand the market opportunity for FOTIVDA into the larger second line R/R RCC setting. Bristol Myers Squibb is providing nivolumab clinical drug supply pursuant to a clinical trial collaboration and supply agreement. AVEO currently expects enrollment in the TiNivo-2 trial to be completed in the first half of 2023.
- AVEO continues to enroll patients in the Phase 3 TiNivo-2 clinical trial evaluating tivozanib in combination with nivolumab (OPDIVO®), Bristol Myers Squibb’s antibody directed against PD-1, as compared with tivozanib monotherapy in patients with R/R RCC who have progressed following one or two lines of therapy, one of which was an immune checkpoint inhibitor. If successful, we believe data from this trial has the potential to support
- Secured clinical trial collaboration and supply agreement with
NiKang Therapeutics, Inc. (NiKang) to evaluate tivozanib in combination with NKT2152.- On track to initiate a Phase 2 clinical trial to evaluate the safety and efficacy of tivozanib in combination with NKT2152, NiKang's hypoxia inducible factor 2α (HIF2α), to treat clear cell RCC in mid-2022.
- Started scale up activities for the manufacturing of ficlatuzumab clinical supply in the second quarter of 2022.
- AVEO started scale up activities for the manufacturing of ficlatuzumab clinical supply in the second quarter of 2022 to enable the initiation of a potential registrational clinical trial in human papillomavirus (HPV) negative recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) in the first half of 2023. AVEO expects to continue to discuss the registrational pivotal clinical trial designs with the FDA and to continue to seek a strategic partner. In
September 2021 , AVEO announced that the FDA granted Fast Track designation for the investigation of the combination of ficlatuzumab and cetuximab for the treatment of patients with R/R HNSCC.
- AVEO started scale up activities for the manufacturing of ficlatuzumab clinical supply in the second quarter of 2022 to enable the initiation of a potential registrational clinical trial in human papillomavirus (HPV) negative recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) in the first half of 2023. AVEO expects to continue to discuss the registrational pivotal clinical trial designs with the FDA and to continue to seek a strategic partner. In
First Quarter 2022 Financial Highlights
- At
March 31, 2022 , AVEO reported$79 .0 million in cash, cash equivalents and marketable securities, as compared with$87 .3 million atDecember 31, 2021 . - Total revenue for the first quarter of 2022 was approximately
$20.9 million compared with$1 .9 million for the first quarter of 2021. - FOTIVDA
U.S. net product revenue was$20 .1 million for the first quarter of 2022 compared with$1.1 million for the first quarter of 2021. - Research and development expense for the first quarter of 2022 was
$10 .2 million compared with$5 .8 million for the first quarter of 2021. - Selling, general and administrative expense for the first quarter of 2022 was
$17 .3 million compared with$15 .1 million for the first quarter of 2021. The increase in selling, general and administrative expense for the first quarter 2022 is primarily due to a full quarter of costs associated with the commercial launch of FOTIVDA. - Net loss for the first quarter of 2022 was
$10.2 million , or net loss of$0.30 per basic and diluted share, compared with a net loss of$22.1 million for the first quarter of 2021, or net loss of$0.81 per basic and diluted share.
Financial Guidance
AVEO believes that its
AVEO currently expects to achieve full year 2022 FOTIVDA
Conference Call and Webcast
In connection with this announcement, AVEO will host a conference call and audio webcast today,
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
INDICATIONS
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.
ADVERSE REACTIONS
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.
DRUG INTERACTIONS
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.2 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,3 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.
About
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
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of AVEO within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. The words “advance,” “aim,” “anticipate,” “believe,” “continue,” “could,” “design,” “estimate,” “expect,” “goal,” “intend,” “look forward,” “may,” “plan,” “potential,” “project,” “promising,” “seek,” “should,” “strategy,” “will,” “would,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: AVEO’s expectations of achieving quarter over quarter sales growth and an increase in its sales ramp of FOTIVDA in future periods; AVEO’s, plans, strategies and ability to successfully sell and distribute FOTIVDA to patients in
Any reference to AVEO’s website address in this press release is intended to be an inactive textual reference only and not an active hyperlink.
References
- 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:
(617) 430-7578
hans@lifesciadvisors.com
AVEO Public Relations Contact:
(609) 241-7352
jfkouten@jfkhealth.com
Consolidated Statements of Operations
(In thousands, except per share amounts)
Three Months Ended |
|||||||
2022 | 2021 | ||||||
Revenues: | |||||||
FOTIVDA |
$ | 20,086 | $ | 1,066 | |||
Partnership licensing and royalty revenue | 834 | 854 | |||||
20,920 | 1,920 | ||||||
Operating expenses: | |||||||
Cost of products sold | 2,434 | 138 | |||||
Research and development | 10,160 | 5,797 | |||||
Selling, general and administrative | 17,337 | 15,100 | |||||
29,931 | 21,035 | ||||||
Loss from operations | (9,011 | ) | (19,115 | ) | |||
Other income (expense), net: | |||||||
Interest expense, net | (1,188 | ) | (611 | ) | |||
Change in fair value of PIPE Warrant liability | — | (2,396 | ) | ||||
(1,188 | ) | (3,007 | ) | ||||
Net loss | $ | (10,199 | ) | $ | (22,122 | ) | |
Net loss per share | $ | (0.30 | ) | $ | (0.81 | ) | |
Weighted average number of common shares outstanding | 34,475 | 27,429 |
Consolidated Balance Sheet Data
(In thousands)
2022 |
2021 |
||||
Assets | |||||
Cash, cash equivalents and marketable securities | $ | 79,038 | $ | 87,326 | |
Trade receivables, net and partnership receivables | 13,774 | 11,601 | |||
Inventory | 1,694 | 1,656 | |||
Prepaid expenses and other current assets | 3,220 | 4,153 | |||
Property and equipment, net | 259 | 276 | |||
Operating lease right-of-use asset | 130 | 178 | |||
Other assets | 100 | 151 | |||
Total assets | $ | 98,215 | $ | 105,341 | |
Liabilities and stockholders’ equity | |||||
Accounts payable and accrued expenses | $ | 20,296 | $ | 18,142 | |
Loans payable, net of discount | 38,189 | 37,960 | |||
Deferred revenue and research and development reimbursements | — | 578 | |||
Operating lease liability | 8 | 11 | |||
Other liabilities | 2,780 | 2,780 | |||
Stockholder’s equity | 36,942 | 45,870 | |||
Total liabilities and stockholders’ equity | $ | 98,215 | $ | 105,341 |

Source: AVEO Pharmaceuticals, Inc.