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Albireo Pharma, Inc. (ALBO) SEC Filing 10-Q Quarterly Report for the period ending Thursday, March 31, 2022

SEC Filings

ALBO Quarterly Reports

Albireo Pharma, Inc.

CIK: 1322505 Ticker: ALBO

Exhibit 99.1

 

 

Albireo Reports Q4 and Year-End 2021 Financial Results and Business Update

 

BylvayTM (odevixibat) launched in the U.S. and Europe, 2021 product revenue, net $7 million

 

NICE endorses clinical and economic benefits of Bylvay

 

Phase 3 study in Alagille syndrome on track for readout in 2022

 

Reports $248.1 million of cash and cash equivalents, sufficient to fund operations into 2024

 

Company to host a conference call and webcast today at 10:00 a.m. ET

 

BOSTON — March 1, 2022 — Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company developing novel bile acid modulators, today provided a business update and reported financial results for the fourth quarter and year ended December 31, 2021.

 

“The response to Bylvay from healthcare providers, patients and payors has been positive. As a result, we are pleased to have generated a significant number of patient starts that resulted in sales at the higher end of our 2021 guidance,” said Ron Cooper, President and Chief Executive Officer of Albireo. “For 2022, we look forward to increased Bylvay sales with launches in additional countries, completing enrollment in the two ongoing Phase 3 studies in Alagille syndrome and biliary atresia, and initiating clinical studies for both our novel/innovative pipeline compounds for adult liver and viral diseases.”

 

2021 and Upcoming Highlights

 

Bylvay (odevixibat)

 

Bylvay Launch Metrics  Full Year 2021   Q4   Q3 
Net Sales  $7.0M 
($5.3M U.S., $1.7M Intl)​
   $5.9M
($4.5M U.S., $1.4M Intl)
   $1.1M
($0.8M U.S., $0.3M Intl)
 
Prescriptions (NRx)   93    65    28 

Patients on Bylvay (Approved & reimbursed)

   53    39    14 
Potential Rollover Patients   ~90    ~90    100 

Unique Prescribers Cumulative (U. S. only)

   51    51    19 

 

·Bylvay was approved by the U.S. Food & Drug Administration (FDA) on July 20, 2021 and launched as the first drug for the treatment of pruritus in patients 3 months of age and older in all types of progressive familial intrahepatic cholestasis (PFIC).

 


The following information was filed by Albireo Pharma, Inc. (ALBO) on Tuesday, March 1, 2022 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Albireo Pharma, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2022 10-K Annual Report includes:

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Inside Albireo Pharma, Inc.'s 10-Q Quarterly Report:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Document And Entity Information
Condensed Consolidated Balance Sheets
Condensed Consolidated Balance Sheets (Parenthetical)
Condensed Consolidated Statements Of Cash Flows
Condensed Consolidated Statements Of Comprehensive Loss
Condensed Consolidated Statements Of Operations
Condensed Consolidated Statements Of Shareholders' Equity
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Commitments And Contingencies - Agreements With Cros (Details)
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Equity Financings (Details)
Fair Value Of Financial Instruments
Fair Value Of Financial Instruments (Details)
Fair Value Of Financial Instruments (Tables)
Income Taxes
Inventory
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Inventory (Tables)
Net Loss Per Share
Net Loss Per Share (Tables)
Net Loss Per Share - Anti-Dilutive Shares (Details)
Net Loss Per Share - Basic And Diluted Eps (Details)
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Note Payable (Tables)
Note Payable - Carrying Value (Details)
Note Payable - Estimated Future Principal Payments (Details)
Note Payable - Loan And Security Agreement (Details)
Note Payable - Warrants (Details)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Stock-Based Compensation Activity (Details)
Stock-Based Compensation - Stock-Based Compensation Expense (Details)
Summary Of Significant Accounting Policies And Basis Of Presentation
Summary Of Significant Accounting Policies And Basis Of Presentation (Policies)
Summary Of Significant Accounting Policies And Basis Of Presentation (Tables)
Summary Of Significant Accounting Policies And Basis Of Presentation - Inventory (Details)
Summary Of Significant Accounting Policies And Basis Of Presentation - Monetization Of Future Royalties (Details)
Summary Of Significant Accounting Policies And Basis Of Presentation - Organization (Details)
Summary Of Significant Accounting Policies And Basis Of Presentation - Revenue Recognition (Details)
Summary Of Significant Accounting Policies And Basis Of Presentation - Trade Receivables (Details)

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Albireo Pharma, Inc. provided additional information to their SEC Filing as exhibits

Ticker: ALBO
CIK: 1322505
Form Type: 10-Q Quarterly Report
Accession Number: 0001558370-22-008984
Submitted to the SEC: Mon May 16 2022 4:40:27 PM EST
Accepted by the SEC: Mon May 16 2022
Period: Thursday, March 31, 2022
Industry: Pharmaceutical Preparations

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