On May 11, 2020 Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata," the "Company," or "we"), a clinical-stage biopharmaceutical company, reported financial results for the quarter ended March 31, 2020, and provided an update on the Company’s business and product development programs (Press release, Reata Pharmaceuticals, MAY 11, 2020, View Source [SID1234557609]).

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Recent Company Highlights

Reata recently announced changes to its clinical programs and operations as a result of the COVID-19 pandemic. For each clinical development program, Reata developed and implemented changes designed to mitigate risk to patients; comply with regulatory, institutional, and government guidance; and maintain the integrity of our ongoing clinical studies. At this time, we expect that data collection for the ongoing CARDINAL study of bardoxolone methyl (bardoxolone) in chronic kidney disease caused by Alport syndrome will not be significantly impacted by the COVID-19 pandemic. We have observed no significant data loss during this period.

When the FALCON trial for bardoxolone in ADPKD was paused in March, we implemented adjustments similar to those implemented for CARDINAL. We have observed no significant data loss in the FALCON trial to date. For the FALCON study, we have been able to continue treatment of patients enrolled in the study, but because in-clinic visits are necessary to enroll new patients, we have had to pause enrollment of new patients into the study. Clinical trial sites are starting to reopen, and we are hopeful that we may be able to resume screening of patients for FALCON as early as this quarter at some sites.

Additionally, we do not believe that the COVID-19 pandemic will have a significant impact on our ability to execute on the planned New Drug Application submissions for bardoxolone in Alport syndrome or omaveloxolone in Friedreich’s ataxia.

First Quarter Financial Highlights

Cash and Cash Equivalents

On March 31, 2020, we had cash and cash equivalents of $624.5 million, as compared to $664.3 million at December 31, 2019.

Collaboration Revenue

Collaboration Revenue was $1.4 million in the first quarter of 2020, as compared to $7.8 million for the same period of the year prior. Revenue for the first quarter of 2020 included $1.2 million from the Kyowa Kirin Co., Ltd. license agreement and $0.2 million from other sources.

GAAP and Non-GAAP Research and Development (R&D) Expenses

R&D expenses according to generally accepted accounting principles in the U.S. (GAAP) were $47.7 million for the first quarter of 2020, as compared to $26.1 million for the same period of the year prior.

Non-GAAP R&D expenses were $36.1 million for the first quarter of 2020, as compared to $24.4 million for the same period of the year prior.1

GAAP and Non-GAAP General and Administrative (G&A) Expenses

GAAP G&A expenses were $20.8 million for the first quarter of 2020, as compared to $10.0 million for the same period of the year prior.

Non-GAAP G&A expenses were $13.0 million for the first quarter of 2020, as compared to $7.5 million for the same period of the year prior.1

GAAP and Non-GAAP Net Loss

The GAAP net loss for the first quarter of 2020 was $48.9 million, or $1.47 per share, on both a basic and diluted basis, as compared to a GAAP net loss of $29.2 million, or $0.98 per share, on both a basic and diluted basis, for the same period of the year prior.

The increase in GAAP net loss is driven primarily by an increase in expenses, offset by an income tax benefit. Higher expenses were driven by an increase in research and development activities, including personnel-related costs to support this growth. Under the provisions of the Coronavirus Aid, Relief, and Economic Security Act (the "CARES Act"), we recognized a tax benefit of $22.1 million.

The non-GAAP net loss for the first quarter of 2020 was $29.6 million, or $0.89 per share on both a basic and diluted basis, as compared to a non-GAAP net loss of $24.9 million, or $0.84 per share, on both a basic and diluted basis, for the same period of the year prior.1

Reiterates Cash Guidance

The Company reiterated that it expects existing cash and cash equivalents to be sufficient to enable it to fund operations through the end of 2021.

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1 See "Use of Non-GAAP Financial Measures" below for a description of non-GAAP financial measures and a reconciliation between GAAP and non-GAAP R&D expenses, GAAP and non-GAAP G&A expenses, and GAAP and non-GAAP net loss, respectively, appearing later in the press release.

Non-GAAP Financial Measures

This press release contains non-GAAP financial measures, including non-GAAP R&D expenses, non-GAAP G&A expenses, non-GAAP operating expenses, non-GAAP net loss and non-GAAP net loss per common share – basic and diluted. These measures are not in accordance with, or an alternative to, GAAP, and may be different from non-GAAP financial measures used by other companies.

The Company defines non-GAAP R&D expenses as GAAP R&D expenses less stock-based compensation expense, non-GAAP G&A expenses as GAAP G&A expenses less stock-based compensation expense, non-GAAP operating expenses as GAAP operating expenses less stock-based compensation expense and reacquired license rights expense, non-GAAP net loss as GAAP net loss plus stock-based compensation expense and reacquired license rights expense, and non-GAAP net loss per common share – basic and diluted as GAAP net loss per common share – basic and diluted plus stock-based compensation expense and reacquired license rights expense. During the three months ended March 31, 2020 and 2019, the Company did not incur any reacquired license rights expense; therefore, this expense is not included in the reconciliations below for the measures for non-GAAP operating expenses, non-GAAP net loss, and non-GAAP net loss per common share – basic and diluted for these periods. The Company has excluded the impact of stock-based compensation expense, which may fluctuate from period to period based on factors including the variability associated with performance-based grants for stock options and restricted stock units and changes in the Company’s stock price, which impacts the fair value of these awards. The Company has excluded the impact of reacquired license rights expense because the Company believes its impact makes it difficult to compare its results to prior periods and anticipated future periods.

Because management believes certain items such as stock-based compensation expense and reacquired license rights expense can distort the trends associated with the Company’s ongoing performance, the following measures are often provided, excluding special items, and utilized by the Company’s management, analysts, and investors to enhance consistency and comparability of year-over-year results, as well as to industry trends, and to provide a basis for evaluating operating results in future periods: non-GAAP net loss; non-GAAP net loss per common share – basic and diluted; non-GAAP R&D expenses; non-GAAP G&A expenses; and non-GAAP operating expenses.

The Company believes the presentation of these non-GAAP financial measures provides useful information to management and investors regarding the Company’s financial condition and results of operations. When GAAP financial measures are viewed in conjunction with these non-GAAP financial measures, investors are provided with a more meaningful understanding of the Company’s ongoing operating performance and are better able to compare the Company’s performance between periods. In addition, these non-GAAP financial measures are among those indicators the Company uses as a basis for evaluating performance, allocating resources and planning and forecasting future periods. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between these non-GAAP measures and the most directly comparable GAAP measures is provided later in this press release.

Conference Call Information

Reata’s management will host a conference call on May 11, 2020 at 4:30 PM ET. The conference call will be accessible by dialing (844) 348-3946 or (213) 358-0892 (international) using the access code: 6936548. The webcast link is View Source

First quarter 2020 financial results to be discussed during the call will be included in an earnings press release that will be available on the company’s website shortly before the call at View Source and will be available for 12 months after the call. The audio recording and webcast will be accessible for at least 90 days after the event at View Source.

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.

On May 11, 2020 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, reported that Shalini Sharp, the company’s Chief Financial Officer, will hold a virtual presentation at the BofA Securities Global Health Care Conference on Thursday, May 14, 2020 at 10:20 AM ET (Press release, Ultragenyx Pharmaceutical, MAY 11, 2020, View Source [SID1234557491]).

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The live and archived webcast of the presentation will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.

On May 11, 2020 Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel coronavirus COVID-19 vaccine, reported an update on its Phase 2 trial of its T-cell activating HS-110, in combination with Opdivo (nivolumab) in advanced non-small cell lung cancer (NSCLC) (Press release, Heat Biologics, MAY 11, 2020, View Source [SID1234557519]).

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Recent highlights:

American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) poster presentation on "Tumor antigen expression and survival of patients with previously treated advanced non-small cell lung cancer (NSCLC) receiving viagenpumatucel-L (HS-110) plus nivolumab" on May 29th presenting latest survival data of HS-110 in combination with nivolumab in previously treated, immunotherapy naïve patients with advanced non-small cell lung cancer (NSCLC)
Established partnership for biomarker development with Earle A. Chiles Research Institute of the Providence Cancer Institute in Portland, Oregon
Plan to initiate Type B end of Phase 2 meeting with the FDA to discuss registration strategy
Jeff Wolf, Chief Executive Officer of Heat, commented, "We continue to make good progress on our clinical-stage portfolio, as well as our COVID-19 vaccine platform, and look forward to presenting additional HS-110 data on May 29 at ASCO (Free ASCO Whitepaper). Additionally, we are excited to proceed with our partnership for biomarker development with the Providence Cancer Institute to find a tissue-based marker that will help predict patient treatment response with HS-110 and nivolumab. Finally, we are in the process of preparing a data package for an End of Phase 2 Meeting (EOP2) with the FDA. This meeting will represent an important milestone in finalizing our registrational strategy for HS-110. We are highly encouraged by the data thus far and look forward to providing the latest study results at ASCO (Free ASCO Whitepaper)."

On May 11, 2020 BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) reported that it intends to offer, subject to market conditions and other factors, $500.0 million aggregate principal amount of senior subordinated convertible notes due 2027 in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (Press release, BioMarin, MAY 11, 2020, View Source [SID1234557538]). BioMarin also intends to grant the initial purchasers of the notes a 13-day option to purchase up to an additional $50.0 million aggregate principal amount of notes.

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The notes will be general senior subordinated, unsecured obligations of BioMarin and will accrue interest payable semi-annually in arrears. The notes will be convertible into shares of BioMarin’s common stock. The interest rate, initial conversion rate and other terms of the notes will be determined at the time of pricing of the offering.

BioMarin intends to use up to $50.0 million of the net proceeds from the offering to repurchase shares of its common stock either concurrently with the offering in privately negotiated transactions with purchasers of the notes effected through one of the initial purchasers or its affiliate, as BioMarin’s agent, or following the offering in privately negotiated or other repurchase transactions. BioMarin intends to use a majority of the net proceeds from the offering to repay, repurchase or settle in cash some or all of its 1.50% senior subordinated convertible notes due in 2020, although it does not intend to effect any such repayment, repurchase or settlement concurrently with the offering. BioMarin intends to use the remainder of the net proceeds for general corporate purposes.

The offer and sale of the notes and the shares of BioMarin common stock issuable upon conversion of the notes have not been registered under the Securities Act or any state securities laws, and unless so registered, the notes and such shares may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

This press release is neither an offer to sell nor a solicitation of an offer to buy any securities, nor shall it constitute an offer, solicitation or sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.