Form 8-K Baudax Bio, Inc. For: May 05

Exhibit 99.1

 

Baudax Bio Reports First Quarter 2021 Financial Results

ANJESO^® Demonstrates Continued Progress with Launch; Growth in End-User Unit Sales Increased 40% in Q1 compared to Q4’20

Average Sales per Account Increased 30% in Q1 compared to Q4’20

Richard S. Casten Strengthens Management Team in Chief Financial Officer Role

Management to Host Investor Conference Call and Webcast Today at 8:00 a.m. ET

 

MALVERN, Pa., May 5, 2021 -- Baudax Bio, Inc. (NASDAQ: BXRX) (the “Company”), a pharmaceutical company focused on developing and commercializing innovative products for acute care settings, today reported financial results for the three months ended March 31, 2021.

 

“The first quarter has been busy and fruitful at Baudax. ANJESO sustained marked progress in the areas of new account wins, increasing units sold, reorder rates, and deepening usage across the hospital and ambulatory surgery center space. Although we are seeing some relief from COVID in the marketplace, it continues to impact elective surgical procedures and hospital administration’s focus as well as access into accounts, which the team will need to continue to monitor to maintain the growth of ANJESO.” said Gerri Henwood, President and CEO of Baudax Bio. “We continue to receive positive feedback from physicians using ANJESO for the management of moderate to severe pain in the acute care setting.”

First Quarter 2021 and Recent Business Highlights

 

During the first quarter, formulary wins grew by 22 institutions, for a total of 90 institutions as of March 31, 2021, an increase of over 30% from the fourth quarter.

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First Quarter 2021 Financial Results

As of March 31, 2021, Baudax Bio had cash, cash equivalents and short-term investments of $38.2 million.

Net product revenue for the three months ended March 31, 2021 was $0.2 million, related to sales of ANJESO in the U.S. There was no product revenue recognized during the three months ended March 31, 2020.

Cost of sales for the three months ended March 31, 2021 was $0.8 million and consisted of product costs, royalty expense and certain fixed costs associated with the manufacturing of ANJESO including supply chain and quality costs. Certain product costs of ANJESO units recognized as revenue during the three months ended March 31, 2021 were incurred prior to the FDA approval of ANJESO in February 2020, and therefore are not included in cost of sales during the period. Baudax Bio expects that over time, its cost of sales will increase as sales increase and as inventory values change to include all direct and indirect costs and expenses post FDA approval. No cost of sales was recorded for the three months ended March 31, 2020.

Research and development expenses for the three months ended March 31, 2021 were $1.1 million, compared to $3.1 million for the three months ended March 31, 2020. The decrease of $2.0 million was primarily due to a decrease of $1.7 million as a result of re-allocating costs related to supply chain, regulatory, quality, and medical affairs associated with support of the commercial launch of ANJESO from research and development expense to cost of sales and selling, general and administrative expense and a decrease in personnel costs of $0.3 million.

Selling, general and administrative expenses for the three months ended March 31, 2021 were $12.1 million, compared to $8.0 million for the same prior year period. The increase of $4.1 million was primarily due to the commercial launch of ANJESO, specifically, an increase in personnel related costs of $1.6 million, an increase of $1.3 million attributable to medical affairs and regulatory support reallocated from research and development expense post FDA approval, an increase of $0.3 million in public company costs and an increase of $0.3 million in marketing costs. In addition, the first quarter of 2020 included $0.5 million in reimbursed general and administrative expenses related to the Transition Services Agreement with Recro Pharma, which ended on December 31, 2020.

Baudax Bio reported a net loss, including non-cash charges of $5.1 million, of $16.9 million, or $(0.27) per share, for the three months ended March 31, 2021. The non-cash charge of $5.1 million was associated with stock-based compensation, non-cash interest expense, depreciation, amortization, changes in warrant valuations, and changes in fair value of contingent consideration. This compares to a net loss, including non-cash charges of $32.0 million, of $40.3 million, or $(4.03) per share, for the comparable period in 2020. The non-cash charge of $32.0 million in 2020 was associated with changes in fair value of contingent consideration, stock-based compensation, change in warrant valuation, depreciation and amortization.

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on developing and commercializing innovative products for acute care settings. The launch of Baudax Bio’s first commercial product ANJESO® began in mid-2020. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain, which can be administered alone or in combination with other non-NSAID analgesics. It has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and a Phase IIIb program evaluating ANJESO and its health economic impact in specific surgical settings. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies. For more information, please visit www.baudaxbio.com.

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Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend,” and “expect,” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio’s ability to maintain regulatory approval for ANJESO, Baudax Bio’s ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio’s ability and that of Baudax Bio’s third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio’s ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio’s ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio’s ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio’s ability to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio’s estimates of the potential market for ANJESO, Baudax Bio’s ability to achieve its financial goals; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio’s business and future results included in Baudax Bio’s filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

CONTACTS:  

Investor Relations Contact:

Argot Partners

Sam Martin / Claudia Styslinger

(212) 600-1902

[email protected]

[email protected]  

 

Media Contact:

Argot Partners

David Rosen

(212) 600-1902

[email protected]

 

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BAUDAX BIO, INC.

Consolidated Balance Sheets

(Unaudited)

 

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BAUDAX BIO, INC.

Consolidated and Combined Statements of Operations

(Unaudited)

 

 

 

 

Q1 2021 Financial Results May 5, 2021

Forward Looking Statements This presentation contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend,” and “expect,” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the completion of the registered direct offering and the intended use of proceeds from the registered direct offering, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio’s ability to maintain regulatory approval for ANJESO, Baudax Bio’s ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio’s ability and that of Baudax Bio’s third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio’s ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio’s ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio’s ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio’s ability to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio’s estimates of the potential market for ANJESO, Baudax Bio’s ability to achieve its financial goals; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio’s business and future results included in Baudax Bio’s filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

Income Statement – Q1’21 versus Q1’20 Q1 2021 highlights: Revenue & Cost of sales from sales of ANJESO Increased selling, marketing and support expenses for continued support towards ANJESO commercial launch Continued to navigate though on-going COVID-19 challenges throughout the quarter For the Three Months Ended March 31, Year over Year (amounts in thousands) 2021 2020 Change Revenue, net $ 198    $ —     $ 198    Operating expenses: Cost of sales (excl. amortization of intangible assets) 821    —     821    Research and development 1,108    3,070    (1,962)   Selling, general and administrative 12,088    8,046    4,042    Amortization of intangible assets 644    215    429    Change in warrant valuation 18    1,378    (1,360)   Change in contingent consideration valuation 1,841    27,626    (25,785)   Total operating expenses 16,520    40,335    (23,815)   Operating loss (16,322)   (40,335)   24,013    Other income (expense): Interest and other expense (590)   37    (627)   Net loss $ (16,912)   $ (40,298)   $ 23,386   

Baudax Bio: Q1’21 Anjeso Status Update Launch Progress is being made despite varying levels of COVID-19 disruption of account access, formulary meetings, and elective surgeries Vials sold grew ~40% in Q1’21 compared to Q4’20 Sales to existing hospitals and ASC accounts doubled from Q4’20 to Q1’21 End user reorders at a 59% rate in Q1’21

Sales continue to show quarter over quarter growth into Q1 of 2021 (40% growth vs. Q4’20)

59% of End Customers Reordered in Q1’21 (Nearly 70% of customers with 3+ units have reordered since launch) Sales to existing Hospitals & ASCs doubled from Q4’20 to Q1’21 * Q3’20 was first quarter of full commercial launch. NPP = non-personal promotion

Current team focused on developing advocacy, P&T submissions and pull through with core customer. Added +3 territories in Q1 Baudax Field Teams Deployed virtual reps in December for outreach to hospitals not currently targeted Tele Sales: Extend Hospital Reach Surgical & Medical Device Consultants engaged to accelerate access and uptake with targeted customers and accounts Currently 15 TAs supporting access Territory Advisors Accelerate Access Deployed virtual Ortho reps in late January with previous relationships to expand access and reach in Orthopedics Tele Sales: Extend Ortho Reach Cost-Effective & Innovative Approach Continues

Commercial Launch Highlights Q1’21 Increasing Awareness In A Cost-Efficient Way Vial Use Growing Quarterly ANJESO ‘On Formulary’ at approximately 90 accounts at the end of Q1 Largest areas of usage remains hard tissue procedures including orthopedics, and podiatry; plastic surgery and soft tissue procedures gaining momentum COVID Continue to Impact Rate of Update COVID-19 continues to impact customer access and delays in formulary reviews Delays in order set implementation has also impacted faster growth in ‘On Formulary’ accounts NPP = non-personal promotion Field focused remains on formulary reviews, pull-through & expanding usage within accounts Team supplemented with tele-sales team, territory advisors & hyper-targeted NPP Internal teams expanded to support areas where momentum has developed

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