Highlights:
- During the 12 months ended
September 30, 2022 , Eagle recorded net income of$21.3 million or$1.63 per diluted share and adjusted EBITDA of$125.6 million and non-GAAP earnings per diluted share of$7.54 , a significant increase from 2021.1 - Eagle exited 2022 with an approximate 6%2 share of the commercial segment of the pemetrexed market for its PEMFEXY® product, equating to approximately
$8 million per quarter in revenue3, and anticipates doubling its share by the end of Q1 2023. The Company bought down future royalties on PEMFEXY profits in exchange for a one-time payment of$15 million .4 - Expects
U.S. bendamustine franchise decline to be manageable, maintaining approximately 75% of the gross profit in 2023. Q4 2022 expiration of development partner royalty on the bendamustine franchise profits (BENDEKA®, BELRAPZO® & TREAKISYM®), representing approximately 10% of such profits.
Preliminary 2023 Guidance
- Adjusted EBITDA of
$74.0-$80.0 million 5 - Adjusted non-GAAP earnings per share of
$4.20-$4.53 6 - Adjusted non-GAAP R&D expense of
$41.0-$45.0 million 7
Improved Margins and Contribution for Key Products
- The Company continues to evolve with a more diversified revenue stream
U.S. bendamustine revenue as a percentage of total revenue projected to decline, while maintaining approximately 75% of gross profit in 2023- Expected increase in PEMFEXY sales from 2022 to 2023
- Eagle exited 2022 with an approximate 6% share of the commercial segment of the pemetrexed market, equating to approximately
$8 million per quarter in revenue - Anticipates doubling share by end of Q1 2023
- Company values this segment at approximately
$550 million annually at expected pricing8,9
- Eagle exited 2022 with an approximate 6% share of the commercial segment of the pemetrexed market, equating to approximately
- Elimination/expiration of royalties paid
- Q4 2022 expiration of development partner royalty on bendamustine franchise profits (BENDEKA, BELRAPZO & TREAKISYM) representing approximately 10% of profits historically
- Bought down future royalties on PEMFEXY profits in exchange for one-time payment of
$15 million 10- Includes elimination of 25% royalty on next
$85 million in profit - Reduction in rates on subsequent profits
- Includes elimination of 25% royalty on next
“Our path to achieving our projected earnings per share range of
Commercial and Pipeline Update
- Product portfolio
- Acute
Care Hospital : RYANODEX®, vasopressin, Barhemsys®, Byfavo® - Oncology: BENDEKA, BELRAPZO, PEMFEXY11, TREAKISYM Japan12
- 75-person commercial team covers all products excluding BENDEKA and TREAKISYM
- Acute
- Company projects growth in earnings while still supporting R&D
- Cash flow from legacy products expected to continue to fund R&D and partnerships for branded pipeline, including:
- Landiolol13: NDA under review by FDA
- CAL0214: Global Phase 2 study underway with 276 expected patients in 120 centers expected in 22 countries
- Enalare’s ENA-00115: Fast-track status for post-operative respiratory depression—Enalare expects to start fentanyl toxicology study in early 2023 and expects Phase 2 enrollment as early as Q3 2023
- BARDA16 (award to Enalare worth up to
$50 million to advance intramuscular formulation) andNIH funding for community drug overdose—expect Phase 1 enrollment mid-2023 - Rare Pediatric Disease and Orphan Drug designations for apnea of prematurity—Enalare completed animal proof of concept; designing next set of animal studies and clinical pathway
- BARDA16 (award to Enalare worth up to
About
Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients’ lives. Eagle’s commercialized products include vasopressin, PEMFEXY®, RYANODEX®, BENDEKA®, BELRAPZO®, TREAKISYM® (
Non-GAAP Financial Performance Measures
In addition to financial information prepared in accordance with
Adjusted EBITDA excludes items such as interest expense, interest income, income tax provision, depreciation expense, amortization expense, stock-based compensation expense, fair value adjustments on equity investment, expense of acquired in-process research and development, convertible promissory note related credit losses, fair value adjustments related to derivative instrument, restructuring charges, expense related to collaboration with TYME, and severance.
Adjusted non-GAAP earnings per share information excludes items such as amortization expense, stock-based compensation expense, depreciation expense, expense of acquired in-process research & development, severance, acquisition related costs, legal settlement, non-cash interest expense, fair value adjustments on equity investment, convertible promissory note related adjustments, fair value adjustments related to derivative instruments, foreign currency exchange loss, restructuring charges, inventory step-up and the tax effect of these adjustments.
Adjusted non-GAAP R&D expense excludes items such as stock-based compensation expense, depreciation expense, restructuring charges, severance and expense of acquire in-process research & development.
The Company believes the use of non-GAAP financial measures helps indicate underlying trends in the Company’s business and are important in comparing current results with prior period results and understanding projected operating performance. Non-GAAP financial measures provide the Company and its investors with an indication of the Company’s baseline performance before items that are considered by the Company not to be reflective of the Company’s ongoing results.
Investors should note that reconciliations of the forward-looking or projected non-GAAP financial measures included in this presentation to their most comparable GAAP financial measures cannot be provided because the Company cannot do so without unreasonable efforts due to the unavailability of information needed to calculate the reconciling items and the variability, complexity, and limited visibility of comparable GAAP measures, and the reconciling items that would be excluded from the non-GAAP financial measures in the future. Likewise, the Company is unable to provide projected GAAP financial measures. GAAP projections and reconciliations of the components of projected adjusted non-GAAP R&D expense, adjusted EBITDA and adjusted non-GAAP earnings per share to their most comparable GAAP financial measures are not provided because the quantification of projected GAAP R&D expense, GAAP net income and GAAP earnings per share and the reconciling items between projected GAAP to projected adjusted non-GAAP R&D expense, adjusted EBITDA and adjusted non-GAAP earnings per share cannot be reasonably calculated or predicted at this time without unreasonable efforts. For example, with respect to each of GAAP R&D expense, GAAP net income and GAAP earnings per share, the Company is not able to calculate the favorable or unfavorable expenses related to the fair value adjustments on equity investments and derivative instruments primarily due to nature of these transactions. Such unavailable information could be significant such that actual GAAP R&D expense, GAAP net income and GAAP earnings per share would vary significantly from projected adjusted non-GAAP R&D expense, adjusted EBITDA and adjusted non-GAAP earnings per share.
These non-GAAP financial measures should be considered in addition to, but not as a substitute for, the information prepared in accordance with
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other securities law. Forward-looking statements are statements that are not historical facts. Words and phrases such as “anticipate,” “forward,” “will,” “would,” ‘could,” “should,” “may,” “remain,” “maintain,” “opportunity,” “potential,” “prepare,” “expect,” “believe,” “plan,” “future,” “belief,” “guidance,” “estimate,” “project,” “forecast” “continue,” “further” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements with respect to:
This press release includes statistical and other industry and market data that the Company obtained from industry publications and research, surveys and studies conducted by third parties or us. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. All of the market data used in this presentation involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. While the Company believes these industry publications and third-party research, surveys and studies are reliable, the Company has not independently verified such data. The industry in which the Company operates is subject to a high degree of uncertainty, change and risk due to a variety of factors, which could cause results to differ materially from those expressed in the estimates made by the independent parties and by the Company.
RECONCILIATION OF GAAP TO ADJUSTED NON-GAAP NET INCOME AND | ||||
ADJUSTED NON-GAAP EARNINGS PER SHARE (UNAUDITED) | ||||
(In thousands, except share and per share amounts) | ||||
Twelve Months Ended | ||||
2022 | ||||
Net (loss) income - GAAP | $ | 21,281 | ||
Adjustments: | ||||
Cost of product revenues: | ||||
Amortization expense | 6,561 | |||
Research and development: | - | |||
Stock-based compensation expense | 2,349 | |||
Depreciation expense | 190 | |||
Expense of acquired in-process research & development | 339 | |||
Severance | 260 | |||
Selling, general and administrative: | - | |||
Stock-based compensation expense | 14,665 | |||
Expense related to collaboration with Tyme | - | |||
Amortization expense | 203 | |||
Depreciation expense | 507 | |||
Severance | 9,594 | |||
Acquisition related costs | 12,837 | |||
Legal settlement | 300 | |||
Other: | - | |||
Non-cash interest expense | 1,270 | |||
Fair value adjustments on equity investment | 7,478 | |||
Convertible promissory note related credit losses | 5,254 | |||
Fair value adjustments related to derivative instrument | 6,823 | |||
Foreign currency exchange loss | 6,549 | |||
Inventory step-up | 392 | |||
Accretion of discount on convertible promissory note | (46 | ) | ||
Tax effect of the non-GAAP adjustments | 1,773 | |||
Adjusted non-GAAP net income | $ | 98,579 | ||
Adjusted non-GAAP earnings per share: | ||||
Basic | $ | 7.64 | ||
Diluted | $ | 7.54 | ||
Weighted average number of common shares outstanding: | ||||
Basic | 12,901,353 | |||
Diluted | 13,089,400 | |||
RECONCILIATION OF GAAP TO ADJUSTED NON-GAAP EBITDA (UNAUDITED) | ||||
(In thousands) | ||||
Twelve Months Ended | ||||
2022 | ||||
Net (loss) income - GAAP | $ | 21,281 | ||
Add back: | ||||
Interest expense, net of interest income | 2,341 | |||
Income tax provision | 28,072 | |||
Depreciation and amortization expense | 7,461 | |||
Add back: | ||||
Stock-based compensation expense | 17,014 | |||
Fair value adjustments on equity investment | 7,478 | |||
Expense of acquired in-process research & development | 339 | |||
Convertible promissory note related adjustments | 4,850 | |||
Fair value adjustments related to derivative instrument | 6,823 | |||
Foreign currency exchange loss | 6,549 | |||
Legal Settlement | 300 | |||
Acquisition related costs | 12,837 | |||
Inventory step-up | 392 | |||
Severance | 9,854 | |||
Adjusted Non-GAAP EBITDA | $ | 125,591 | ||
Important Safety Information for BYFAVO™ (remimazolam) Injection
Indications
BYFAVO is a benzodiazepine indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.
Important Safety Information
WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS
Personnel and Equipment for Monitoring and Resuscitation
- Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer BYFAVO.
- Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation.
- BYFAVO has been associated with hypoxia, bradycardia, and hypotension. Continuously monitor vital signs during sedation and during the recovery period.
- Resuscitative drugs, and age- and size-appropriate equipment for bag-valve-mask–assisted ventilation must be immediately available during administration of BYFAVO.
Risks From Concomitant Use With Opioid Analgesics and Other Sedative-Hypnotics Concomitant use of benzodiazepines, including BYFAVO, and opioid analgesics may result in profound sedation, respiratory depression, coma, and death. The sedative effect of intravenous BYFAVO can be accentuated by concomitantly administered CNS depressant medications, including other benzodiazepines and propofol. Continuously monitor patients for respiratory depression and depth of sedation.
Contraindication
BYFAVO is contraindicated in patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40.
Personnel and Equipment for Monitoring and Resuscitation
Clinically notable hypoxia, bradycardia, and hypotension were observed in Phase 3 studies of BYFAVO. Continuously monitor vital signs during sedation and through the recovery period. Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer BYFAVO. Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation. Resuscitative drugs, and age- and size-appropriate equipment for bag-valve-mask–assisted ventilation must be immediately available during administration of BYFAVO. Consider the potential for worsened cardiorespiratory depression prior to using BYFAVO concomitantly with other drugs that have the same potential (e.g., opioid analgesics or other sedative-hypnotics). Administer supplemental oxygen to sedated patients through the recovery period. A benzodiazepine reversal agent (flumazenil) should be immediately available during administration of BYFAVO.
Risks From Concomitant Use With Opioid Analgesics and Other Sedative-Hypnotics
Concomitant use of BYFAVO and opioid analgesics may result in profound sedation, respiratory depression, coma, and death. The sedative effect of IV BYFAVO can be accentuated when administered with other CNS depressant medications (eg, other benzodiazepines and propofol). Titrate the dose of BYFAVO when administered with opioid analgesics and sedative-hypnotics to the desired clinical response. Continuously monitor sedated patients for hypotension, airway obstruction, hypoventilation, apnea, and oxygen desaturation. These cardiorespiratory effects may be more likely to occur in patients with obstructive sleep apnea, the elderly, and ASA-PS class III or IV patients.
Hypersensitivity Reactions
BYFAVO contains dextran 40, which can cause hypersensitivity reactions, including rash, urticaria, pruritus, and anaphylaxis. BYFAVO is contraindicated in patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40.
Neonatal Sedation
Use of benzodiazepines during the later stages of pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) in the neonate. Observe newborns for signs of sedation and manage accordingly.
Pediatric Neurotoxicity
Published animal studies demonstrate that anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity increase neuronal apoptosis in the developing brain and result in long-term cognitive deficits when used for longer than 3 hours. The clinical significance of this is not clear. However, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester of gestation through the first several months of life but may extend out to approximately 3 years of age in humans.
Anesthetic and sedation drugs are a necessary part of the care of children needing surgery, other procedures, or tests that cannot be delayed, and no specific medications have been shown to be safer than any other. Decisions regarding the timing of any elective procedures requiring anesthesia should take into consideration the benefits of the procedure weighed against the potential risks.
Adverse Reactions
The most common adverse reactions reported in >10% of patients (N=630) receiving BYFAVO 5-30 mg (total dose) and undergoing colonoscopy (two studies) or bronchoscopy (one study) were: hypotension, hypertension, diastolic hypertension, systolic hypertension, hypoxia, and diastolic hypotension.
Use in Specific Populations
Pregnancy
There are no data on the specific effects of BYFAVO on pregnancy. Benzodiazepines cross the placenta and may produce respiratory depression and sedation in neonates. Monitor neonates exposed to benzodiazepines during pregnancy and labor for signs of sedation and respiratory depression.
Lactation
Monitor infants exposed to BYFAVO through breast milk for sedation, respiratory depression, and feeding problems. A lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk during treatment and for 5 hours after BYFAVO administration.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. BYFAVO should not be used in patients less than 18 years of age.
Geriatric Use
No overall differences in safety or effectiveness were observed between these subjects and younger subjects. However, there is a potential for greater sensitivity (eg, faster onset, oversedation, confusion) in some older individuals. Administer supplemental doses of BYFAVO slowly to achieve the level of sedation required and monitor all patients closely for cardiorespiratory complications.
Hepatic Impairment
In patients with severe hepatic impairment, the dose of BYFAVO should be carefully titrated to effect. Depending on the overall status of the patient, lower frequency of supplemental doses may be needed to achieve the level of sedation required for the procedure. All patients should be monitored for sedation-related cardiorespiratory complications.
Abuse and Dependence
BYFAVO is a federally controlled substance (CIV) because it contains remimazolam which has the potential for abuse and physical dependence.
https://bynder.acaciapharma.com/m/5d7c2cd0d58865f7/original/Barhemsys-Prescribing-Information.pdf
https://bynder.acaciapharma.com/m/403e8c343b2922de/original/Byfavo-PI.pdf
Investor Relations for
T: 212-452-2793
E: lwilson@insitecony.com
_______________________
1 Adjusted EBITDA and adjusted non-GAAP earnings per share are non-GAAP financial measures. See below for a description of non-GAAP financial measures and LTM
2 Based on management estimates for expected net price.
3 Run rate is a measure of product usage by health care providers and may not necessarily align with the timing of or amounts of recorded revenue.
4 https://investor.eagleus.com/news-releases/news-release-details/eagle-pharmaceuticals-receives-fda-approval-additional
5 Projected adjusted EBITDA is a non-GAAP financial measure. See below for a description of non-GAAP financial measures.
6 Projected adjusted non-GAAP earnings per share is a non-GAAP financial measure. See below for a description of non-GAAP financial measures.
7 Projected adjusted non-GAAP R&D expense is a non-GAAP financial measure. See below for a description of non-GAAP financial measures.
8 Based on internal estimates for expected net price.
9 Based on IQVIA and internal data for normalized period.
10 Effective
11 Launched
12 Eagle’s bendamustine franchise.
13
14
15 ENA-001 is a product candidate owned and developed by Enalare Therapeutics. Eagle has the option to acquire all of the outstanding shares of Enalare for an amount equal to approximately
16 https://investor.eagleus.com/news-releases/news-release-details/eagle-pharmaceuticals-and-enalare-therapeutics-announce
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