On May 11, 2020 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing antolimab (AK002) for the treatment of eosinophil and mast cell-related diseases, reported financial results for the first quarter ended March 31, 2020 (Press release, Allakos, MAY 11, 2020, View Source [SID1234557457]).

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First Quarter 2020 Financial Results

Research and development expenses were $18.3 million in the first quarter of 2020 as compared to $15.1 million in the same period in 2019, an increase of $3.2 million.

General and administrative expenses were $11.6 million in the first quarter of 2020 as compared to $5.8 million in the same period in 2019, an increase of $5.8 million.

Allakos reported a net loss of $27.8 million in the first quarter of 2020 as compared to $20.0 million in the same period in 2019, an increase of $7.8 million. Net loss per basic and diluted share was $0.57 for the first quarter of 2020 compared to $0.47 in the same period in 2019.

Allakos ended the first quarter of 2020 with $479.8 million in cash, cash equivalents and marketable securities.

On May 11, 2020 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its first quarter 2020 financial results and provided an update on the Company, including its first quarter progress with IPI-549, the Company’s first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition (Press release, Infinity Pharmaceuticals, MAY 11, 2020, View Source [SID1234557456]).

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"While COVID-19 has created challenges for Infinity and the broader life sciences community, it has also highlighted the dedication, commitment and innovation that is allowing the continued advancement of desperately needed treatments for patients," said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "Infinity remains committed to our clinical strategy which is designed to demonstrate the potential benefit of IPI-549 treatment for the patients in our trials who have some of the most challenging cancers and poor prognoses. It is imperative that these patients have continued access to treatment and that we advance the development of potentially promising new therapies. I am particularly proud of our team at Infinity, along with our collaborators and investigators, for prioritizing the safety of our patients while still enabling our progress in the clinic to continue. To this end, following an initial meeting with the MARIO-275 Independent Data Monitoring Committee, we are voluntarily pausing enrollment of patients in MARIO-275 to ensure patient safety while evaluating the potential benefit of IPI-549 plus Opdivo in patients with advanced urothelial cancer. The magnitude of the unmet need and the potential of IPI-549 plus Opdivo to improve outcomes for these patients is reflected in the Fast Track Designation we recently received for this combination in this patient population. Across all our studies, we are working closely with our clinical research organizations to leverage learnings from early patient enrollment and the impact of COVID-19 to address delays in new site initiation and enrollment. While the potential duration of delays in the enrollment of our trials are still being quantified, we anticipate the need for additional financial resources to fund our trials through key data readouts. We expect to provide additional updates on trial status including timelines for enrollment and data readouts as well as financial guidance by our 2Q webcast."

Key 2020 Updates:

Clinical and Regulatory:

Fast Track Designation: Infinity received Fast Track Designation from the U.S. FDA for IPI-549 in combination with the checkpoint inhibitor Opdivo for the treatment of advanced urothelial cancer.
MARIO-275: MARIO-275 is the Company’s ongoing controlled, randomized Phase 2 study evaluating IPI-549 in combination with Opdivo in platinum-refractory, I/O naïve patients with (aUC), in collaboration with Bristol Myers Squibb, or BMS. The objective of this controlled study is to evaluate the potential benefit of adding IPI-549 to Opdivo monotherapy, building on the exploratory biomarker data from the BMS CheckMate-275 study demonstrating an association between high baseline levels of myeloid-derived suppressor cells, or MDSCs, and lower median overall survival as well as Infinity’s MARIO-1 study showing that treatment with IPI-549 reduced MDSC levels in the majority of patients treated.

Independent Data Monitoring Committee (IDMC): Infinity and the MARIO-275 IDMC held the first scheduled IDMC meeting to review safety data on the initial 42 patients treated in the study. Liver enzyme elevations of Grade 3 or higher were seen in seven of 42 patients: five with Grade 3, two with Grade 4 (one is newly observed and has not yet been reviewed by the IDMC). Liver enzyme elevations from the six patients reviewed by the IDMC were reversible and have resolved without sequela. Of 17 patients evaluable for efficacy, objective responses have been observed in patients with Grade 3 and above liver enzyme elevations as well as in patients without these elevations. Infinity is continuing to review this data with the IDMC and plans to continue the treatment of patients now on study with modifications including additional patient monitoring and a dose reduction while voluntarily pausing enrollment and amending the protocol in order to ensure patient safety while evaluating the potential benefit of IPI-549 plus Opdivo.
MARIO-3: MARIO-3 is the Company’s ongoing Phase 2 study in collaboration with Roche/Genentech to evaluate IPI-549 in novel triple combination front-line therapies with Tecentriqand Abraxane in triple negative breast cancer (TNBC) and with Tecentriq and Avastin in renal cell cancer (RCC). The TNBC cohort of MARIO-3 is experiencing initial enrollment and site initiation delays, independent of a COVID-19 impact, which the Company is working closely with its CRO and investigators to evaluate.
MARIO-1: Additional data are expected in 2020 to the extent that they inform potential future IPI-549 development paths.
COVID-19: The Company is continuing to evaluate early enrollment trends in its studies as well as the impact of COVID-19 on its clinical programs. Patients enrolled on MARIO-275, MARIO-3 and MARIO-1 have continued treatment and study visits with limited disruption to date, and Infinity is working closely with trial sites to support the continued treatment of patients in compliance with study protocols. The pandemic is impacting new patient enrollment and site initiation across the Company’s clinical programs. New patient screening and enrollment and new site initiation are being assessed on a case-by-case basis and are ongoing in MARIO-3. There are no anticipated disruptions to drug supply.
Arcus Collaboration: A Phase 1b collaboration study with Arcus Biosciences, which is being conducted by Arcus, is evaluating a checkpoint-inhibitor free, novel triple-combination regimen of IPI-549 + AB928 (dual adenosine receptor antagonist) + Doxil in up to approximately 40 advanced TNBC patients.
Financial:

In January 2020, completed a $20 million asset-backed financing with BVF Partners L.P. with sole recourse in potential royalty payments due on future sales of patidegib, a hedgehog pathway inhibitor discovered by Infinity and licensed to PellePharm in 2013. In addition, Infinity is eligible to receive an additional $5 million payment from BVF based on PellePharm’s ongoing Phase 3 clinical trial of patidegib topical gel in Gorlin Syndrome. PellePharm completed enrollment of its Phase 3 trial in 2019.
Corporate:

Appointed Richard Gaynor, M.D. to Board of Directors. Richard Gaynor, M.D. was most recently the President of Research and Development for Neon Therapeutics (NasdaqGS: NTGN), a biotechnology company developing novel neoantigen-targeted T cell therapies. Prior to his tenure at Neon Therapeutics, Dr. Gaynor spent 15 years in a series of senior roles at Lilly Oncology, most recently as Senior Vice President Clinical Development and Medical Affairs.
Established Clinical Advisory Board with the following initial members:
Chair: Sam Agresta, MD, Infinity Board Member and Chief Medical Officer of Foghorn Therapeutics.
Padmanee (Pam) Sharma, MD, PhD, co-leader of the MD Anderson Cancer Center’s immunotherapy platform and T.C. and Jeanette Hsu Endowed Chair in Cell Biology, Department of Genitourinary Medical Oncology. Dr. Sharma was the principal investigator on the BMS Checkmate-275 study that first demonstrated the association of high myeloid-derived suppressor cells, or MDSCs, to significantly lower overall survival in patients with advanced urothelial cancer (aUC) that provided the inspiration for Infinity’s MARIO-275 study to which Dr Sharma brings unique insight.
Toni Choueiri, MD, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute/Brigham and Women’s Hospital and the Jerome and Nancy Kohlberg Chair and Professor of Medicine at Harvard Medical School.
Michael Postow, MD, co-leader of the Melanoma Disease Management Team at Memorial Sloan Kettering Cancer Center and assistant professor of medicine at Weill Cornell Medical College.
Updated Program and Financial Guidance:

Given that the Company is experiencing delays in MARIO-3 enrollment and site initiation and is voluntarily pausing enrollment in MARIO-275 while amending the MARIO-275 protocol to ensure patient safety, Infinity expects to provide additional updates on trial status including timelines for enrollment and data readouts as well as financial guidance by our 2Q webcast.
As a result of the delays in enrollment in its MARIO-3 and MARIO-275 clinical trials, Infinity anticipates that its existing financial resources will not be sufficient to fully fund the Company through key data readouts on all of its IPI-549 trials, and Infinity will need to find cost savings and/or seek additional capital resources in order to fund studies through key data readouts.
First Quarter 2020 Financial Results:

At March 31, 2020, Infinity had total cash, cash equivalents and available-for-sale securities of $50.3 million, compared to $42.4 million at December 31, 2019.
During the first quarter of 2020, Infinity recognized the $20 million gross proceeds from BVF, net of transaction costs, as a liability that will be amortized using the effective interest method over the life of the arrangement, in accordance with relevant accounting guidance. While recognized as a liability for accounting purposes, the Company is not obligated to repay the $20 million from BVF.
Research and development expense for the first quarter of 2020 was $7.3 million, compared to $5.8 million for the same period in 2019. The increase in R&D expense in 2020 compared to 2019 was primarily due to an increase in clinical and development activities for IPI-549.
General and administrative expense was $3.3 million for the first quarter of 2020, compared to $3.4 million for the same period in 2019.
Net loss for the first quarter of 2020 was $10.9 million, or a basic and diluted loss per common share of $0.19, compared to a net loss of $13.7 million, or a basic and diluted loss per common share of $0.24 for the same period in 2019.
2020 Financial Outlook:

Net Loss: Infinity expects net loss for 2020 to range from $40 million to $50 million.

Cash and Investments: Infinity expects to end 2020 with a year-end cash, cash equivalents and available-for-sale securities balance ranging from $15 million to $25 million.

Cash Runway: Based on its current operational plans, Infinity expects that its existing cash, cash equivalents and available-for-sale securities, will be adequate to satisfy the Company’s capital needs into 2H2021. Infinity’s financial guidance does not include potential additional funding or business development activities, a potential $5 million milestone payment from BVF based on PellePharm’s ongoing Phase 3 clinical trial of patidegib topical gel in Gorlin Syndrome, or any milestones from, or the sale of the Company’s equity interest in, PellePharm.

Conference Call Information

Infinity will host a conference call today, May 11, 2020, at 4:30 p.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity’s website at www.infi.com. To participate in the conference call, please dial (877) 316-5293 (domestic) and (631) 291-4526 (international) five minutes prior to start time. The conference ID number is 1978798. An archived version of the webcast will be available on Infinity’s website for 30 days.

On May 11, 2020 AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) reported unaudited consolidated financial results for the first quarter ended March 31, 2020 (Press release, AMAG Pharmaceuticals, MAY 11, 2020, View Source [SID1234557455]). The company reported total revenues for the first quarter of 2020 of $68.7 million, including revenue of $44.4 million from Feraheme and revenue of $21.8 million from Makena (hydroxyprogesterone caproate injection), as well as expense reductions across the business. The company also reported an operating loss of $19.6 million and an adjusted EBITDA loss of $5.5 million in the first quarter of 2020.1

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Despite strong first quarter results, AMAG’s products are being impacted by the COVID-19 pandemic as patient visits have declined during this period. Given the planned divestiture of Intrarosa (prasterone) and Vyleesi (bremelanotide injection) and the impact of COVID-19, AMAG has implemented a company-wide restructuring, which will reduce the workforce by approximately 30 percent. AMAG is withdrawing its 2020 financial guidance due to the uncertainty surrounding the duration of the COVID-19 pandemic.

"We are sharpening our focus on our priorities of maximizing Feraheme’s value, retaining patient access to Makena and continuing to efficiently develop innovative therapies, namely ciraparantag," said Scott Myers, AMAG’s president and chief executive officer. "As we look to the future, it is difficult to estimate the severity and duration of the COVID-19 pandemic. We’ve seen signs of stabilization and remain confident in the underlying demand for our products; however, we cannot speculate on the subsequent speed of recovery and the overall impact on our business."

"Based upon the extraordinary dynamics across the industry due to the COVID-19 pandemic, we have decided to withdraw our 2020 financial guidance," said Ted Myles, AMAG’s chief financial officer and chief operating officer. "We remain committed to our previously stated goal of reducing total operating expenses by more than $100 million in 2020, as compared to 2019, and we are on track to achieve this objective. Furthermore, we continue to strive towards returning to profitability this year. The work force reduction that we announced today is an important step towards achieving these corporate objectives. While it was a difficult decision, we believe the organization is now the right size to support our long-term goals. We’d like to thank our colleagues who are leaving AMAG for their many contributions to our organization."

OTHER KEY UPDATES
Leadership Transition: AMAG announced in April that its Board of Directors appointed Scott Myers as AMAG’s president and chief executive officer, and a member of the Board, effective immediately. Mr. Myers is a proven executive who brings nearly three decades of global pharmaceutical and medical technology experience to AMAG. Mr. Myers succeeds William Heiden who stepped down upon Mr. Myers’ appointment.

1

Supply Chain: At this time, all of the company’s products remain available and the supply chain has not been materially affected by COVID-19. AMAG continues to closely monitor suppliers and supply levels. The company has risk mitigation plans in place to minimize potential supply interruptions, including redundant drug substance manufacturing and inventory safety stock, and will continue to work diligently with its suppliers to maintain continuous supply as the COVID-19 situation continues to evolve.

Regulatory: In response to the company’s request to the FDA for a meeting to discuss the future of Makena, the FDA indicated that it was premature to meet at this time as it was still reviewing the matter. AMAG remains committed to working collaboratively with the FDA to maintain access to Makena for eligible pregnant women.

Clinical Trials: The COVID-19 pandemic is an evolving situation and is having a serious impact on clinical trials globally. The AMAG-423 Phase 2b/3a clinical trial is a hospital-based trial and all sites have paused new patient enrollment. The company has had to pause initiation of new sites due to the pandemic, significantly impacting recruitment and enrollment. AMAG continues to work with the FDA to initiate the ciraparantag Phase 2b trial in healthy volunteers in the U.S. However, the COVID-19 pandemic has forced the clinical trial sites where the company expected to conduct the trial to close.

FIRST QUARTER ENDED MARCH 31
Revenue
First quarter revenue totaled $68.7 million, compared to $75.8 million for the same period in 2019. This decrease was primarily due to a decrease in sales of Makena stemming from the unfavorable FDA Advisory Committee recommendation for Makena in October 2019. These decreases were partially offset by an increase in sales of Feraheme.
•Feraheme achieved first quarter revenue of $44.4 million, an increase of 11 percent over the same period last year. Feraheme’s average quarterly market share was 17.2 percent in the first quarter of 2020, compared to 16.2 percent in the first quarter of 2019.
•Makena first quarter revenue totaled $21.8 million, compared to $31.3 million in the first quarter of last year.
•Intrarosa revenue in the first quarter of 2020 totaled $3.2 million, compared to $4.4 million in the same period last year.

($M) Three Months Ended March 31, 2020 2019 Total revenues $68.7 $75.8 Feraheme 44.4 40.0 Makena 21.8 31.3 Intrarosa 3.2 4.4 Other (0.7) 0.1

Operating Expenses
Total costs and expenses decreased by $105.3 million to $88.2 million in the first quarter of 2020, as compared to the first quarter of 2019. In the first quarter of last year, the company recorded $74.9 million of acquired in-process research and development (IPR&D) expense in connection with the acquisition of Perosphere Pharmaceuticals for the development asset, ciraparantag. Also recorded in the first quarter of last year was a one-time restructuring charge of $7.4 million related to combining the company’s maternal health and women’s health sales forces in February 2019.
•Cost of products sales in the first quarter of 2020 increased by $5.9 million, as compared with the first quarter of last year, driven by an increase in amortization expense associated with the Makena, Intrarosa and Vyleesi intangible assets.
•Research and development (R&D) expenses totaled $11.2 million, compared to $18.1 million in the first quarter of last year. This decrease was primarily related to lower costs for Vyleesi following its FDA approval in June 2019.
2

•Selling, general and administrative (SG&A) expenses decreased by approximately $22.0 million, or 29 percent, in the first quarter of 2020, compared to the same period in 2019.

($M) Three Months Ended March 31, 2020 2019 Amortization of intangible assets $9.8 $3.9 Direct cost of product sales 14.5 14.5 Total cost of product sales 24.3 18.4 Research and development expenses 11.2 18.1 Acquired in-process research and development — 74.9 Selling, general and administrative expenses 52.7 74.7 Restructuring expenses — 7.4 Total costs and expenses $88.2 $193.5

Balance Sheet
•As of March 31, 2020, the company’s cash and investments totaled $124.7 million.
•Long-term debt totaled $320.0 million (representing the principal amounts outstanding of the 2022 convertible notes).

Operating Loss and Adjusted EBITDA
•The company reported an operating loss of $19.6 million in the first quarter of 2020, compared to an operating loss of $117.7 million in the same period last year.
•The company reported a loss in adjusted EBITDA of $5.5 million in the first quarter of 2020, compared to a loss in adjusted EBITDA of $26.6 million in the same period last year.

($M) Three Months Ended March 31, 2020 2019 Operating loss $(19.6) $(117.7)
Non-GAAP adjusted EBITDA1
$(5.5) $(26.6)
1 See reconciliations of GAAP to non-GAAP adjustments at the conclusion of this press release.

CONFERENCE CALL AND WEBCAST ACCESS
AMAG Pharmaceuticals, Inc. will host a conference call and webcast today at 8:00 a.m. ET to discuss the company’s first quarter 2020 financial results and recent business updates.

DIAL-IN NUMBERS
U.S./Canada Dial-in Number: (877) 412-6083
International Dial-in Number: (702) 495-1202
Conference ID: 4948155

Replay Dial-in Number: (855) 859-2056
Replay International Dial-in Number: (404) 537-3406
Conference ID: 4948155

A telephone replay will be available from approximately 11:00 a.m. ET on May 11, 2020 through midnight on May 18, 2020.

On May 11, 2020 Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, reported financial results for the first quarter ended March 31, 2020 (Press release, Applied Therapeutics, MAY 11, 2020, View Source [SID1234557454]).

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"The first quarter was a period of tremendous growth and advancement across our clinical programs," said Shoshana Shendelman, PhD, Founder, CEO and Chair of the Board of Applied Therapeutics. "We also began building out our commercial infrastructure in preparation for future launches, including Galactosemia. The company remains well capitalized as a result of the financing in January, and we look forward to continuing our momentum throughout the rest of this year – launching our pediatric study in Galactosemia, continuing enrollment on the DbCM ARISE-HF study, and advancing additional new programs forward into the clinic."

Recent Highlights

·Announced Full Data and Scientific Presentations from the Pivotal Phase 2 ACTION-Galactosemia Trial. In April 2020, we announced new data and scientific presentations from the pivotal Phase 2 ACTION-Galactosemia trial. The topline data from the trial was originally announced in early January. The full study data, originally planned to be presented at the Society for Inherited Metabolic Disorders conference, showed that once-daily 20mg/kg AT-007 rapidly and sustainably reduced toxic galactitol levels with no accompanying increase in galactose. Additionally, positive trends on MRI outcomes were shown, including indirect measures of edema, neuronal health and brain galactitol levels in AT-007-treated patients. As no drug-related adverse events were seen at the once-daily 20mg/kg dose, a once-daily 40mg/kg dose was subsequently studied in healthy volunteers, and was also shown to be safe and well-tolerated. Evaluation of the 40 mg/kg dose in Galactosemia patients remains ongoing.
·Announced IND and Investigator-Initiated Studies of AT-001 in Critical COVID-19 Patients. In April 2020, we announced that a COVID-19 IND has been opened with the FDA for AT-001, a novel potent Aldose Reductase inhibitor. Multiple AT-001 investigator-initiated trials are currently underway to address acute lung inflammation and cardiomyopathy in critical COVID-19 patients. Several New York City hospitals have initiated Emergency Investigational Drug applications for AT-001 use in critical COVID-19 patients. Additional data is being gathered through studies on the effect of AT-001 therapy in critical COVID-19 patients.
·Appointed Adam Hansard as Chief Commercial Officer. In March 2020, we announced the appointment of Adam Hansard as Chief Commercial Officer. Mr. Hansard brings extensive commercial and leadership experience across the biotech and pharmaceutical industry to Applied Therapeutics.
·Closed $143.4 Million Underwritten Public Offering. In January 2020, we completed an underwritten public offering of common stock at a price to the public of $45.50 per share, resulting in gross proceeds of approximately $143.4 million, before deducting underwriting discounts and commissions and offering expenses.

Financial Results

·Cash and cash equivalents and short-term investments totaled $154.3 million as of March 31, 2020, compared with $38.9 million at December 31, 2019.
·Research and development expenses for the three months ended March 31, 2020 were $7.3 million, compared to $6.9 million for the three months ended March 31, 2019. The increase of approximately $0.4 million was primarily related to the increase in clinical and pre-clinical expenses of $0.8 million for the advancement of clinical trials, increase in personnel-related costs of $0.2 million and $0.5 million increase in stock-based compensation expense due to an increase in headcount, which were offset by the decrease in drug manufacturing and formulation expenses of $1.0 million and decrease in regulatory and other expenses of $0.1 million.
·General and administrative expenses were $5.2 million for the three months ended March 31, 2020, compared to $1.9 million for the three months ended March 31, 2019. The increase of approximately $3.3 million was primarily related to the increase in personnel expenses and stock-based compensation of $0.4 million and $0.5 million, respectively, due to the increase in headcount, including the hiring of the chief financial officer and chief accounting officer, $1.3 million related to an increase in legal and professional fees due to increased costs associated with being a public company, and $1.2 million in other expenses relating to increased costs of insurance, rent, and other office expenses.
·Net loss for the first quarter of 2020 was $12.4 million, or $0.59 per basic and diluted common share, compared to a net loss of $8.7 million, or $1.58 per basic and diluted common share, for the first quarter 2019.

On May 11, 2020 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported financial results for the three months ended March 31, 2020 (Press release, Eagle Pharmaceuticals, MAY 11, 2020, View Source [SID1234557453]).

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Business and Recent Highlights:

·Despite the ongoing COVID-19 pandemic, the Company has not experienced any impact to its supply chain to date, and believes it has sufficient supply chain inventory to continue manufacturing and to provide product without interruption consistent with its current business plan;

·Advanced pilot work on proprietary formulation of fulvestrant product candidate, EA-114, for HR-positive advanced breast cancer, met internal objectives, and requested additional meeting with U.S. Food and Drug Administration ("FDA") to discuss regulatory path forward;

·Submitted Investigational New Drug ("IND") application to FDA for a Phase 2 clinical trial in partnership with Hackensack University Medical Center to evaluate the efficacy of RYANODEX (dantrolene sodium) in patients infected with SARS-CoV-2, the virus causing the COVID-19 pandemic;

·Favorable patent litigation decision issued by the U.S. District Court for the District of Delaware for Eagle and Teva Pharmaceutical Industries Ltd. for BENDEKA upholding the asserted patent claims as valid and infringed by the defendants’ proposed ANDA products. Defendants will be enjoined from launching their ANDA products before 2031;

·Received United States Court of Appeals for the D.C. Circuit affirmation of district court decision requiring FDA to recognize seven years of orphan drug exclusivity for BENDEKA. Accordingly, the Company does not believe other bendamustine products to treat the same indication, unless clinically superior to BENDEKA, will enter the market before 2022;

·July 8, 2020 Prescription Drug User Fee Act ("PDUFA") date for the Company’s resubmitted New Drug Application ("NDA") for RYANODEX for the treatment of exertional heat stroke ("EHS"), in conjunction with body cooling;

Page 2: Eagle Pharmaceuticals Reports First Quarter 2020 Results

·Letter requesting summary judgment of non-infringement related to vasopressin filed with the United States District Court for the District of Delaware on April 17, after May trial date was postponed due to the COVID pandemic. Eagle is the first to file an ANDA referencing VASOSTRICT, 20 units/1mL;

·SymBio, the Company’s Japanese licensing partner, announced completion of patient enrollment in its clinical trial for TREAKISYM Rapid Infusion ("RI"), a liquid bendamustine injection with a ten-minute administration time, with expected regulatory approval in the second half of 2022. Eagle is entitled to a $5 million milestone payment upon approval of either TREAKISYM Ready-to-Dilute, filed on October 7, 2019, or RI, as well as royalties and milestones that could total $10 to $25 million per year if SymBio first launches TREAKISYM RTD and then its RI product;

·Received final approval from FDA for PEMFEXY, a branded alternative to ALIMTA, following settlement of patent litigation with Eli Lilly and Company. This allows for initial market entry (equivalent to approximately a three-week supply of current ALIMTA utilization) on February 1, 2022, and a subsequent uncapped entry on April 1, 2022;

·Announced collaboration and agreement on terms for an exclusive worldwide license with the University of Pennsylvania to develop dantrolene sodium for the potential treatment of people living with Alzheimer’s disease;

·Entered into strategic collaboration with Tyme Technologies Inc. ("Tyme") to advance SM-88, a modified tyrosine derivative, for the treatment of cancer patients. Eagle made an initial investment of $20 million and will be responsible for 25% of the promotional sales efforts of SM-88 and will receive 15% royalty on net revenues of SM-88 in the United States. Tyme retains all commercial rights to SM-88 outside the U.S. and reserves the right to repurchase Eagle’s U.S. co-promotion right for $200 million; and

·Entered into a research agreement with NorthShore University HealthSystem to study RYANODEX for the treatment of traumatic brain injury, including concussion, for which there are currently no drug treatments.

Financial Highlights

·Total revenue for Q1 2020 was $46.0 million, compared to $49.8 million in Q1 2019, primarily reflecting lower product sales of BENDEKA, partially offset by higher product sales of RYANODEX and BELRAPZO.

·Net loss for Q1 2020 was $2.9 million, or ($0.21) per basic and diluted share, compared to net income for Q1 2019 of $9.0 million, or $0.64 per basic and $0.62 per diluted share.

·Adjusted non-GAAP net income for Q1 2020 was $11.7 million, or $0.86 per basic and $0.84 per diluted share, compared to adjusted non-GAAP net income for Q1 2019 of $14.6 million, or $1.05 per basic and $1.01 per diluted share.

·Cash and cash equivalents were $202.0 million, net accounts receivable was $54.5 million, and debt was $148.0 million as of March 31, 2020.

·Approved a new share repurchase program, which replaced the Company’s existing share repurchase program, providing for the repurchase of up to an aggregate of $160.0 million of the Company’s outstanding common stock.

"The momentum from late last year has continued into the first quarter of 2020, including advancing fulvestrant, receiving extended patent protection and orphan drug exclusivity affirmation for BENDEKA, and proceeding with other initiatives for RYANODEX. We believe that we are well positioned to realize the full potential of our robust portfolio of oncology and CNS/metabolic critical care products and pipeline candidates, given our strong cash flow and several potential near-term catalysts," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

Page 3: Eagle Pharmaceuticals Reports First Quarter 2020 Results

First Quarter 2020 Financial Results

Total revenue for Q1 2020 was $46.0 million, as compared to $49.8 million for Q1 2019.

Q1 2020 BELRAPZO product sales were $4.6 million, compared to $3.2 million in Q1 2019.

Q1 2020 RYANODEX product sales were $11.4 million, compared to $4.0 million in Q1 2019.

Royalty revenue was $28.3 million in the first quarter of 2020, compared to $26.3 million in the first quarter of 2019. BENDEKA royalties were $28.0 million in the first quarter of 2020, compared to $26.0 million in the first quarter of 2019. A summary of total revenue is outlined below:

Gross margin was 83% during the first quarter of 2020, as compared to 74% in the first quarter of 2019. The expansion in gross margin in the first quarter of 2020 was driven by an increase in RYANODEX product sales, lower BENDEKA product sales in the period to the Company’s marketing partner, on which Eagle earns no profit, and the increase in BENDEKA royalty revenue.

R&D expense was $9.4 million for the first quarter of 2020, compared to $6.4 million in the first quarter of 2019. The year-over-year increase is largely attributable to spending related to its fulvestrant product candidate as well as payroll expenses. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the first quarter of 2020 was $7.8 million.

SG&A expense in the first quarter of 2020 increased to $24.8 million compared to $18.1 million in the first quarter of 2019. External legal spend, external sales and marketing spend, and stock-based compensation expense, as well as a $2.5 million expense related to the collaboration with Tyme, account for most of the year-over-year increase. Excluding stock-based compensation and other non-cash and non-recurring items, first quarter 2020 SG&A expense was $15.5 million.

Net loss for the first quarter of 2020 was $2.9 million, or ($0.21) per basic and diluted share, compared to net income of $9.0 million, or $0.64 per basic and $0.62 per diluted share, in the first quarter of 2019.

Adjusted non-GAAP net income for the first quarter of 2020 was $11.7 million, or $0.86 per basic and $0.84 per diluted share, compared to adjusted non-GAAP net income of $14.6 million or $1.05 per basic and $1.01 per diluted share in the first quarter of 2019. For a full reconciliation of adjusted non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release.

Page 4: Eagle Pharmaceuticals Reports First Quarter 2020 Results

2020 Expense Guidance

·R&D spend in 2020, on a non-GAAP basis, is expected to be $46-$50 million, as compared to $31 million in 2019.

·SG&A spend in 2020, on a non-GAAP basis, is expected to be $61-$64 million, as compared to $56 million in 2019.

The guidance provided in this section represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward-Looking Statements section of this press release.

Liquidity

As of March 31, 2020, the Company had $202.0 million in cash and cash equivalents plus $54.5 million in net accounts receivable, $34.5 million of which was due from Teva. The Company had $148 million in outstanding debt, including $110.0 million drawn on its revolving credit facility. Therefore, at March 31, 2020, the Company had net cash plus receivables of $108.5 million. Since March 31, the Company has re-paid the full $110.0 million drawn under its revolving credit facility.

On March 17, 2020, the Company announced that Eagle’s Board of Directors approved a new share repurchase program, which replaced the Company’s existing share repurchase program providing for the repurchase of up to an aggregate of $160.0 million of the Company’s outstanding common stock. In the first quarter of 2020, the Company repurchased $1.0 million of Eagle’s common stock as part of the share repurchase program. From August 2016 through March 31, 2020, the Company repurchased $172.9 million of its common stock.

Conference Call

As previously announced, Eagle management will host its first quarter 2020 conference call as follows:

Date Monday, May 11, 2020
Time 8:30 A.M. ET
Toll free (U.S.) 877-876-9173
International 785-424-1667
Webcast (live and replay) www.eagleus.com, under the "Investor + News" section

Participants should dial in 15 minutes prior to the start of the call to ensure timely access.

A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-6803 (US) or 402-220-6056 (International) and entering conference call ID EGRXQ120. The webcast will be archived for 30 days at the aforementioned URL.