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TABLE OF
CONTENTS
TABLE OF
CONTENTS
Table of
Contents
Filed
pursuant to Rule 424B5
Registration No. 333-238063
Prospectus
Supplement
(To Prospectus dated
May 18, 2020)
4,000,000 Shares

Common Stock
We are offering
4,000,000 shares of our common stock. Our common stock is listed on
The Nasdaq Capital Market under the symbol "ALBO." The last
reported sale price of our common stock on The Nasdaq Capital
Market on September 9, 2020 was $41.61 per share.
Investing in our
common stock involves a high degree of risk. Please read "Risk
Factors" beginning on page S-9 of this prospectus supplement,
page 5 of the accompanying prospectus and under similar
headings in the documents that are incorporated by reference into
this prospectus supplement and the accompanying
prospectus.
Neither the
Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or
passed upon the adequacy or accuracy of this prospectus supplement
or the accompanying prospectus. Any representation to the contrary
is a criminal offense.
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Per Share |
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Total |
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Public offering price
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$ |
40.00 |
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$ |
160,000,000 |
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Underwriting discounts and
commissions(1)
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$ |
2.40 |
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$ |
9,600,000 |
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Proceeds to us before expenses
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$ |
37.60 |
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$ |
150,400,000 |
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- (1)
- We have agreed to
reimburse the underwriters for certain expenses. See "Underwriting"
beginning on page S-24 of this prospectus supplement for
additional information regarding underwriter
compensation.
Delivery of the shares
of common stock is expected to be made on or about
September 14, 2020. We have granted the underwriters an option
for a period of 30 days to purchase up to an additional
600,000 shares of our common stock. If the underwriters exercise
the option in full, the total underwriting discounts and
commissions payable by us will be $11,040,000, and the total
proceeds to us, before expenses, will be $172,960,000.
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Joint Bookrunning Managers |
Cowen |
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William Blair |
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Co-Managers |
Wedbush PacGrow |
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H.C. Wainwright & Co. |
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Baird |
Prospectus supplement dated September 9, 2020.
Table of
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TABLE OF CONTENTS
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PROSPECTUS SUPPLEMENT
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ABOUT THIS PROSPECTUS SUPPLEMENT
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PROSPECTUS SUPPLEMENT SUMMARY
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S-1 |
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THE OFFERING
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RISK FACTORS
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SPECIAL NOTE REGARDING FORWARD-LOOKING
STATEMENTS
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USE OF PROCEEDS
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DIVIDEND POLICY
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CAPITALIZATION
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DILUTION
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MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO
NON-U.S. HOLDERS
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UNDERWRITING
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LEGAL MATTERS
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S-31 |
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EXPERTS
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WHERE YOU CAN FIND MORE INFORMATION
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INCORPORATION OF DOCUMENTS BY REFERENCE
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PROSPECTUS
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ABOUT THIS PROSPECTUS
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PROSPECTUS SUMMARY
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RISK FACTORS
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SPECIAL NOTE REGARDING FORWARD-LOOKING
STATEMENTS
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USE OF PROCEEDS
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PLAN OF DISTRIBUTION
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DESCRIPTION OF COMMON STOCK
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DESCRIPTION OF PREFERRED STOCK
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DESCRIPTION OF DEBT SECURITIES
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DESCRIPTION OF WARRANTS
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DESCRIPTION OF RIGHTS
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DESCRIPTION OF UNITS
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CERTAIN PROVISIONS OF DELAWARE LAW AND OF THE
COMPANY'S CERTIFICATE OF INCORPORATION AND BYLAWS
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LEGAL MATTERS
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EXPERTS
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WHERE YOU CAN FIND MORE INFORMATION
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INCORPORATION OF DOCUMENTS BY REFERENCE
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Table of
Contents
ABOUT THIS PROSPECTUS
SUPPLEMENT
This prospectus
supplement and the accompanying prospectus are part of a "shelf"
registration statement on Form S-3 (File No. 333-238063)
that we filed with the Securities and Exchange Commission, or SEC,
on May 7, 2020, and that was declared effective by the SEC on
May 18, 2020. This document is in two parts. The first part is
this prospectus supplement, which describes the specific terms of
this common stock offering and also adds to and updates information
contained in the accompanying prospectus and the documents
incorporated by reference herein. The second part, the accompanying
prospectus, including the documents incorporated by reference
therein, provides more general information. Generally, when we
refer to this prospectus, we are referring to both parts of this
document combined. To the extent there is a conflict between the
information contained in this prospectus supplement and the
information contained in the accompanying prospectus or any
document incorporated by reference therein filed prior to the date
of this prospectus supplement, you should rely on the information
in this prospectus supplement; provided that if any statement in
one of these documents is inconsistent with a statement in another
document having a later date—for example, a document incorporated
by reference in the accompanying prospectus—the statement in the
document having the later date modifies or supersedes the earlier
statement.
We further note
that the representations, warranties and covenants made by us in
any agreement that is filed as an exhibit to any document that is
incorporated by reference herein were made solely for the benefit
of the parties to such agreement, including, in some cases, for the
purpose of allocating risk among the parties to such agreements,
and should not be deemed to be a representation, warranty or
covenant to you. Moreover, such representations, warranties or
covenants were accurate only as of the date when made. Accordingly,
such representations, warranties and covenants should not be relied
on as accurately representing the current state of our
affairs.
You should rely
only on the information contained in this prospectus supplement or
the accompanying prospectus, or incorporated by reference herein.
We have not authorized, and the underwriters have not authorized,
anyone to provide you with information that is different. The
information contained in this prospectus supplement or the
accompanying prospectus, or incorporated by reference herein is
accurate only as of the respective dates thereof, regardless of the
time of delivery of this prospectus supplement and the accompanying
prospectus or of any sale of our common stock. It is important for
you to read and consider all information contained in this
prospectus supplement and the accompanying prospectus, including
the documents incorporated by reference herein and therein, in
making your investment decision. You should also read and consider
the information in the documents to which we have referred you in
the sections entitled "Where You Can Find More Information" and
"Incorporation of Documents by Reference" in this prospectus
supplement and in the accompanying prospectus.
We are offering
to sell, and seeking offers to buy, shares of our common stock only
in jurisdictions where offers and sales are permitted. The
distribution of this prospectus supplement and the accompanying
prospectus and the offering of the common stock in certain
jurisdictions may be restricted by law. Persons outside the United
States who come into possession of this prospectus supplement and
the accompanying prospectus must inform themselves about, and
observe any restrictions relating to, the offering of the common
stock and the distribution of this prospectus supplement and the
accompanying prospectus outside the United States. This prospectus
supplement and the accompanying prospectus do not constitute, and
may not be used in connection with, an offer to sell, or a
solicitation of an offer to buy, any securities offered by this
prospectus
S-i
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supplement and the
accompanying prospectus by any person in any jurisdiction in which
it is unlawful for such person to make such an offer or
solicitation.
Unless the
context otherwise requires, all references in this prospectus
supplement and the accompanying prospectus to "the Company," "we,"
"us," "our" and similar terms refer to Albireo Pharma, Inc.
and its direct and indirect subsidiaries.
S-ii
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PROSPECTUS SUPPLEMENT SUMMARY
This
summary highlights information contained elsewhere or incorporated
by reference in this prospectus supplement and the accompanying
prospectus. This summary does not contain all of the information
that you should consider before deciding to invest in our common
stock. You should read this entire prospectus supplement and the
accompanying prospectus carefully, including the "Risk Factors"
section contained in this prospectus supplement, our consolidated
financial statements and the related notes thereto and the other
documents and information incorporated by reference in this
prospectus supplement and the accompanying
prospectus.
Overview
We are a
biopharmaceutical company focused on the development and
commercialization of novel bile acid modulators to treat orphan
pediatric liver diseases and other liver or gastrointestinal
diseases (GI) and disorders. We are pursuing the development of our
lead product candidate, odevixibat (formerly known as A4250), for
patients with progressive familial intrahepatic cholestasis, or
PFIC, a rare, life-threatening genetic disorder affecting young
children for which there is currently no approved drug treatment.
In September 2020, we announced topline results from our
Phase 3 trial in PFIC, and we intend to complete regulatory
submissions in Europe and the United States no later than early
2021, in anticipation of potential regulatory approval, issuance of
a rare pediatric disease priority review voucher and commercial
launch in the second half of 2021, if approved. We are also
pursuing the development of odevixibat in biliary atresia and in
Alagille syndrome, or ALGS, each of which is a rare, life
threatening disease that affects the liver and for which there is
no approved pharmacologic treatment option. We initiated a pivotal
clinical trial of odevixibat in biliary atresia, the BOLD trial, in
the first half of 2020, and have enrolled the first patients in the
trial. We plan to initiate a pivotal trial in ALGS by the end of
2020. Our most advanced product candidate in addition to odevixibat
is elobixibat, which is approved in Japan for the treatment of
chronic constipation. In August 2020, we announced topline results
from our Phase 2 clinical trial as a treatment for
nonalcoholic fatty liver disease, or NAFLD, and nonalcoholic
steatohepatitis, or NASH, and based on the results of the trial, we
decided not to pursue further development of elobixibat in NAFLD or
NASH. We are exploring additional clinical development of our
product candidate A3384 based on an evaluation of its patent
coverage and our overall portfolio. We also have a preclinical
program in adult liver disease, and expect to complete
investigational new drug enabling studies in a lead preclinical
candidate this year.
Odevixibat—Our
Lead Product Candidate in PFIC. In September 2020, we announced topline
results from PEDFIC 1, our Phase 3 clinical trial for
odevixibat, given once per day as an oral capsule or sprinkled over
food, in patients ages 6 months to 18 years with PFIC
types 1 and 2, which was conducted at 45 global sites. PEDFIC
1 tested two doses of odevixibat, 40 µg/kg/day and 120 µg/kg/day,
along with placebo, over a treatment period of 24 weeks.
PEDFIC 1 met its two primary endpoints, demonstrating that
odevixibat reduced serum bile acid responses, or sBAs, (p=0.003)
and improved pruritus assessments (p=0.004) with a single digit
diarrhea rate. In the primary analysis, PEDFIC 1 met the U.S.
regulatory primary endpoint with the proportion of positive
pruritus assessments being 53.5% in the odevixibat arms compared to
28.7% in the placebo arm (p=0.004). As a secondary endpoint, 42.9%
of patients in the odevixibat arms had a clinically meaningful
improvement in the pruritus score, defined as a drop from baseline
of 1.0 point or more on the 0-4 point scale, at week 24 compared to
10.5% in the placebo arm (p=0.018). PEDFIC 1 also met the EU
regulatory primary endpoint with 33.3% of subjects in the
odevixibat arms experiencing either a 70% reduction in sBAs or
reaching a level of 70 mmol/L compared
to no patients in the placebo arm (p=0.003). As an EU regulatory
secondary endpoint, mean reduction of bile acids was 114.3 µmol/L
in the odevixibat arms compared to an increase of 13.1 µmol/L in
the placebo arm
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(p=0.002). Both doses
of odevixibat were statistically significant for each of the U.S.
and EU primary endpoints. Odevixibat was well tolerated, with an
overall adverse event incidence similar to placebo. There were no
drug-related serious adverse events, or SAEs, reported during the
study. Diarrhea/frequent bowel movements were the most common
treatment-related gastrointestinal adverse events, which occurred
in 9.5% of odevixibat treated patients vs. 5.0% of placebo
patients. In June 2018, the FDA granted a rare pediatric disease
designation to odevixibat for the treatment of PFIC, which affirms
our eligibility to apply for a rare pediatric disease priority
review voucher upon submission of a new drug application for
odevixibat. In September 2018, the FDA granted fast track
designation to odevixibat for the treatment of pruritus associated
with PFIC. In the first quarter of 2019, we revised our statistical
analysis methodology for PEDFIC 1, in line with guidance from the
U.S. Food and Drug Administration, or FDA, which resulted in an
improvement in the power of the study. We also submitted a protocol
amendment for PEDFIC 2, our long term, open label extension study,
which includes an additional cohort of PFIC patients who are not
eligible for PEDFIC 1. The first sites have been activated and
first patients enrolled in the expanded PEDFIC 2 cohort. In July
2020, we initiated an Expanded Access Program (EAP) for odevixibat
in the United States, Canada, Australia and Europe.
We hold global
rights to odevixibat unencumbered. Our current plan is to
commercialize odevixibat ourselves in the United States and Europe,
and we have begun the process of identifying potential partners for
other regions. There are currently no drugs approved for the
treatment of PFIC. First-line treatment for PFIC is typically
off-label ursodeoxycholic acid, or UDCA, which is approved in the
United States and elsewhere for the treatment of primary biliary
cholangitis, or PBC. However, many PFIC patients do not respond
well to UDCA, undergo partial external bile diversion, or PEBD,
surgery and often require liver transplantation. PEBD surgery is a
life-altering and undesirable procedure in which bile is drained
outside the body to a stoma bag that must be worn by the patient
24 hours a day.
Other
Indications Under Development for Odevixibat. We are also pursuing the development of
odevixibat in patients with biliary atresia, another rare,
life-threatening disease that affects the liver and for which there
is no approved pharmacologic treatment option. In December 2018,
the European Commission granted orphan designation to odevixibat
for the treatment of biliary atresia, and in January 2019, the FDA
granted orphan drug designation to odevixibat for the treatment of
biliary atresia. We initiated the BOLD clinical trial, a global
pivotal trial and the largest prospective intervention trial ever
conducted in biliary atresia, in the first half of 2020. The first
patients have been enrolled in the trial, and we plan for full site
activation in the first half of 2021, subject to any potential
impacts of COVID-19 on the enrollment. We believe biliary atresia
is one of the most common rare pediatric liver diseases, and is the
leading cause of liver transplants in children. Our double-blind,
placebo controlled pivotal trial in biliary atresia is designed to
enroll approximately 200 patients at 70 sites globally. Patients
will receive either placebo or high-dose (120µg/kg) odevixibat once
daily. The primary endpoint is survival with native liver after two
years of treatment.
Biliary atresia
is a partial or total blocking or absence of large bile ducts that
causes cholestasis and resulting accumulation of bile that damages
the liver. There are currently no drugs approved for the treatment
of biliary atresia. The current standard of care is a surgery known
as the Kasai procedure, or hepatoportoenterostomy, in which the
obstructed bile ducts are removed and a section of the small
intestine is connected to the liver directly. However, only an
estimated 25% of those initially undergoing the Kasai procedure
will survive to their twenties without need for liver
transplantation.
In addition, we
have agreed with the FDA and European Commission on a single
pivotal study design for odevixibat in ALGS, and we plan to
initiate the trial by the end of 2020. We expect topline
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data to be available
before the announcement of the topline results from the BOLD
clinical trial. ALGS is a genetic condition associated with liver,
heart, eye, kidney and skeletal abnormalities. In particular, ALGS
patients have fewer than normal bile ducts inside the liver, which
leads to cholestasis and the accumulation of bile and causes
scarring in the liver. There are currently no drugs approved for
the treatment of ALGS. Current treatment for ALGS is generally in
line with current treatments for PFIC as described above. In August
2012, the European Commission granted orphan designation to
odevixibat for the treatment of ALGS. In October 2018, the FDA
granted orphan drug designation to odevixibat for the treatment of
ALGS.
We continue to
evaluate potential clinical development in other indications,
including primary sclerosing cholangitis, which refers to swelling
(inflammation), scarring, and destruction of bile ducts inside and
outside of the liver. The first symptoms are typically fatigue,
itching and jaundice, and many patients with sclerosing cholangitis
also suffer from inflammatory bowel disease. There are currently no
drugs approved for the treatment of sclerosing cholangitis.
First-line treatment is typically off-label UDCA, although UDCA has
not been established to be safe and effective in patients with
sclerosing cholangitis in well controlled clinical
trials.
Our Pipeline
The following
table summarizes our most advanced product candidates and
programs:

Our Strategy
Our goal is to
be a leader in the development and commercialization of novel
therapeutics for orphan pediatric cholestatic liver diseases and
disorders where there is high unmet medical need, while also
leveraging our expertise in bile acid modulation to treat other
liver and GI diseases and disorders. To achieve our goal, we intend
to pursue the following strategies.
- §
- Rapidly develop
odevixibat to regulatory approval as a treatment for patients with
PFIC. We recently
announced topline results from our Phase 3 clinical trial in
patients with PFIC, which we refer to as PEDFIC 1. It is our
objective that PEDFIC 1, together with available data from
PEDFIC 2, our long-term, open label extension study, forms the
primary support for applications for marketing approval of
odevixibat in both the United States and Europe.
- §
- Maximize the
benefit and commercial potential of odevixibat by expanding
development to additional orphan pediatric cholestatic
indications. Although we have
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chosen PFIC as our
lead program for odevixibat, we also believe odevixibat can benefit
children suffering from other cholestatic diseases and disorders.
We initiated a pivotal clinical trial with odevixibat for the
treatment of biliary atresia, the BOLD trial, in the first half of
2020, and the first patients have been enrolled in the trial. We
estimate biliary atresia impacts an aggregate of 15,000 to 20,000
patients in the United States and Europe, and is the cause of over
50% of liver transplants in children. We also plan to initiate a
pivotal trial for odevixibat as a treatment for ALGS by the end of
2020.
- §
- Develop the
capability to commercialize odevixibat to treat orphan pediatric
liver diseases, if approved, through a targeted sales force in the
United States and Europe and collaborate selectively to
commercialize odevixibat outside of these
regions. If we
receive marketing approval in the United States or Europe for
odevixibat as a treatment for patients with PFIC or any other
pediatric cholestatic liver disease or disorder, we plan to build
the capabilities to effectively commercialize odevixibat in the
approved indication(s) in the applicable region. We believe that
the required commercial organization would be modest in size and
targeted to the relatively small number of specialists in the
United States and Europe who treat children with cholestatic liver
disease. If we receive marketing approval outside of the United
States and Europe for odevixibat as a treatment for patients with
PFIC or any other pediatric cholestatic liver disease or disorder,
we plan to selectively utilize collaboration, distribution and
other marketing arrangements with third parties to commercialize
odevixibat in the approved indication(s) in the regions or markets
where we receive approval.
- §
- Collaborate
selectively to develop and commercialize product candidates
targeting nonorphan indications, potentially including A3384 or any
future product candidate to treat adult liver
diseases. We
intend to selectively seek alliances and collaborations to assist
us in furthering the development or commercialization of product
candidates targeting large primary care markets that must be served
by large sales and marketing organizations. These product
candidates may include A3384 and any potential future product
candidate that arises from our preclinical program in adult liver
diseases.
Risks Relating to Our Business
We are a
biopharmaceutical company, and our business and ability to execute
our business strategy are subject to a number of significant risks
of which you should be aware before you decide to buy shares of our
common stock. Among these important risks are the
following:
- §
- We have incurred
significant losses since our inception. We expect to continue to
incur losses and may never generate profits from operations or
maintain profitability.
- §
- Our limited operating
history may make it difficult for you to evaluate the success of
our business to date and to assess our future
viability.
- §
- We will need
substantial additional funding. If we are unable to raise capital
when needed, we could be forced to delay, reduce or eliminate our
product development programs or commercialization
efforts.
- §
- We depend heavily on
the success of our lead product candidate, odevixibat, which we are
developing initially for the treatment of patients with PFIC and
potentially also for other pediatric cholestatic liver diseases and
disorders. If we are unable to commercialize odevixibat or
experience significant delays in doing so, our business will be
materially harmed.
- §
- If clinical trials of
odevixibat or any of our other product candidates fail to
demonstrate safety and efficacy to the satisfaction of the U.S.
Food and Drug Administration, or the FDA, or the European Medicines
Agency, or the EMA, or do not otherwise produce favorable results
satisfactory to the FDA or EMA, we may incur additional costs
or
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experience delays in
completing, or ultimately be unable to complete, the development
and commercialization of the applicable product
candidate.
- §
- Favorable results
seen to date in clinical trials of odevixibat, including our
Phase 3 trial of odevixibat in patients with PFIC, may not be
predictive of favorable results in our ongoing BOLD clinical trial
of odevixibat in biliary atresia or our planned pivotal trial of
odevixibat in ALGS.
- §
- The clinical trial
designs, durations, endpoints and outcomes that will be required to
obtain marketing approval of odevixibat to treat PFIC patients are
uncertain and, in any case, may vary among the FDA, EMA and other
regulatory authorities outside of the United States and Europe.
Based on feedback that we have received from the FDA and the EMA,
we expect both regulatory authorities to place a greater emphasis
on the totality of the data from our Phase 3 clinical trial,
including secondary endpoints, than may generally be expected. As a
result, there is risk that, even though the primary endpoint of our
Phase 3 clinical trial of odevixibat for FDA evaluation
purposes or for EMA evaluation purposes was met with statistical
significance, the applicable regulatory authority may not find the
overall results of our Phase 3 trial to be sufficient to
support marketing approval of odevixibat to treat PFIC, a symptom
of PFIC such as pruritus or any other indication, and we may never
receive marketing approval.
- §
- The design of our
Phase 3 clinical trial of odevixibat in patients with PFIC
does not conform precisely in all respects to the recommendations
or preferences expressed by either the FDA or EMA.
- §
- If we experience
delays or difficulties in the enrollment of patients in our pivotal
clinical trials of odevixibat in patients with biliary atresia and
ALGS, our receipt of marketing approval for odevixibat in those
indications could be delayed or prevented.
- §
- If the commercial
opportunity in PFIC is smaller than we anticipate, or if odevixibat
receives approval to treat only a specific subpopulation of
patients with PFIC or only a specific symptom of PFIC such as
pruritus, our future revenue from odevixibat may be adversely
affected and our business may suffer.
- §
- If we are unable to
establish sales and marketing capabilities or enter into agreements
with third parties to market and sell odevixibat or any of our
other current or potential future product candidates, we may not be
successful in commercializing the applicable product candidate if
it receives marketing approval.
- §
- We face substantial
competition, which may result in others discovering, developing or
commercializing products to treat our target indications or markets
before or more successfully than we do.
- §
- We rely on third
parties to conduct our clinical trials and those third parties may
not perform satisfactorily, including failing to meet deadlines for
the completion of such clinical trials.
- §
- Use of third parties
to manufacture our product candidates may increase the risk that we
will not have sufficient quantities of our product candidates or
products or such quantities at an acceptable cost, which could
delay, prevent or impair our development or commercialization
efforts.
- §
- If we are unable to
obtain and maintain patent protection for our technology and
products, or if the scope of the patent protection is not
sufficiently broad, our competitors could develop and commercialize
technology and products similar or identical to ours, and our
ability to successfully commercialize our technology and products
may be adversely affected.
- §
- Third parties may
initiate legal proceedings alleging that we are infringing their
intellectual property rights, the outcome of which would be
uncertain and could have a material adverse effect on the success
of our business.
- §
- Even if we complete
the necessary clinical trials, the marketing approval process is
expensive, time consuming and uncertain and may prevent us from
obtaining approvals for
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the commercialization
of some or all of our product candidates. If we are not able to
obtain, or if there are delays in obtaining, required marketing
approvals, we will not be able to commercialize our product
candidates, and our ability to generate revenue will be materially
impaired.
- §
- The outbreak of the
novel strain of coronavirus, SARS-CoV-2, which causes COVID-19,
could adversely impact our business, including our preclinical
studies and clinical trials and the commercialization of any
approved product.
- §
- The terms of our loan
and security agreement with Hercules Capital, Inc. require us
to meet certain operating covenants and place restrictions on our
operating and financial flexibility. If we raise additional capital
through debt financing, the terms of any new debt could further
restrict our ability to operate our business.
For additional
information about the risks we face, please see the information
contained in or incorporated by reference under "Risk Factors" in
this prospectus supplement and the accompanying
prospectus.
Corporate Information
Prior to
November 3, 2016, we were a specialty biopharmaceutical
company known as Biodel Inc., which was originally
incorporated in the State of Delaware in December 2003 under the
name "Global Positioning Group, Ltd." and subsequently changed
its name to "Biodel Inc." Albireo Limited was formed in
connection with a spinout transaction from AstraZeneca AB in 2008.
On November 3, 2016, we completed a share exchange transaction
in which each holder of Albireo Limited shares or notes convertible
into Albireo Limited shares sold their shares of Albireo Limited
for newly issued shares of our common stock. As a result, Albireo
Limited became a wholly owned subsidiary of Biodel, Biodel's
corporate name was changed to Albireo Pharma, Inc., the
business of Albireo Limited became our business and we became a
biopharmaceutical company focused on the development and
commercialization of novel bile acid modulators to treat orphan
pediatric liver diseases and gastrointestinal disorders.
Our corporate
headquarters are located at 10 Post Office Square, Suite 1000,
Boston, Massachusetts 02109 and our telephone number is
(857) 254-5555. We also have an office in Gothenburg, Sweden.
We maintain a website at www.albireopharma.com, to which we
regularly post copies of our press releases as well as additional
information about us. The information contained on, or that can be
accessed through, our website is not a part of this prospectus
supplement or the accompanying prospectus. We have included our
website address in this prospectus supplement solely as an inactive
textual reference.
Our Annual
Reports on Form 10-K, Quarterly Reports on Form 10-Q,
Current Reports on Form 8-K and all amendments to those
reports filed or furnished pursuant to Section 13(a) or 15(d)
of the Securities Exchange Act of 1934, as amended, or the Exchange
Act, are available free of charge through the investor relations
page of our internet website as soon as reasonably practicable
after we electronically file such material with, or furnish it to,
the SEC.
All brand names
or trademarks appearing in this prospectus supplement and the
accompanying prospectus are the property of their respective
holders. Use or display by us of other parties' trademarks, trade
dress, or products in this prospectus supplement and the
accompanying prospectus is not intended to, and does not, imply a
relationship with, or endorsements or sponsorship of, us by the
trademark or trade dress owners.
S-6
Table of
Contents
THE OFFERING
|
|
|
Common stock offered by us pursuant to this
prospectus supplement
|
|
4,000,000
shares. |
Common stock estimated to be outstanding immediately
after this offering
|
|
18,989,021 shares (or 19,589,021 shares if the
underwriters exercise their option to purchase additional shares of
common stock in full).
|
Option to purchase additional shares
|
|
We have granted the underwriters an option for a
period of up to 30 days to purchase up to 600,000 additional
shares of common stock at the offering price.
|
Offering price
|
|
$40.00 per share of common stock.
|
Use of Proceeds
|
|
We estimate that the net proceeds from this offering
will be approximately $150.1 million, or approximately
$172.6 million if the underwriters exercise their option to
purchase additional shares in full, after deducting the
underwriting discounts and commissions and estimated offering
expenses payable by us.
|
|
|
We intend to use substantially all of the net
proceeds from this offering: (i) to further our
commercialization and other preparations for a potential future
launch of odevixibat in the United States and Europe; (ii) to
advance the pivotal trial of odevixibat in biliary atresia and the
planned pivotal trial of odevixibat in ALGS; (iii) to advance
the development of our preclinical assets; and (iv) for
general and administrative expenses, capital expenditures, working
capital and other general corporate purposes. See "Use of Proceeds"
on page S-15 of this prospectus supplement for a more complete
description of the intended use of proceeds from this
offering.
|
Risk Factors
|
|
An investment in our common stock involves a high
degree of risk. See the information contained in or incorporated by
reference under "Risk Factors" on page S-9 of this prospectus
supplement, as well as the other information included in or
incorporated by reference in this prospectus supplement and the
accompanying prospectus.
|
Nasdaq Capital Market Symbol
|
|
Our common stock is listed on The Nasdaq Capital
Market under the symbol "ALBO."
|
S-7
Table of
Contents
The number of
shares of our common stock to be outstanding after this offering is
based on an aggregate of 14,989,021 shares of our common stock
outstanding as of June 30, 2020 and excludes:
- §
- 2,384,178 shares of
our common stock issuable upon the exercise of stock options
outstanding as of June 30, 2020, at a weighted average
exercise price of $23.11 per share, of which 949,374 shares were
vested as of such date;
- §
- 50,441 shares of our
common stock issuable upon the vesting of restricted stock units
outstanding as of June 30, 2020;
- §
- 5,311 shares of our
common stock issuable upon the exercise of warrants outstanding as
of June 30, 2020, at an exercise price of $18.83 per
share;
- §
- 1,994,692 shares of
common stock reserved for future issuance under our 2018 Equity
Incentive Plan, as amended, or the 2018 Plan, as of June 30,
2020; and
- §
- 283,727 shares of
common stock reserved for future issuance under our 2018 Employee
Stock Purchase Plan, or the 2018 ESPP, as of June 30,
2020.
Except as
otherwise indicated, all information in this prospectus supplement
assumes no exercise of outstanding stock options or warrants, no
vesting of outstanding restricted stock units, and no new stock
options or other types of awards are issued under our equity
incentive plans, as described above, and no exercise by the
underwriters of their option to purchase additional shares of our
common stock.
S-8
Table of
Contents
RISK FACTORS
You
should consider carefully the risks described below and discussed
in the section titled "Risk Factors" contained in our Annual Report
on Form 10-K for the year ended December 31, 2019, as
updated by our subsequent filings under the Exchange Act, each of
which is incorporated by reference in this prospectus supplement
and the accompanying prospectus in their entirety, together with
other information in this prospectus supplement and the
accompanying prospectus, and the information and documents
incorporated by reference in this prospectus supplement and the
accompanying prospectus, and any free writing prospectus that we
have authorized for use in connection with this offering, before
you make a decision to invest in our shares of common stock. If any
of the following events actually occur, our business, financial
condition, results of operations or cash flow could be harmed. This
could cause the trading price of our common stock to decline and
you may lose all or part of your investment. The risks below and
incorporated by reference in this prospectus supplement and the
accompanying prospectus are not the only ones we face. Additional
risks not currently known to us or that we currently deem
immaterial may also affect our business operations. Please also
read carefully the section below titled "Special Note Regarding
Forward-Looking Statements."
Risks Related to Our Business
Use of third parties to manufacture our product candidates may
increase the risk that we will not have sufficient quantities of
our product candidates or products or such quantities at an
acceptable cost, which could delay, prevent or impair our
development or commercialization efforts.
We do not own
or operate manufacturing facilities for the production of clinical
or commercial supplies of our product candidates. We have limited
personnel with experience in drug manufacturing and lack the
resources and the capabilities to manufacture any of our product
candidates on a clinical or commercial scale. We currently rely on
third parties for supply of the active pharmaceutical ingredients,
or API, in our product candidates. Our strategy is to outsource all
manufacturing of our product candidates and any approved products
to third parties.
We do not
currently have any agreements with third-party manufacturers for
the long-term clinical or commercial supply of any of our product
candidates. We currently engage a single third-party manufacturer
to provide API for odevixibat and elobixibat. We also currently
engage single third-party manufacturers to provide fill and finish
services for the final drug product formulation of each of our
product candidates in development. We may in the future be unable
to enter into agreements for commercial supply with third-party
manufacturers on acceptable terms, or at all. In addition, while we
believe that there are alternative sources available to manufacture
our product candidates, in the event that we seek such alternative
sources, we may not be able to enter into replacement arrangements
without delays or additional expenditures. We cannot estimate these
delays or costs with certainty but, if they were to occur, they
could cause a delay in our development and commercialization
efforts. If our third party manufacturing agreements are terminated
or if the sources of supply from such arrangements are inadequate
and we must seek supply agreements from alternative sources, we may
be unable to enter into such agreements or do so on commercially
reasonable terms, which could delay a product launch or subject our
commercialization efforts to significant supply risk.
Even if we are
able to establish and maintain arrangements with third-party
manufacturers, reliance on third-party manufacturers entails
additional risks, including:
- §
- reliance on the third
party for regulatory compliance and quality assurance;
S-9
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- §
- the possible breach
of the manufacturing agreement by the third party;
- §
- the possible
misappropriation of our proprietary information, including our
trade secrets and know-how; and
- §
- the possible
termination or nonrenewal of the agreement by the third party at a
time that is costly or inconvenient for us.
Manufacturers
of our product candidates are obliged to operate in accordance with
FDA-mandated current good manufacturing practices, or cGMPs. The
manufacture of pharmaceutical products in compliance with cGMPs
requires significant expertise and capital investment, including
the development of advanced manufacturing techniques and process
controls. Manufacturers of pharmaceutical products often encounter
difficulties in production, including difficulties with volume
production, production costs and yields, laboratory testing,
quality control, including stability of the product or product
candidate, or quality assurance testing, or suffer shortages of
qualified personnel, as well as compliance with strictly enforced
cGMP requirements, other federal and state regulatory requirements
and foreign regulations, any of which could result in our inability
to manufacture sufficient quantities to meet clinical timelines for
a particular product candidate, to obtain marketing approval for
the product candidate or to commercialize the product candidate. If
our manufacturers were to encounter any of these difficulties or
otherwise fail to comply with their obligations to us or under
applicable regulations, our ability to provide product for
commercial sale or product candidates in our clinical trials would
be jeopardized.
In addition,
the facilities used by our contract manufacturers or other third
party manufacturers to manufacture our product candidates must be
approved by the FDA pursuant to inspections conducted following our
request for regulatory approval for our product candidates from the
FDA. These requirements include, among other things, quality
control, quality assurance and the maintenance of records and
documentation. Manufacturers of our product candidates may be
unable to comply with these cGMP requirements and with other FDA,
state and foreign regulatory requirements. The FDA or similar
foreign regulatory agencies may also implement new standards at any
time, or change their interpretation and enforcement of existing
standards for manufacture, packaging or testing of products. We
have little control over our manufacturers' compliance with these
regulations and standards. A failure of any of our current or
future contract manufacturers to establish and follow cGMPs and to
document their adherence to such practices may lead to significant
delays in clinical trials or in obtaining regulatory approval of
product candidates or the ultimate launch of products, if approved,
into the market. Failure by our current or future third-party
manufacturers or us to comply with applicable regulations could
result in sanctions being imposed on us, including fines,
injunctions, civil penalties, failure of the government to grant
pre-market approval of drugs, delays, suspension or withdrawal of
approvals, seizures or recalls of products, operating restrictions,
and criminal prosecutions. If the safety of any product supplied is
compromised due to our manufacturers' failure to adhere to
applicable laws or for other reasons, we may not be able to obtain
regulatory approval for or successfully commercialize our products
and we may be held liable for any injuries sustained as a result.
Any of these factors could cause a delay of clinical studies,
regulatory submissions, approvals or commercialization of our
product candidates or approved products, entail higher costs or
impair our reputation.
Our product
candidates and any products that we may develop may compete with
other product candidates and products for access to manufacturing
facilities. There are a limited number of manufacturers that
operate under cGMP regulations and that might be capable of
manufacturing for us.
If the third
parties that we engage to manufacture product for our preclinical
tests and clinical trials cease to continue to do so for any
reason, we likely would experience delays in advancing
S-10
Table of
Contents
these clinical trials
while we identify and qualify replacement suppliers and we may be
unable to obtain replacement supplies on terms that are favorable
to us. In addition, if we are not able to obtain adequate supplies
of our product candidates or the drug substances used to
manufacture them, it will be more difficult for us to develop our
product candidates and compete effectively. Furthermore, any delay
or interruption in the supply of commercial quantities of approved
product could have a material adverse impact on our revenue from
product sales and any delay or interruption in the supply of
clinical trial materials could delay the completion of our clinical
trials, increase the costs associated with maintaining our clinical
development programs and, depending upon the period of delay,
require us to commence new clinical trials or redo work that has
already been done, in either case at significant additional expense
to us, or to terminate the clinical trials completely.
Our current and
anticipated future dependence upon others for the manufacture of
our product candidates may adversely affect our future profit
margins and our ability to develop product candidates and
commercialize any products that receive marketing approval on a
timely and competitive basis.
Risks Related to this Offering
If you purchase shares of common stock in this offering, you will
suffer immediate dilution of your investment.
The public
offering price of our common stock is substantially higher than the
net tangible book value per share of our common stock. Therefore,
if you purchase shares of our common stock in this offering, you
will pay a price per share that substantially exceeds our net
tangible book value per share after giving effect to this offering.
If you purchase common stock in this offering, based on the public
offering price of $40.00 per share and our net tangible book value
on June 30, 2020, you will incur an immediate and substantial
dilution in net tangible book value of $28.31 per share. For a
further description of the dilution that you will experience
immediately after this offering, see "Dilution." In addition, in
the past, we have granted options and warrants to acquire common
stock at prices significantly below the offering price and have
granted restricted stock units. To the extent these outstanding
options or warrants are exercised or these restricted stock units
vest, you will incur additional dilution.
Our management will have broad discretion over the use of the net
proceeds from this offering, and you may not agree with how we use
the proceeds and the proceeds may not be invested
successfully.
Our management
will have broad discretion as to the use of the net proceeds from
this offering and could use them for purposes other than those
contemplated at the time of this offering. Accordingly, you are
relying on the judgment of our management with regard to the use of
these net proceeds, and you will not have the opportunity, as part
of your investment decision, to assess whether the proceeds will be
used appropriately. It is possible that the proceeds will be
invested in a way that does not yield a favorable, or any,
return.
Because we do not anticipate paying any cash dividends on our
capital stock in the foreseeable future, capital appreciation, if
any, will be your sole source of gain.
Except for a
single dividend paid by Albireo Limited in 2012, we have never paid
or declared any cash dividends on our capital stock. We currently
intend to retain earnings, if any, to finance the growth and
development of our business and we do not anticipate paying any
cash dividends in the foreseeable future. As a result, only
appreciation of the price of our common stock will provide a return
to our stockholders.
S-11
Table of
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Sales of a significant number of shares of our common stock in the
public markets, or the perception that such sales could occur,
could depress the market price of our common
stock.
Sales of a
substantial number of shares of our common stock in the public
markets could depress the market price of our common stock and
impair our ability to raise capital through the sale of additional
equity securities. We, our directors and our executive officers
have agreed not to sell, dispose of or hedge any common stock or
securities convertible into or exchangeable for shares of common
stock during the period from the date of this prospectus supplement
continuing through and including the date 90 days after the
date of this prospectus supplement, subject to certain exceptions.
The underwriters may, in their discretion, release the restrictions
on any such shares at any time without notice. We cannot predict
the effect that future sales of our common stock would have on the
market price of our common stock.
S-12
Table of
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SPECIAL NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This prospectus
supplement, the accompanying prospectus and the documents we have
filed with the SEC that are incorporated by reference contain
"forward-looking statements" within the meaning of Section 27A
of the Securities Act of 1933, as amended, or the Securities Act,
and Section 21E of the Exchange Act, that relate to future
events or to our future operations or financial performance. Any
forward-looking statement involves known and unknown risks,
uncertainties and other factors that may cause our actual results,
levels of activity, performance or achievements to differ
materially from any future results, levels of activity, performance
or achievements expressed or implied by such forward-looking
statement. Forward-looking statements include statements, other
than statements of historical fact, about, among other
things:
- §
- the progress, number,
scope, cost, duration or results of our development activities,
nonclinical studies and clinical trials of odevixibat (formerly
known as A4250), A3384 or any of our other product candidates or
programs, such as the target indication(s) for development or
approval, the size, design, population, conduct, cost, objective or
endpoints of any clinical trial, or the timing for initiation or
completion of or availability of results from any clinical trial
(including BOLD, our pivotal clinical trial of odevixibat in
patients with biliary atresia, or our planned pivotal trial of
odevixibat in ALGS) for submission or approval of any regulatory
filing, access to the Expanded Access Program (EAP) for odevixibat,
or meetings with regulatory authorities;
- §
- the potential
benefits that may be derived from any of our product
candidates;
- §
- the timing of and our
ability to obtain and maintain regulatory approval of our existing
product candidates, any product candidates that we may develop, and
any related restrictions, limitations, or warnings in the label of
any approved product candidates;
- §
- any payment that EA
Pharma Co., Ltd., or EA Pharma, may make to us or any
other action or decision that EA Pharma may make concerning
elobixibat or our business relationship;
- §
- the potential impacts
of the COVID-19 pandemic on our business operations or financial
condition;
- §
- our future
operations, financial position, revenues, costs, expenses, uses of
cash, capital requirements, our need for additional financing or
the period for which our existing cash resources will be sufficient
to meet our operating requirements;
- §
- our use of proceeds
from this offering; and
- §
- our strategies,
prospects, plans, expectations, forecasts or
objectives.
Words such as,
but not limited to, "believe," "expect," "anticipate," "estimate,"
"forecast," "intend," "may," "plan," "potential," "predict,"
"project," "targets," "likely," "will," "would," "could," "should,"
"continue," "scheduled" and similar expressions or phrases, or the
negative of those expressions or phrases, are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Although we believe
that we have a reasonable basis for each forward-looking statement
contained in this prospectus supplement, we caution you that these
statements are based on our estimates or projections of the future
that are subject to known and unknown risks and uncertainties and
other important factors that may cause our actual results, level of
activity, performance, experience or achievements expressed or
implied by any forward-looking statement to differ. These risks,
uncertainties and other factors are described in greater detail
under the caption "Risk Factors" beginning on page S-9 of this
prospectus supplement, on page 5 of the accompanying
prospectus or in our Annual Report on Form 10-K for the year
ended December 31, 2019 or other documents incorporated by
reference into this prospectus supplement and the accompanying
prospectus. Also, these forward-looking statements represent our
estimates and assumptions only as of the date of the document
containing the
S-13
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applicable statement.
As a result of the risks and uncertainties, the results or events
indicated by the forward-looking statements may not occur. We
caution you not to place undue reliance on any forward-looking
statement.
You should read
this prospectus supplement, the accompanying prospectus and the
documents we have filed with the SEC that are incorporated by
reference completely and with the understanding that our actual
future results may be materially different from what we expect. We
qualify all of the forward-looking statements in the foregoing
documents by these cautionary statements. Unless required by law,
we undertake no obligation to update or revise any forward-looking
statements to reflect new information or future events or
developments. Thus, you should not assume that our silence over
time means that actual events are bearing out as expressed or
implied in such forward-looking statements.
S-14
Table of
Contents
USE OF PROCEEDS
We estimate
that the net proceeds we will receive from the sale of 4,000,000
shares of our common stock in this offering will be approximately
$150.1 million, or approximately $172.6 million if the
underwriters exercise their option to purchase additional shares of
our common stock in full, after deducting underwriting discounts
and commissions and estimated offering expenses payable by
us.
We currently
estimate that we will use the net proceeds from this
offering:
- §
- to further our
commercialization and other preparations for a potential future
launch of odevixibat in the United States and Europe;
- §
- to advance the
pivotal trial of odevixibat in biliary atresia and the planned
pivotal trial of odevixibat in ALGS;
- §
- to advance the
development of our preclinical assets; and
- §
- for general and
administrative expenses, capital expenditures, working capital and
other general corporate purposes.
Our expected
use of the net proceeds from this offering represents our current
intentions based upon our present plans and business conditions.
The amounts and timing of our actual use of net proceeds will vary
depending on numerous factors, including the relative success and
cost of our preclinical and clinical development programs, whether
we are able to enter into future collaborations, and any unforeseen
delays or cash needs. As a result, our management will have broad
discretion in the application of the net proceeds, and investors
will be relying on our judgment regarding the application of the
net proceeds of this offering. In addition, we might decide to
postpone or not pursue these planned trials and activities or other
development activities if the net proceeds from this offering and
the other sources of cash are less than, or do not last as long as,
expected.
Pending their
use, we plan to invest the net proceeds from this offering in
short- and intermediate-term, interest-bearing obligations,
investment-grade instruments, certificates of deposit or direct or
guaranteed obligations of the U.S. government.
S-15
Table of
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DIVIDEND POLICY
Except for a
single dividend paid by Albireo Limited in 2012, we have never paid
or declared any cash dividends on our common stock. We currently
intend to retain earnings, if any, to finance the growth and
development of our business and we do not anticipate paying any
cash dividends in the foreseeable future. In addition, the terms of
our loan and security agreement with Hercules Capital, Inc.
prohibit us from paying cash dividends. Any future determination to
pay cash dividends will be at the discretion of our Board of
Directors and will depend on our financial condition, operating
results, restrictions in the agreements governing any indebtedness
we may enter into, capital requirements and such other factors as
our Board of Directors deems relevant.
S-16
Table of
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CAPITALIZATION
The following
table sets forth our cash and cash equivalents and our
capitalization as of June 30, 2020:
- §
- on an actual basis;
and
- §
- on an as adjusted
basis to give effect to the issuance and sale by us of 4,000,000
shares of our common stock in this offering at the public offering
price of $40.00 per share, after deducting underwriting discounts
and commissions and estimated offering expenses payable by
us.
This table
should be read together with our consolidated financial statements
and related notes and the other financial information included or
incorporated by reference in this prospectus supplement and the
accompanying prospectus.
|
|
|
|
|
|
|
|
|
|
As of June 30,
2020 |
|
|
|
Actual |
|
As Adjusted |
|
|
|
(In thousands,
except share and per share data)
|
|
Cash and cash equivalents
|
|
$ |
152,020 |
|
$ |
302,070 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term debt
|
|
|
9,400 |
|
|
9,400 |
|
Stockholders' equity:
|
|
|
|
|
|
|
|
Common stock, $0.01 par value per share; 30,000,000
authorized; 14,989,021 issued and outstanding, actual; 18,989,021
shares issued and outstanding, as adjusted
|
|
|
149 |
|
|
189 |
|
Additional paid-in capital
|
|
|
294,075 |
|
|
444,085 |
|
Accumulated other comprehensive income
|
|
|
6,174 |
|
|
6,174 |
|
Accumulated deficit
|
|
|
(211,278 |
) |
|
(211,278 |
) |
|
|
|
|
|
|
|
|
Total stockholders' equity
|
|
|
89,120 |
|
|
239,170 |
|
|
|
|
|
|
|
|
|
Total capitalization
|
|
$ |
98,520 |
|
$ |
248,570 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The number of
shares of our common stock to be outstanding after this offering is
based on an aggregate of 14,989,021 shares of our common stock
outstanding as of June 30, 2020. The table above does not
include:
- §
- 2,384,178 shares of
our common stock issuable upon the exercise of stock options
outstanding as of June 30, 2020, at a weighted average
exercise price of $23.11 per share, of which 949,374 shares were
vested as of such date;
- §
- 50,441 shares of our
common stock issuable upon the vesting of restricted stock units
outstanding as of June 30, 2020;
- §
- 5,311 shares of our
common stock issuable upon the exercise of warrants outstanding as
of June 30, 2020, at an exercise price of $18.83 per
share;
- §
- 1,994,692 shares of
common stock reserved for future issuance under the 2018 Plan as of
June 30, 2020; and
- §
- 283,727 shares of
common stock reserved for future issuance under the 2018 ESPP as of
June 30, 2020.
S-17
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DILUTION
If you invest
in our common stock, your ownership interest will be diluted
immediately to the extent of the difference between the offering
price per share of our common stock and the as adjusted net
tangible book value per share of our common stock after this
offering.
As of
June 30, 2020, our historical net tangible book value was
$71.9 million, or $4.79 per share of common stock. Historical
net tangible book value per share represents the amount of our
total tangible assets less total liabilities, divided by
14,989,021, the number of shares of common stock outstanding as of
June 30, 2020.
After giving
effect to the sale of 4,000,000 shares of our common stock in this
offering at the public offering price of $40.00 per share, and
after deducting underwriting discounts and commissions and
estimated offering expenses payable by us, our net tangible book
value as of June 30, 2020 would have been $221.9 million
or $11.69 per share of common stock. This amount represents an
immediate increase in net tangible book value of $6.90 per share of
common stock to our existing stockholders and an immediate dilution
in net tangible book value of $28.31 per share of common stock to
new investors purchasing our shares of common stock in this
offering. We determine dilution by subtracting the net tangible
book value per share after the offering from the amount of cash
that a new investor paid for a share of common stock.
The following
table illustrates this dilution on a per share basis to new
investors:
|
|
|
|
|
|
|
|
Public offering price per share
|
|
|
|
|
$ |
40.00 |
|
Historical net tangible book value per share as of
June 30, 2020
|
|
$ |
4.79 |
|
|
|
|
Increase in net tangible book value per share
attributable to this offering
|
|
|
6.90 |
|
|
|
|
|
|
|
|
|
|
|
|
As adjusted net tangible book value per share after
giving effect to this offering
|
|
|
|
|
|
11.69 |
|
|
|
|
|
|
|
|
|
Dilution in as adjusted net tangible book value per
share to new investors purchasing shares in this
offering
|
|
|
|
|
$ |
28.31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
If the
underwriters exercise their option to purchase 600,000 additional
shares of our common stock in full at the public offering price of
$40.00 per share, the net tangible book value per share after
giving effect to the offering would be $12.48 per share. This
represents an immediate increase in as adjusted net tangible book
value of $7.69 per share to existing stockholders and an immediate
dilution in net tangible book value of $27.52 per share to new
investors purchasing shares of our common stock in this
offering.
The above
discussion and table are based on 14,989,021 shares of common stock
outstanding as of June 30, 2020, and exclude:
- §
- 2,384,178 shares of
our common stock issuable upon the exercise of stock options
outstanding as of June 30, 2020, at a weighted average
exercise price of $23.11 per share, of which 949,374 shares were
vested as of such date;
- §
- 50,441 shares of our
common stock issuable upon the vesting of restricted stock units
outstanding as of June 30, 2020;
- §
- 5,311 shares of our
common stock issuable upon the exercise of warrants outstanding as
of June 30, 2020, at an exercise price of $18.83 per
share;
- §
- 1,994,692 shares of
common stock reserved for future issuance under the 2018 Plan as of
June 30, 2020; and
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- §
- 283,727 shares of
common stock reserved for future issuance under the 2018 ESPP as of
June 30, 2020.
To the extent
that outstanding options or warrants are exercised, restricted
stock units vest or new stock options or other types of awards are
issued under our equity incentive plans, you will experience
further dilution. In addition, we may choose to raise additional
capital due to market conditions or strategic considerations even
if we believe we have sufficient funds for our current or future
operating plans. To the extent that additional capital is raised
through the sale of equity or convertible debt securities, the
issuance of these securities may result in further dilution to our
stockholders.
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MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO
NON-U.S. HOLDERS
The following
summary describes the material U.S. federal income tax consequences
of the acquisition, ownership and disposition of our common stock
acquired in this offering by Non-U.S. Holders (as defined below).
This discussion does not address all aspects of U.S. federal income
taxes and does not deal with foreign, state and local consequences
or the alternative minimum tax or federal Medicare contribution tax
consequences that may be relevant to Non-U.S. Holders in light of
their particular circumstances, nor does it address U.S. federal
tax consequences other than income taxes (not addressed, for
instance, are gift and estate taxes). Special rules different from
those described below may apply to certain Non-U.S. Holders that
are subject to special treatment under the Internal Revenue Code of
1986, or the Code, such as financial institutions, insurance
companies, tax-exempt organizations, tax-qualified retirement
plans, broker-dealers and traders in securities, commodities or
currencies, U.S. expatriates and certain former citizens and other
long-term residents of the United States, "controlled foreign
corporations," "passive foreign investment companies," corporations
that accumulate earnings to avoid U.S. federal income tax, persons
that hold our common stock as part of a "straddle," "hedge,"
"conversion transaction," "synthetic security" or integrated
investment or other risk reduction strategy, persons that are
deemed to sell our common stock under the constructive sale
provisions of the Code, persons who hold or receive our common
stock pursuant to the exercise of options or otherwise as
compensation, persons that own or are deemed to own more than 5% of
our common stock (except as specifically set forth below),
partnerships and other pass-through entities and arrangements
treated as pass-through entities, and investors in such
pass-through entities. Such Non-U.S. Holders are urged to consult
their own tax advisors to determine the U.S. federal, state, local
and other tax consequences that may be relevant to them.
Furthermore, the discussion below is based upon the provisions of
the Code, and Treasury regulations, rulings and judicial decisions
thereunder as of the date hereof, and such authorities may be
repealed, revoked or modified, perhaps retroactively, so as to
result in U.S. federal income tax consequences different from those
discussed below. We have not requested a ruling from the U.S.
Internal Revenue Service, or IRS, with respect to the statements
made and the conclusions reached in the following summary, and
there can be no assurance that the IRS will agree with such
statements and conclusions. This discussion assumes that the
Non-U.S. Holder holds our common stock as a "capital asset" within
the meaning of Section 1221 of the Code (generally, property
held for investment).
In addition,
this discussion does not address the tax treatment of partnerships
(or entities or arrangements that are treated as partnerships for
U.S. federal income tax purposes) or persons that hold their common
stock through such partnerships or such entities or arrangements.
If a partnership, including any entity or arrangement treated as a
partnership for U.S. federal income tax purposes, holds shares of
our common stock, the U.S. federal income tax treatment of a
partner in such partnership will generally depend upon the status
of the partner, the activities of the partnership and certain
determinations made at the partner level. Such partners and
partnerships should consult their own tax advisors regarding the
tax consequences of the purchase, ownership and disposition of our
common stock.
Persons
considering the purchase of our common stock pursuant to this
offering should consult their own tax advisors concerning the U.S.
federal income, estate, and other tax consequences of acquiring,
owning and disposing of our common stock in light of their
particular situations as well as any consequences arising under the
laws of any other taxing jurisdiction, including any state, local
or foreign tax consequences.
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For the
purposes of this discussion, a "Non-U.S. Holder" is, for U.S.
federal income tax purposes, a beneficial owner of common stock
that is neither a U.S. Holder, nor a partnership (or other entity
treated as a partnership for U.S. federal income tax purposes
regardless of its place of organization or formation). A "U.S.
Holder" means a beneficial owner of our common stock that is for
U.S. federal income tax purposes (1) an individual who is a
citizen or resident of the United States, (2) a corporation or
other entity treated as a corporation created or organized in or
under the laws of the United States, any state thereof or the
District of Columbia, (3) an estate the income of which is
subject to U.S. federal income taxation regardless of its source or
(4) a trust if it (a) is subject to the primary
supervision of a court within the United States and one or more
U.S. persons have the authority to control all substantial
decisions of the trust or (b) has a valid election in effect
under applicable U.S. Treasury regulations to be treated as a U.S.
person.
Distributions
Distributions,
if any, made on our common stock to a Non-U.S. Holder of our common
stock to the extent made out of our current or accumulated earnings
and profits (as determined under U.S. federal income tax
principles) will constitute dividends for U.S. tax
purposes.
Subject to the
discussion below regarding effectively connected income, backup
withholding and FATCA withholding, dividends will be subject to
withholding tax at a 30% rate or such lower rate as may be
specified by an applicable income tax treaty. To obtain a reduced
rate of withholding under a treaty, a Non-U.S. Holder generally
will be required to provide us with a properly executed IRS
Form W-8BEN (in the case of individuals), IRS
Form W-8BEN-E (in the case of entities), or other appropriate
form, certifying the Non-U.S. Holder's entitlement to benefits
under that treaty. This certification must be provided to us or our
paying agent prior to the payment of dividends. If a Non-U.S.
Holder holds stock through a financial institution or other agent
acting on the holder's behalf, the holder will be required to
provide appropriate documentation to such agent. The holder's agent
will then be required to provide certification to us or our paying
agent, either directly or through other intermediaries. If you are
eligible for a reduced rate of U.S. federal withholding tax under
an income tax treaty and you do not timely provide the required
certification, you may be able to obtain a refund or credit of any
excess amounts withheld by timely filing an appropriate claim for a
refund with the IRS.
If a non-U.S.
holder holds our common stock in connection with the conduct of a
trade or business in the United States, and dividends paid on our
common stock are effectively connected with such holder's U.S.
trade or business (and the Non-U.S. holder does not claim a valid
exemption from U.S. tax under an applicable tax treaty based on
such dividends being not attributable to a permanent establishment
maintained in the United States by such holder), the non-U.S.
holder will be exempt from U.S. federal withholding tax. To claim
the exemption, the non-U.S. holder must generally furnish to us or
our paying agent a properly executed IRS Form W-8ECI (or
applicable successor form). In general, such effectively connected
dividends will be subject to U.S. federal income tax, on a net
income basis at the regular rates applicable to U.S. residents. A
non-U.S. holder that is a foreign corporation also may be subject
to an additional branch profits tax equal to 30% (or such lower
rate specified by an applicable income tax treaty) of its
effectively connected earnings and profits for the taxable year, as
adjusted for certain items. Non-U.S. Holders should consult their
tax advisors regarding any applicable income tax treaties that may
provide for different rules.
To the extent
distributions on our common stock, if any, exceed our current and
accumulated earnings and profits, they will first reduce the
Non-U.S. Holder's adjusted basis in our common stock, but not below
zero, and then will be treated as gain to the extent of any excess,
and taxed in
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the same manner as
gain realized from a sale or other disposition of common stock as
described in the next section. See the discussion below in "Gain on
Disposition of Our Common Stock."
Non-U.S.
Holders may be required to periodically update their IRS
Forms W-8.
Gain on Disposition of Our Common Stock
Subject to the
discussion below regarding backup withholding and FATCA
withholding, a Non-U.S. Holder generally will not be subject to
U.S. federal income tax with respect to gain realized on a sale or
other disposition of our common stock unless (1) the gain is
effectively connected with a trade or business of such holder in
the United States (and the Non-U.S. holder does not claim a valid
exemption from U.S. tax under an applicable tax treaty based on
such dividends being not attributable to a permanent establishment
maintained in the United States by such holder), in which case the
Non-U.S. Holder generally will be taxed on a net income basis in
the same manner as if the Non-U.S. Holder were a U.S. person as
defined under the Code (and at the U.S. federal income tax rates
applicable to such U.S. persons (as defined in the Code)) and, if
the Non-U.S. Holder is a foreign corporation, the branch profits
tax described above in "Distributions" may also apply; (2) the
Non-U.S. Holder is a nonresident alien individual and is present in
the United States for 183 or more days in the taxable year of the
disposition and certain other conditions are met, in which case the
Non-U.S. Holder will be subject to a 30% tax (or such lower rate as
may be specified by an applicable income tax treaty) on the net
gain derived from the disposition, which may be offset by any
U.S.-source capital losses of the Non-U.S. Holder, provided the
Non-U.S. Holder has timely filed U.S. federal income tax returns
with respect to such losses; or (3) we are or have been a
"United States real property holding corporation" within the
meaning of Code Section 897(c)(2) at any time within the
shorter of the five-year period preceding such disposition or such
holder's holding period. In general, we would be a U.S. real
property holding corporation if the fair market value of our U.S.
real property interests equals or exceeds 50% of the sum of the
fair market value of our worldwide real property interests plus any
of our assets used or held for use in a trade or business. We
believe that we are not, and do not anticipate becoming, a U.S.
real property holding corporation. However, because the
determination of whether we are a U.S. real property holding
corporation depends on the fair market value of our assets
classified as U.S. real property for U.S. income tax purposes
relative to the fair market value of our other business assets,
there can be no assurance that we will not become a U.S. real
property holding corporation in the future. Even if we are treated
as a U.S. real property holding corporation, gain realized by a
Non-U.S. Holder on a disposition of our common stock will not be
subject to U.S. federal income tax so long as (a) the Non-U.S.
Holder owned, directly, indirectly or constructively, no more than
five percent of our common stock at all times within the shorter of
(i) the five-year period preceding the disposition or
(ii) the holder's holding period and (b) our common stock
is regularly traded on an established securities market. There can
be no assurance that our common stock will qualify as regularly
traded on an established securities market. If any gain on your
disposition is taxable because we are a U.S. real property holding
corporation and your ownership of our common stock exceeds 5%, you
will be taxed on such disposition generally in the manner
applicable to U.S. persons.
Information Reporting Requirements and Backup
Withholding
Generally, we
must report information to the IRS with respect to any
distributions we pay on our common stock (even if the payments are
not dividends subject to withholding) including the amount of any
such distributions, the name and address of the recipient, and the
amount, if any, of tax withheld. A similar report is sent to the
holder to whom any such dividends are paid. Pursuant to tax
treaties or certain other agreements, the IRS may make its reports
available to tax authorities in the recipient's country of
residence.
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Dividends paid
by us (or our paying agents) to a Non-U.S. Holder may also be
subject to U.S. backup withholding. U.S. backup withholding
generally will not apply to a Non-U.S. Holder who furnishes the
required certification as to its non-U.S. status, such as by
providing a properly executed IRS Form W-8BEN (in the case of
individuals), IRS Form W-8BEN-E (in the case of entities), IRS
Form W-8ECI, or otherwise establishes an exemption.
Notwithstanding the foregoing, backup withholding may apply if the
payor has actual knowledge, or reason to know, that the holder is a
U.S. person who is not an exempt recipient.
Back-up
withholding is not an additional tax. If any amount is withheld
under the backup withholding rules, the Non-U.S. Holder should
consult with a U.S. tax advisor regarding the possibility of and
procedure for obtaining a refund or a credit against the Non-U.S.
Holder's U.S. federal income tax liability, if any.
Non-U.S.
Holders should consult with their own tax advisors regarding the
application of the information reporting and backup withholding
rules to them.
Foreign Accounts/FATCA Withholding
Sections 1471
through 1474 of the Code and related Treasury Regulations (commonly
referred to as "FATCA") generally impose a U.S. federal withholding
tax of 30% on dividends on and, subject to the discussion of
certain proposed Treasury Regulations below, the gross proceeds of
a disposition of our common stock paid to a foreign financial
institution (as specifically defined by applicable rules) unless
such institution enters into an agreement with the U.S. government
to withhold on certain payments and to collect and provide to the
U.S. tax authorities substantial information regarding U.S. account
holders of such institution (which includes certain equity and debt
holders of such institution, as well as certain account holders
that are foreign entities with U.S. owners). This U.S. federal
withholding tax of 30% will also apply to dividends on and, subject
to the discussion of certain proposed Treasury Regulations below,
the gross proceeds of a disposition of our common stock to a
non-financial foreign entity unless such entity provides the
withholding agent with either a certification that it does not have
any substantial direct or indirect U.S. owners or provides
information regarding substantial direct and indirect U.S. owners
of the entity. Foreign financial institutions located in
jurisdictions that have an intergovernmental agreement with the
United States governing these withholding and reporting
requirements may be subject to different rules.
The U.S.
Treasury proposed Treasury Regulations in December 2018, which, if
finalized in their present form, would eliminate the federal
withholding tax of 30% applicable to the gross proceeds of a sale
or other disposition of our common stock. In its preamble to such
proposed Treasury Regulations, the U.S. Treasury stated that
taxpayers may generally rely on the proposed regulations until
final regulations are issued.
The withholding
tax described above will not apply if the foreign financial
institution or non-financial foreign entity otherwise qualifies for
an exemption from the rules. Under certain circumstances, a
Non-U.S. Holder might be eligible for refunds or credits of such
taxes. Holders are encouraged to consult with their own tax
advisors regarding the possible implications of these rules to
their investment in our common stock.
EACH
PROSPECTIVE INVESTOR SHOULD CONSULT ITS OWN TAX ADVISOR REGARDING
THE TAX CONSEQUENCES OF PURCHASING, HOLDING AND DISPOSING OF OUR
COMMON STOCK, INCLUDING THE CONSEQUENCES OF ANY PROPOSED CHANGE IN
APPLICABLE LAW, AS WELL AS TAX CONSEQUENCES ARISING UNDER ANY
STATE, LOCAL OR U.S. FEDERAL TAX LAWS.
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UNDERWRITING
We and the
underwriters for the offering named below have entered into an
underwriting agreement with respect to the common stock being
offered. Subject to the terms and conditions of the underwriting
agreement, each underwriter has severally agreed to purchase from
us the number of shares of our common stock set forth opposite its
name below. Cowen and Company, LLC and William
Blair & Company, L.L.C. are the representatives of the
underwriters.
|
|
|
|
|
Underwriter
|
|
Number
of
Shares |
|
Cowen and Company, LLC
|
|
|
1,600,000 |
|
William Blair & Company,
L.L.C.
|
|
|
1,200,000 |
|
Wedbush Securities Inc.
|
|
|
440,000 |
|
H.C. Wainwright & Co., LLC
|
|
|
440,000 |
|
Robert W. Baird & Co. Incorporated
|
|
|
320,000 |
|
Total
|
|
|
4,000,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The
underwriting agreement provides that the obligations of the
underwriters are subject to certain conditions precedent and that
the underwriters have agreed, severally and not jointly, to
purchase all of the shares sold under the underwriting agreement if
any of these shares are purchased, other than those shares covered
by the option to purchase additional shares described below. If an
underwriter defaults, the underwriting agreement provides that the
purchase commitments of the non-defaulting underwriters may be
increased or the underwriting agreement may be
terminated.
We have agreed
to indemnify the underwriters against specified liabilities,
including liabilities under the Securities Act, and to contribute
to payments the underwriters may be required to make in respect
thereof.
The
underwriters are offering the shares, subject to prior sale, when,
as and if issued to and accepted by them, subject to approval of
legal matters by their counsel and other conditions specified in
the underwriting agreement. The underwriters reserve the right to
withdraw, cancel or modify offers to the public and to reject
orders in whole or in part.
Option to
Purchase Additional Shares. We have granted to the underwriters an
option to purchase up to 600,000 additional shares of common stock
at the public offering price, less the underwriting discount and
commissions. This option is exercisable for a period of
30 days. To the extent that the underwriters exercise this
option, the underwriters will purchase additional shares from us in
approximately the same proportion as shown in the table
above.
Discounts
and Commissions. The following table shows the public
offering price, underwriting discounts and commissions, and
proceeds, before expenses, to us. These amounts are shown assuming
both no exercise and full exercise of the underwriters' option to
purchase additional shares.
We estimate
that the total expenses of the offering, excluding underwriting
discounts and commissions, will be approximately $350,000 and are
payable by us. We have agreed to reimburse
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the underwriters for
up to $30,000 for their FINRA counsel fee. In accordance with FINRA
Rule 5110, this reimbursed fee is deemed underwriting
compensation for this offering.
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
Per Share |
|
Without
Option |
|
With
Option |
|
Public offering price
|
|
$ |
40.00 |
|
$ |
160,000,000 |
|
$ |
184,000,000 |
|
Underwriting discounts and commissions
|
|
$ |
2.40 |
|
$ |
9,600,000 |
|
$ |
11,040,000 |
|
Proceeds, before expenses, to Albireo
|
|
$ |
37.60 |
|
$ |
150,400,000 |
|
$ |
172,960,000 |
|
The
underwriters propose to offer the shares of common stock to the
public at the public offering price set forth on the cover of this
prospectus supplement. The underwriters may offer the shares of
common stock to securities dealers at the public offering price
less a concession not in excess of $1.44 per share. If all of the
shares are not sold at the public offering price, the underwriters
may change the offering price and other selling terms.
Discretionary
Accounts. The
underwriters do not intend to confirm sales of the shares to any
accounts over which they have discretionary authority.
Stabilization. In
connection with this offering, the underwriters may engage in
stabilizing transactions, overallotment transactions, syndicate
covering transactions, penalty bids and purchases to cover
positions created by short sales.
- §
- Stabilizing
transactions permit bids to purchase shares of common stock so long
as the stabilizing bids do not exceed a specified maximum, and are
engaged in for the purpose of preventing or retarding a decline in
the market price of the common stock while the offering is in
progress.
- §
- Overallotment
transactions involve sales by the underwriters of shares of common
stock in excess of the number of shares the underwriters are
obligated to purchase. This creates a syndicate short position
which may be either a covered short position or a naked short
position. In a covered short position, the number of shares
over-allotted by the underwriters is not greater than the number of
shares that they may purchase in the option to purchase additional
shares. In a naked short position, the number of shares involved is
greater than the number of shares in the option to purchase
additional shares. The underwriters may close out any short
position by exercising their option to purchase additional shares
and/or purchasing shares in the open market.
- §
- Syndicate covering
transactions involve purchases of common stock in the open market
after the distribution has been completed in order to cover
syndicate short positions. In determining the source of shares to
close out the short position, the underwriters will consider, among
other things, the price of shares available for purchase in the
open market as compared with the price at which they may purchase
shares through exercise of the option to purchase additional
shares. If the underwriters sell more shares than could be covered
by exercise of the option to purchase additional shares and,
therefore, have a naked short position, the position can be closed
out only by buying shares in the open market. A naked short
position is more likely to be created if the underwriters are
concerned that after pricing there could be downward pressure on
the price of the shares in the open market that could adversely
affect investors who purchase in the offering.
- §
- Penalty bids permit
the representatives to reclaim a selling concession from a
syndicate member when the common stock originally sold by that
syndicate member is purchased in stabilizing or syndicate covering
transactions to cover syndicate short positions.
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These
stabilizing transactions, syndicate covering transactions and
penalty bids may have the effect of raising or maintaining the
market price of our common stock or preventing or retarding a
decline in the market price of our common stock. As a result, the
price of our common stock in the open market may be higher than it
would otherwise be in the absence of these transactions. Neither we
nor the underwriters make any representation or prediction as to
the effect that the transactions described above may have on the
price of our common stock. These transactions may be effected on
the Nasdaq Stock Market, in the over-the-counter market or
otherwise and, if commenced, may be discontinued at any
time.
Passive
Market Making. In
connection with this offering, underwriters and selling group
members may engage in passive market making transactions in our
common stock on the Nasdaq Stock Market in accordance with
Rule 103 of Regulation M under the Exchange Act during a
period before the commencement of offers or sales of common stock
and extending through the completion of the distribution. A passive
market maker must display its bid at a price not in excess of the
highest independent bid of that security. However, if all
independent bids are lowered below the passive market maker's bid,
such bid must then be lowered when specified purchase limits are
exceeded.
Lock-Up
Agreements. Pursuant to certain "lock-up"
agreements, we, our executive officers and our directors have
agreed, subject to certain exceptions, not to offer, sell, assign,
transfer, pledge, contract to sell, or otherwise dispose of or
announce the intention to otherwise dispose of, or enter into any
swap, hedge or similar agreement or arrangement that transfers, in
whole or in part, the economic consequence of ownership of,
directly or indirectly, or make any demand or request or exercise
any right with respect to the registration of, or file with the SEC
a registration statement under the Securities Act relating to, any
common stock or securities convertible into or exchangeable or
exercisable for any common stock without the prior written consent
of Cowen and Company, LLC and William Blair &
Company, L.L.C., for a period of 90 days after the date of the
pricing of the offering.
This lock-up
provision applies to common stock and to securities convertible
into or exchangeable or exercisable for common stock. The
exceptions permit us, among other things and subject to
restrictions, to: (a) issue common stock, options and other
securities pursuant to employee benefit plans, (b) issue
common stock upon exercise of outstanding options or warrants,
(c) adopt a new equity incentive plan or amend an existing
equity incentive plan and issue securities pursuant to such plans,
(d) file registration statements on Form S-8, or
(e) after the 60th day following the date of the pricing
of the offering, sell shares of common stock pursuant to the
at-the-market offering program sales agreement we entered into with
Cowen and Company, LLC in May 2020. The exceptions permit
parties to the "lock-up" agreements, among other things and subject
to restrictions, to: (a) make certain gifts, (b) if the
party is a corporation, partnership, limited liability company or
other business entity, make transfers to any shareholders,
partners, members of, or owners of similar equity interests in, the
party, or to an affiliate of the party, if such transfer is not for
value, (c) if the party is a corporation, partnership, limited
liability company or other business entity, make transfers in
connection with the sale or transfer of all of the party's capital
stock, partnership interests, membership interests or other similar
equity interests, as the case may be, or all or substantially all
of the party's assets, in any such case not undertaken for the
purpose of avoiding the restrictions imposed by the "lock-up"
agreement, (d) enter into a 10b5-1 trading plan, provided,
however, that such plan does not provide for the sale of common
stock during the lock-up period, (e) transfer common stock to
the Company to satisfy tax withholding obligations pursuant to the
Company's equity incentive plans, (f) participate in any third
party tender offer, merger, consolidation or similar transaction
involving a change of control of the Company and (g) sell
common stock pursuant to an existing 10b5-1 trading plan or
arrangement.
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Cowen and
Company, LLC and William Blair &
Company, L.L.C., in their sole discretion, may release our
common stock and other securities subject to the lock-up agreements
described above in whole or in part at any time. When determining
whether or not to release our common stock and other securities
from lock-up agreements, Cowen and Company, LLC and William
Blair & Company, L.L.C. will consider, among other
factors, the holder's reasons for requesting the release, the
number of shares for which the release is being requested and
market conditions at the time of the request.
Selling Restrictions
Canada. The
common stock may be sold only to purchasers purchasing, or deemed
to be purchasing, as principal that are accredited investors, as
defined in National Instrument 45-106 Prospectus Exemptions or
subsection 73.3(1) of the Securities
Act (Ontario), and are permitted clients,
as defined in National Instrument 31-103 Registration Requirements, Exemptions and Ongoing Registrant
Obligations. Any resale of the common
stock must be made in accordance with an exemption from, or in a
transaction not subject to, the prospectus requirements of
applicable securities laws.
Securities
legislation in certain provinces or territories of Canada may
provide a purchaser with remedies for rescission or damages if this
prospectus supplement (including any amendment thereto) contains a
misrepresentation, provided that the remedies for rescission or
damages are exercised by the purchaser within the time limit
prescribed by the securities legislation of the purchaser's
province or territory. The purchaser should refer to any applicable
provisions of the securities legislation of the purchaser's
province or territory for particulars of these rights or consult
with a legal advisor.
Pursuant to
section 3A.3 of National Instrument 33-105
Underwriting Conflicts (NI 33-105), the underwriters are not required to comply
with the disclosure requirements of NI 33-105 regarding
underwriter conflicts of interest in connection with this
offering.
Switzerland. The
securities will not be offered, directly or indirectly, to the
public in Switzerland and this prospectus does not constitute a
public offering prospectus as that term is understood pursuant to
article 652a or 1156 of the Swiss Federal Code of
Obligations.
European
Economic Area and the United Kingdom. In relation to each Member State of the
European Economic Area and the United Kingdom (each, a "Member
State"), no shares have been offered or will be offered pursuant to
the offering to the public in that Member State prior to the
publication of a prospectus in relation to the shares which has
been approved by the competent authority in that Member State or,
where appropriate, approved in another Member State and notified to
the competent authority in that Member State, all in accordance
with the Prospectus Regulation, except that offers of shares may be
made to the public in that Member State at any time under the
following exemptions under the Prospectus Regulation:
A. to
any legal entity which is a qualified investor as defined under the
Prospectus Regulation;
B. to
fewer than 150 natural or legal persons (other than qualified
investors as defined under the Prospectus Regulation), subject to
obtaining the prior consent of the underwriters; or
C. in
any other circumstances falling within Article 1(4) of the
Prospectus Regulation,
provided that no such
offer of shares shall require the Company or any underwriter to
publish a prospectus pursuant to Article 3 of the Prospectus
Regulation or supplement a prospectus pursuant to Article 23
of the Prospectus Regulation and each person who initially acquires
any shares or to
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whom any offer is made
will be deemed to have represented, acknowledged and agreed to and
with each of the underwriters and the Company that it is a
"qualified investor" within the meaning of Article 2(e) of the
Prospectus Regulation.
In the case of
any shares being offered to a financial intermediary as that term
is used in Prospectus Regulation, each such financial intermediary
will be deemed to have represented, acknowledged and agreed that
the shares acquired by it in the offer have not been acquired on a
non-discretionary basis on behalf of, nor have they been acquired
with a view to their offer or resale to, persons in circumstances
which may give rise to an offer of any shares to the public other
than their offer or resale in a Member State to qualified investors
as so defined or in circumstances in which the prior consent of the
underwriters have been obtained to each such proposed offer or
resale.
For the
purposes of this provision, the expression an "offer to the public"
in relation to shares in any Member State means the communication
in any form and by any means of sufficient information on the terms
of the offer and any shares to be offered so as to enable an
investor to decide to purchase or subscribe for any shares, and the
expression "Prospectus Regulation" means Regulation (EU)
2017/1129.
References to
the Prospectus Regulation includes, in relation to the United
Kingdom, the Prospectus Regulation as it forms part of the United
Kingdom domestic law by virtue of the European Union (Withdrawal)
Act of 2018.
United
Kingdom. In
addition, in the United Kingdom, this document is being distributed
only to, and is directed only at, and any offer subsequently made
may only be directed at persons who are "qualified investors" (as
defined in the Prospectus Regulation) (i) who have
professional experience in matters relating to investments falling
within Article 19(5) of the Financial Services and Markets Act
2000 (Financial Promotion) Order 2005, as amended (the "Order")
and/or (ii) who are high net worth companies (or persons to
whom it may otherwise be lawfully communicated) falling within
Article 49(2)(a) to (d) of the Order and/or (iii) to
whom it may otherwise be lawfully communicated (all such persons
together being referred to as "relevant persons") in circumstances
which have not resulted and will not result in an offer to the
public of the shares in the United Kingdom within the meaning of
the Financial Services and Markets Act 2000.
Any person in
the United Kingdom that is not a relevant person should not act or
rely on the information included in this document or use it as
basis for taking any action. In the United Kingdom, any investment
or investment activity that this document relates to may be made or
taken exclusively by relevant persons.
Hong
Kong. The shares
have not been offered or sold and will not be offered or sold in
Hong Kong, by means of any document, other than (a) to
"professional investors" as defined in the Securities and Futures
Ordinance (Cap. 571 of the Laws of Hong Kong) (the "SFO") of
Hong Kong and any rules made thereunder; or (b) in other
circumstances which do not result in the document being a
"prospectus" as defined in the Companies (Winding Up and
Miscellaneous Provisions) Ordinance (Cap. 32) of Hong
Kong) (the "CO"), or which do not constitute an offer to the public
within the meaning of the CO. No advertisement, invitation or
document relating to the shares has been or may be issued or has
been or may be in the possession of any person for the purposes of
issue, whether in Hong Kong or elsewhere, which is directed at, or
the contents of which are likely to be accessed or read by, the
public of Hong Kong (except if permitted to do so under the
securities laws of Hong Kong) other than with respect to shares
which are or are intended to be disposed of only to persons outside
Hong Kong or only to "professional investors" as defined in the SFO
and any rules made thereunder.
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Singapore. Each
underwriter has acknowledged that this prospectus has not been
registered as a prospectus with the Monetary Authority of
Singapore. Accordingly, each underwriter has represented and agreed
that it has not offered or sold any shares or caused the shares to
be made the subject of an invitation for subscription or purchase
and will not offer or sell any shares or cause the shares to be
made the subject of an invitation for subscription or purchase, and
has not circulated or distributed, nor will it circulate or
distribute, this prospectus or any other document or material in
connection with the offer or sale, or invitation for subscription
or purchase, of the shares, whether directly or indirectly, to any
person in Singapore other than:
A. to
an institutional investor (as defined in Section 4A of the
Securities and Futures Act (Chapter 289) of Singapore, as
modified or amended from time to time (the "SFA")) pursuant to
Section 274 of the SFA;
B. to
a relevant person (as defined in Section 275(2) of the SFA)
pursuant to Section 275(1) of the SFA, or any person pursuant
to Section 275(1A) of the SFA, and in accordance with the
conditions specified in Section 275 of the SFA; or
C. otherwise
pursuant to, and in accordance with the conditions of, any other
applicable provision of the SFA.
Where the
shares are subscribed or purchased under Section 275 of the
SFA by a relevant person which is:
A. a
corporation (which is not an accredited investor (as defined in
Section 4A of the SFA)) the sole business of which is to hold
investments and the entire share capital of which is owned by one
or more individuals, each of whom is an accredited investor;
or
B. a
trust (where the trustee is not an accredited investor) whose sole
purpose is to hold investments and each beneficiary of the trust is
an individual who is an accredited investor,
securities or
securities-based derivatives contracts (each term as defined in
Section 2(1) of the SFA) of that corporation or the
beneficiaries' rights and interest (however described) in that
trust shall not be transferred within six months after that
corporation or that trust has acquired the shares pursuant to an
offer made under Section 275 of the SFA except:
(i) to
an institutional investor or to a relevant person, or to any person
arising from an offer referred to in Section 275(1A) or
Section 276(4)(i)(B) of the SFA;
(ii) where
no consideration is or will be given for the transfer;
(iii) where
the transfer is by operation of law;
(iv) as
specified in Section 276(7) of the SFA; or
(v) as
specified in Regulation 37A of the Securities and Futures
(Offers of Investments) (Securities and Securities-based
Derivatives Contracts) Regulations 2018.
Singapore SFA
Product Classification—In connection with Section 309B of the
SFA and the CMP Regulations 2018, unless otherwise specified
before an offer of shares, we have determined, and hereby notify
all relevant persons (as defined in Section 309A(1) of the
SFA), that the shares are "prescribed capital markets products" (as
defined in the CMP Regulations 2018) and Excluded Investment
Products (as defined in MAS Notice SFA 04-N12: Notice on the
Sale of Investment Products and MAS Notice FAA-N16: Notice on
Recommendations on Investment Products).
Israel. In
the State of Israel this prospectus supplement shall not be
regarded as an offer to the public to purchase shares of common
stock under the Israeli Securities Law, 5728 - 1968,
which requires a prospectus to be published and authorized by the
Israel Securities Authority, if it complies with certain provisions
of Section 15 of the Israeli Securities Law,
5728 - 1968, including, inter alia,
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if: (i) the offer
is made, distributed or directed to not more than 35 investors,
subject to certain conditions (the "Addressed Investors"); or
(ii) the offer is made, distributed or directed to certain
qualified investors defined in the First Addendum of the Israeli
Securities Law, 5728 - 1968, subject to certain
conditions (the "Qualified Investors"). The Qualified Investors
shall not be taken into account in the count of the Addressed
Investors and may be offered to purchase securities in addition to
the 35 Addressed Investors. The company has not and will not take
any action that would require it to publish a prospectus in
accordance with and subject to the Israeli Securities Law,
5728 - 1968. We have not and will not distribute this
prospectus or make, distribute or direct an offer to subscribe for
our common stock to any person within the State of Israel, other
than to Qualified Investors and up to 35 Addressed
Investors.
Qualified
Investors may have to submit written evidence that they meet the
definitions set out in of the First Addendum to the Israeli
Securities Law, 5728 - 1968. In particular, we may
request, as a condition to be offered common stock, that Qualified
Investors will each represent, warrant and certify to us and/or to
anyone acting on our behalf: (i) that it is an investor
falling within one of the categories listed in the First Addendum
to the Israeli Securities Law, 5728 - 1968;
(ii) which of the categories listed in the First Addendum to
the Israeli Securities Law, 5728 - 1968 regarding
Qualified Investors is applicable to it; (iii) that it will
abide by all provisions set forth in the Israeli Securities Law,
5728 - 1968 and the regulations promulgated thereunder in
connection with the offer to be issued common stock; (iv) that
the shares of common stock that it will be issued are, subject to
exemptions available under the Israeli Securities Law,
5728 - 1968: (a) for its own account; (b) for
investment purposes only; and (c) not issued with a view to
resale within the State of Israel, other than in accordance with
the provisions of the Israeli Securities Law,
5728 - 1968; and (v) that it is willing to provide
further evidence of its Qualified Investor status. Addressed
Investors may have to submit written evidence in respect of their
identity and may have to sign and submit a declaration containing,
inter alia, the Addressed Investor's name, address and passport
number or Israeli identification number.
We have not
authorized and do not authorize the making of any offer of
securities through any financial intermediary on our behalf, other
than offers made by the underwriters and their respective
affiliates, with a view to the final placement of the securities as
contemplated in this document. Accordingly, no purchaser of the
shares, other than the underwriters, is authorized to make any
further offer of shares on our behalf or on behalf of the
underwriters.
Electronic
Offer, Sale and Distribution of Shares. A prospectus in electronic format may
be made available on the websites maintained by one or more of the
underwriters or selling group members, if any, participating in
this offering and one or more of the underwriters participating in
this offering may distribute prospectuses electronically. The
representatives may agree to allocate a number of shares to
underwriters and selling group members for sale to their online
brokerage account holders. Internet distributions will be allocated
by the underwriters and selling group members that will make
internet distributions on the same basis as other allocations.
Other than the prospectus in electronic format, the information on
these websites is not part of this prospectus or the registration
statement of which this prospectus forms a part, has not been
approved or endorsed by us or any underwriter in its capacity as
underwriter, and should not be relied upon by investors.
Other
Relationships. Certain of the underwriters and their
affiliates have provided, and may in the future provide, various
investment banking, commercial banking and other financial services
for us and our affiliates for which they have received, and may in
the future receive, customary fees. In addition, we entered into an
at-the-market offering program sales agreement with Cowen and
Company, LLC in May 2020. Pursuant to the sales agreement, we
may offer and sell, from time to time at our discretion, shares of
our common stock having an aggregate offering price of up to
$50 million through Cowen and Company, LLC as our sales
agent.
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LEGAL
MATTERS
The validity of
the issuance of the shares of common stock offered by us in this
offering will be passed upon for us by Mintz, Levin, Cohn, Ferris,
Glovsky and Popeo, P.C., Boston, Massachusetts. Goodwin
Procter LLP, New York, New York, is acting as counsel for the
underwriters in connection with this offering.
EXPERTS
The
consolidated financial statements of Albireo Pharma, Inc.
appearing in Albireo Pharma, Inc.'s
Annual Report (Form 10-K) for the year ended December 31,
2019, and the effectiveness of Albireo Pharma, Inc.'s
internal control over financial reporting as of December 31,
2019, have been audited by Ernst & Young LLP,
independent registered public accounting firm, as set forth in its
reports thereon, which are included therein and incorporated herein
by reference. Such financial statements have been incorporated
herein by reference in reliance upon such reports given on the
authority of such firm as experts in accounting and
auditing.
WHERE YOU CAN FIND MORE
INFORMATION
We are subject
to the reporting requirements of the Exchange Act and file annual,
quarterly and current reports, proxy statements and other
information with the SEC. SEC filings are available at the SEC's
web site at http://www.sec.gov.
We also
maintain a website at www.albireopharma.com, through which you can
access our SEC filings. The information set forth on our website is
not part of this prospectus supplement or the accompanying
prospectus.
This prospectus
supplement is part of a registration statement we filed with the
SEC. This prospectus supplement and the accompanying prospectus
omit some information contained in the registration statement in
accordance with SEC rules and regulations. You should review the
information and exhibits in the registration statement for further
information on us and our consolidated subsidiaries and the
securities we are offering. Statements in this prospectus
supplement and the accompanying prospectus concerning any document
we filed as an exhibit to the registration statement or that we
otherwise filed with the SEC are not intended to be comprehensive
and are qualified by reference to these filings. You should review
the complete document to evaluate these statements. You can obtain
a copy of the registration statement from the SEC's
website.
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INCORPORATION OF
DOCUMENTS BY REFERENCE
The SEC allows
us to "incorporate by reference" information that we file with
them. Incorporation by reference allows us to disclose important
information to you by referring you to those other documents. The
information incorporated by reference is an important part of this
prospectus supplement, and information that we file later with the
SEC will automatically update and supersede this information. We
filed a registration statement on Form S-3 under the
Securities Act with the SEC with respect to the securities we may
offer pursuant to this prospectus supplement. This prospectus
supplement omits certain information contained in the registration
statement, as permitted by the SEC. You should refer to the
registration statement, including the exhibits, for further
information about us and the securities we may offer pursuant to
this prospectus supplement. Statements in this prospectus
supplement regarding the provisions of certain documents filed
with, or incorporated by reference in, the registration statement
are not necessarily complete and each statement is qualified in all
respects by that reference. Copies of all or any part of the
registration statement, including the documents incorporated by
reference or the exhibits, are available at the SEC's web site at
http://www.sec.gov. The documents we are incorporating by reference
are:
- §
-
our Annual Report on Form 10-K for the year
ended December 31, 2019 that we filed with the SEC on
March 2, 2020;
- §
-
the portions of our definitive proxy statement on
Schedule 14A that we filed with the SEC on April 17, 2020
that are deemed "filed" with the SEC under the Exchange
Act;
- §
- our
Quarterly Report on Form 10-Q for the quarter ended
March 31, 2020 that we filed with the SEC on May 7,
2020 and our
Quarterly Report on Form 10-Q for the quarter ended
June 30, 2020 that we filed with the SEC on August 6,
2020;
- §
- our Current Reports
on Form 8-K that we filed with the SEC on
January 29, 2020,
January 29, 2020,
January 30, 2020,
February 3, 2020,
March 26, 2020,
May 7, 2020,
June 9, 2020,
June 15, 2020,
August 18, 2020,
September 8, 2020,
September 8, 2020 and
September 9, 2020 (except for the information furnished
under Items 2.02 or 7.01 and the exhibits furnished
thereto);
- §
-
the description of our common stock contained in our
Registration Statement on Form 8-A that we filed with the SEC
on May 8, 2007, including any amendment or report filed for
the purpose of updating such description; and
- §
- all reports and other
documents subsequently filed by us pursuant to Sections 13(a),
13(c), 14 and 15(d) of the Exchange Act after the date of this
prospectus supplement and prior to the termination or completion of
the offering of securities under this prospectus supplement shall
be deemed to be incorporated by reference in this prospectus
supplement and to be a part hereof from the date of filing such
reports and other documents.
The SEC file
number for each of the documents listed above is
001-33451.
Any statement
contained in this prospectus supplement or the accompanying
prospectus or in a document incorporated or deemed to be
incorporated by reference into this prospectus supplement or in the
accompanying prospectus will be deemed to be modified or superseded
for purposes of this prospectus supplement and the accompanying
prospectus to the extent that a statement contained in this
prospectus supplement or the accompanying prospectus or any other
subsequently filed document that is deemed to be incorporated by
reference into this prospectus supplement or the accompanying
prospectus modifies or supersedes the statement. Any statement so
modified or superseded will not be deemed, except as so modified or
superseded, to constitute a part of this prospectus supplement or
the accompanying prospectus.
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You may
request, orally or in writing, a copy of any or all of the
documents incorporated herein by reference. These documents will be
provided to you at no cost, by contacting:
Albireo
Pharma, Inc.
10 Post Office Square, Suite 1000
Boston, Massachusetts 02109
Telephone: (857) 254-5555
You may also
access these documents on our website,
http://www.albireopharma.com. The information contained on, or that
can be accessed through, our website is not a part of this
prospectus supplement. We have included our website address in this
prospectus supplement solely as an inactive textual
reference.
You should rely
only on information contained in, or incorporated by reference
into, this prospectus supplement and the accompanying prospectus.
We have not authorized anyone to provide you with information
different from that contained in this prospectus supplement or the
accompanying prospectus or incorporated by reference in this
prospectus supplement or the accompanying prospectus. We are not
making offers to sell the securities in any jurisdiction in which
such an offer or solicitation is not authorized or in which the
person making such offer or solicitation is not qualified to do so
or to anyone to whom it is unlawful to make such offer or
solicitation.
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PROSPECTUS
Albireo Pharma, Inc.
$200,000,000
COMMON STOCK
PREFERRED STOCK
DEBT SECURITIES
WARRANTS
RIGHTS
UNITS
This prospectus
will allow us to issue, from time to time at prices and on terms to
be determined at or prior to the time of the offering, up to
$200,000,000 of any combination of the securities described in this
prospectus, either individually or in units. We may also offer:
common stock or preferred stock upon conversion of or exchange for
the debt securities; common stock upon conversion of or exchange
for the preferred stock; or common stock, preferred stock or debt
securities upon the exercise of warrants or rights.
This prospectus
describes the general terms of these securities and the general
manner in which these securities will be offered. We will provide
you with the specific terms of any offering in one or more
supplements to this prospectus. The prospectus supplements will
also describe the specific manner in which these securities will be
offered and may also supplement, update or amend information
contained in this document. You should read this prospectus and any
prospectus supplement, as well as any documents incorporated by
reference into this prospectus or any prospectus supplement,
carefully before you invest.
Our securities
may be sold directly by us to you, through agents designated from
time to time or to or through underwriters or dealers. For
additional information on the methods of sale, you should refer to
the section entitled "Plan of Distribution" in this prospectus and
in the applicable prospectus supplement. If any underwriters or
agents are involved in the sale of our securities with respect to
which this prospectus is being delivered, the names of such
underwriters or agents and any applicable fees, commissions or
discounts and over-allotment options will be set forth in a
prospectus supplement. The price to the public of such securities
and the net proceeds that we expect to receive from such sale will
also be set forth in a prospectus supplement.
Our common
stock is listed on The Nasdaq Capital Market under the symbol
"ALBO." On May 6, 2020, the last reported sale price of our
common stock was $24.86 per share. The applicable prospectus
supplement will contain information, where applicable, as to any
other listing on The Nasdaq Capital Market or any securities market
or other securities exchange of the securities covered by the
prospectus supplement. Prospective purchasers of our securities are
urged to obtain current information as to the market prices of our
securities, where applicable.
Investing
in our securities involves a high degree of risk. Before deciding
whether to invest in our securities, you should consider carefully
the risks that we have described on page 5 of this prospectus
under the caption "Risk Factors." We may also include specific risk
factors in supplements to this prospectus under the caption "Risk
Factors." This prospectus may not be used to sell our securities
unless accompanied by a prospectus supplement.
Neither the
Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or
determined if this prospectus is truthful or complete. Any
representation to the contrary is a criminal offense.
The
date of this prospectus is May 18, 2020.
Table of
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TABLE OF CONTENTS
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ABOUT THIS PROSPECTUS
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1 |
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PROSPECTUS SUMMARY
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2 |
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RISK FACTORS
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5 |
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SPECIAL NOTE REGARDING FORWARD-LOOKING
STATEMENTS
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6 |
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USE OF PROCEEDS
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PLAN OF DISTRIBUTION
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DESCRIPTION OF COMMON STOCK
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12 |
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DESCRIPTION OF PREFERRED STOCK
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13 |
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DESCRIPTION OF DEBT SECURITIES
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DESCRIPTION OF WARRANTS
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DESCRIPTION OF RIGHTS
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DESCRIPTION OF UNITS
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CERTAIN PROVISIONS OF DELAWARE LAW AND OF THE
COMPANY'S CERTIFICATE OF INCORPORATION AND BYLAWS
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LEGAL MATTERS
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EXPERTS
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WHERE YOU CAN FIND MORE INFORMATION
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INCORPORATION OF DOCUMENTS BY REFERENCE
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ABOUT THIS
PROSPECTUS
This prospectus
is part of a registration statement that we filed with the
Securities and Exchange Commission, or SEC, utilizing a "shelf"
registration process. Under this shelf registration process, we may
offer shares of our common stock or preferred stock, various series
of debt securities and/or warrants or rights to purchase any of
such securities, either individually or in units, in one or more
offerings, with a total value of up to $200,000,000. This
prospectus provides you with a general description of the
securities we may offer. Each time we offer a type or series of
securities under this prospectus, we will provide a prospectus
supplement that will contain specific information about the terms
of that offering.
This prospectus
does not contain all of the information included in the
registration statement. For a more complete understanding of the
offering of the securities, you should refer to the registration
statement, including its exhibits. The prospectus supplement may
also add, update or change information contained or incorporated by
reference in this prospectus. However, no prospectus supplement
will offer a security that is not registered and described in this
prospectus at the time of its effectiveness. This prospectus,
together with the applicable prospectus supplements and the
documents incorporated by reference into this prospectus, includes
all material information relating to the offering of securities
under this prospectus. You should carefully read this prospectus,
the applicable prospectus supplement, the information and documents
incorporated herein by reference and the additional information
under the headings "Where You Can Find More Information" and
"Incorporation of Documents by Reference" before making an
investment decision.
You should rely
only on the information we have provided or incorporated by
reference in this prospectus or any prospectus supplement. We have
not authorized anyone to provide you with information different
from that contained or incorporated by reference in this
prospectus. No dealer, salesperson or other person is authorized to
give any information or to represent anything not contained or
incorporated by reference in this prospectus. You must not rely on
any unauthorized information or representation. This prospectus is
an offer to sell only the securities offered hereby, but only under
circumstances and in jurisdictions where it is lawful to do so. You
should assume that the information in this prospectus or any
prospectus supplement is accurate only as of the date on the front
of the document and that any information we have incorporated
herein by reference is accurate only as of the date of the document
incorporated by reference, regardless of the time of delivery of
this prospectus or any sale of a security.
We further note
that the representations, warranties and covenants made by us in
any agreement that is filed as an exhibit to any document that is
incorporated by reference in this prospectus were made solely for
the benefit of the parties to such agreement, including, in some
cases, for the purpose of allocating risk among the parties to such
agreements, and should not be deemed to be a representation,
warranty or covenant to you. Moreover, such representations,
warranties or covenants were accurate only as of the date when
made. Accordingly, such representations, warranties and covenants
should not be relied on as accurately representing the current
state of our affairs.
This prospectus
may not be used to consummate sales of our securities unless it is
accompanied by a prospectus supplement. To the extent there are
inconsistencies between any prospectus supplement, this prospectus
and any documents incorporated by reference, the document with the
most recent date will control.
Unless the
context otherwise requires, "the Company," "we," "us," "our" and
similar terms refer to Albireo Pharma, Inc. and its direct and
indirect subsidiaries.
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PROSPECTUS
SUMMARY
The
following is a summary of what we believe to be the most important
aspects of our business and the offering of our securities under
this prospectus. We urge you to read this entire prospectus,
including the more detailed consolidated financial statements,
notes to the consolidated financial statements and other
information incorporated by reference from our other filings with
the SEC or included in any applicable prospectus supplement.
Investing in our securities involves risks. Please carefully
consider the risk factors set forth in any prospectus supplements
and in our most recent annual and quarterly filings with the SEC,
as well as other information in this prospectus and any prospectus
supplements and the documents incorporated by reference herein or
therein, before purchasing our securities. Each of the risk factors
could adversely affect our business, operating results and
financial condition, as well as adversely affect the value of an
investment in our securities.
About Albireo Pharma, Inc.
We are a
biopharmaceutical company focused on the development and
commercialization of novel bile acid modulators to treat orphan
pediatric liver diseases and other liver or gastrointestinal
diseases and disorders. The initial target indication for our lead
product candidate, odevixibat (formerly known as A4250), is
progressive familial intrahepatic cholestasis, or PFIC, a rare,
life-threatening genetic disorder affecting young children for
which there is currently no approved drug treatment. We are also
pursuing the development of odevixibat in biliary atresia and in
Alagille syndrome, or ALGS, each of which is a rare, life
threatening disease that affects the liver and for which there is
no approved pharmacologic treatment option. We initiated a pivotal
clinical trial of odevixibat in biliary atresia in the first half
of 2020 and we plan to initiate a pivotal trial in ALGS by the end
of 2020. Our most advanced product candidate in addition to
odevixibat is elobixibat, which is approved in Japan for the
treatment of chronic constipation and for which we have initiated a
Phase 2 clinical trial as a treatment for nonalcoholic fatty
liver disease, or NAFLD, and nonalcoholic steatohepatitis, or NASH.
We expect topline results from the Phase 2 trial in mid-2020.
We are also exploring additional clinical development of our
product candidate A3384 based on an evaluation of its patent
coverage and our overall portfolio. We also have a preclinical
program in adult liver disease.
Additional Information
For additional
information related to our business and operations, please refer to
the reports incorporated herein by reference, including the
Annual Report on Form 10-K of Albireo Pharma, Inc. for
the year ended December 31, 2019, as described under the
caption "Incorporation of Documents by Reference" on page 31
of this prospectus.
Our Corporate Information
Prior to
November 3, 2016, we were a specialty biopharmaceutical
company known as Biodel Inc. that historically had been
focused on the development and commercialization of innovative
treatments for diabetes. Biodel was originally incorporated in the
State of Delaware in December 2003 under the name "Global
Positioning Group, Ltd." and subsequently changed its name to
"Biodel Inc." Albireo Limited was formed in connection with a
spinout transaction from AstraZeneca AB in 2008 in which
AstraZeneca assigned to Albireo AB all of its rights in and to its
portfolio of IBAT inhibitors, including elobixibat and A4250, as
well as other preclinical assets.
On
November 3, 2016, we completed a share exchange transaction,
or the Transaction, pursuant to an Amended and Restated Share
Exchange Agreement dated July 13, 2016 that we entered into
with Albireo Limited and the shareholders and noteholders of
Albireo Limited. In the Transaction, each holder of Albireo Limited
shares or notes convertible into Albireo Limited shares sold their
shares of Albireo Limited for newly issued shares of our common
stock. As a result, Albireo Limited became a
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wholly owned
subsidiary of Biodel, Biodel's corporate name was changed to
Albireo Pharma, Inc., the business of Albireo Limited became
our business and we became a biopharmaceutical company focused on
the development and commercialization of novel bile acid modulators
to treat orphan pediatric liver diseases and other liver or
gastrointestinal diseases and disorders.
Our corporate
headquarters are located at 10 Post Office Square, Suite 1000,
Boston, Massachusetts 02109 and our telephone number is
(857) 254-5555. We also have an office in Gothenburg, Sweden.
We maintain a website at www.albireopharma.com, to which we
regularly post copies of our press releases as well as additional
information about us. The information contained on, or that can be
accessed through, our website is not a part of this prospectus. We
have included our website address in this prospectus solely as an
inactive textual reference.
Our Annual
Reports on Form 10-K, Quarterly Reports on Form 10-Q,
Current Reports on Form 8-K and all amendments to those
reports filed or furnished pursuant to Section 13(a) or 15(d)
of the Securities Exchange Act of 1934, as amended, or the Exchange
Act, are available free of charge through the investor relations
page of our website as soon as reasonably practicable after we
electronically file such material with, or furnish it to, the
SEC.
All brand names
or trademarks appearing in this prospectus are the property of
their respective holders. Use or display by us of other parties'
trademarks, trade dress, or products in this prospectus is not
intended to, and does not, imply a relationship with, or
endorsements or sponsorship of, us by the trademark or trade dress
owners.
Offerings under this Prospectus
Under this
prospectus, we may offer shares of our common stock or preferred
stock, various series of debt securities and/or warrants or rights
to purchase any of such securities, either individually or in
units, with a total value of up to $200,000,000, from time to time
at prices and on terms to be determined by market conditions at the
time of the offering. This prospectus provides you with a general
description of the securities we may offer. Each time we offer a
type or series of securities under this prospectus, we will provide
a prospectus supplement that will describe the specific amounts,
prices and other important terms of the securities, including, to
the extent applicable:
- •
- designation or
classification;
- •
- aggregate principal
amount or aggregate offering price;
- •
- maturity, if
applicable;
- •
- rates and times of
payment of interest or dividends, if any;
- •
- redemption,
conversion or sinking fund terms, if any;
- •
- voting or other
rights, if any; and
- •
- conversion or
exercise prices, if any.
The prospectus
supplement also may add, update or change information contained in
this prospectus or in documents we have incorporated by reference
into this prospectus. However, no prospectus supplement will
fundamentally change the terms that are set forth in this
prospectus or offer a security that is not registered and described
in this prospectus at the time of its effectiveness.
We may sell the
securities directly to investors or to or through agents,
underwriters or dealers. We, and our agents or underwriters,
reserve the right to accept or reject all or part of any proposed
purchase of securities. If we offer securities through agents or
underwriters, we will include in the applicable prospectus
supplement:
- •
- the names of those
agents or underwriters;
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- •
- applicable fees,
discounts and commissions to be paid to them;
- •
- details regarding
over-allotment options, if any; and
- •
- the net proceeds to
us.
This
prospectus may not be used to consummate a sale of any securities
unless it is accompanied by a prospectus supplement.
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RISK
FACTORS
Investing in
our securities involves significant risk. The prospectus supplement
applicable to each offering of our securities will contain a
discussion of the risks applicable to an investment in the Company.
Prior to making a decision about investing in our securities, you
should carefully consider the specific factors discussed under the
heading "Risk Factors" in the applicable prospectus supplement,
together with all of the other information contained or
incorporated by reference in the prospectus supplement or appearing
or incorporated by reference in this prospectus. You should also
consider the risks, uncertainties and assumptions discussed under
the heading "Risk Factors" included in our most recent annual
report on Form 10-K, as revised or supplemented by our
subsequent quarterly reports on Form 10-Q or our subsequent
current reports on Form 8-K that we have filed with the SEC,
all of which are incorporated herein by reference, and which may be
amended, supplemented or superseded from time to time by other
reports we file with the SEC in the future. The risks and
uncertainties we have described are not the only ones we face.
Additional risks and uncertainties not presently known to us or
that we currently deem immaterial may also affect our operations.
The occurrence of any of these risks might cause you to lose all or
part of your investment in the offered securities.
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SPECIAL NOTE
REGARDING FORWARD-LOOKING STATEMENTS
This prospectus
and the documents incorporated by reference in this prospectus
include forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, or the
Securities Act, and Section 21E of the Exchange Act that
relate to future events or to our future operations or financial
performance. Any forward-looking statement involves known and
unknown risks, uncertainties and other factors that may cause our
actual results, levels of activity, performance or achievements to
differ materially from any future results, levels of activity,
performance or achievements expressed or implied by such
forward-looking statement. Forward-looking statements include
statements, other than statements of historical fact, about, among
other things:
- •
- the progress, number,
scope, cost, duration or results of our development activities,
nonclinical studies and clinical trials of odevixibat (formerly
known as A4250), elobixibat, A3384 or any of our other product
candidates or programs, such as the target indication(s) for
development or approval, the size, design, population, conduct,
cost, objective or endpoints of any clinical trial, or the timing
for initiation or completion of or availability of results from any
clinical trial (including our Phase 2 trial of elobixibat in
patients with NAFLD and NASH; PEDFIC 1, our Phase 3 clinical
trial of odevixibat in patients with PFIC; or BOLD, our pivotal
clinical trial of odevixibat in patients with biliary atresia), for
submission or approval of any regulatory filing, or for meeting
with regulatory authorities;
- •
- the potential
benefits that may be derived from any of our product
candidates;
- •
- the timing of and our
ability to obtain and maintain regulatory approval of our existing
product candidates, any product candidates that we may develop, and
any related restrictions, limitations, or warnings in the label of
any approved product candidates;
- •
- any payment that
HealthCare Royalty Partners III, L.P., or HCR, or EA
Pharma Co., Ltd., or EA Pharma, may make to us or any
other action or decision that EA Pharma may make concerning
elobixibat or our business relationship;
- •
- the potential impacts
of the COVID-19 pandemic on our business;
- •
- our future
operations, financial position, revenues, costs, expenses, uses of
cash, capital requirements, our need for additional financing or
the period for which our existing cash resources will be sufficient
to meet our operating requirements; or
- •
- our strategies,
prospects, plans, expectations, forecasts or
objectives.
Words such as,
but not limited to, "believe," "expect," "anticipate," "estimate,"
"forecast," "intend," "may," "plan," "potential," "predict,"
"project," "targets," "likely," "will," "would," "could," "should,"
"continue," "scheduled" and similar expressions or phrases, or the
negative of those expressions or phrases, are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Although we believe
that we have a reasonable basis for each forward-looking statement
contained or incorporated by reference in this prospectus, we
caution you that these statements are based on our estimates and
projections of the future that are subject to known and unknown
risks and uncertainties and other important factors that may cause
our actual results, level of activity, performance, experience or
achievements to differ materially from those expressed or implied
by any forward-looking statement. Actual results, level of
activity, performance, experience or achievements may differ
materially from those expressed or implied by any forward-looking
statement as a result of various important factors, including our
critical accounting policies and risks and uncertainties relating,
among other things, to:
- •
- the design, size,
duration and endpoints for, and results from, PEDFIC 1, our
Phase 3 clinical trial of odevixibat in patients with PFIC or
our related extension study, or any other trials that will be
required to obtain marketing approval for odevixibat to treat
patients with PFIC, biliary
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atresia or any other
pediatric cholestatic liver disease, for elobixibat to treat NASH,
or for A3384 as a potential treatment for gastrointestinal diseases
or disorders;
- •
- whether favorable
findings from clinical trials of odevixibat to date, including
findings in indications other than PFIC, will be predictive of
results from future clinical trials, including the trials
comprising our Phase 3 PFIC program for odevixibat, pivotal
trial of odevixibat in biliary atresia and planned pivotal trial of
odevixibat in ALGS;
- •
- whether either or
both of the U.S. Food and Drug Administration, or FDA, and European
Medicines Agency, or EMA, will determine that the primary endpoint
and treatment duration of the double blind Phase 3 trial in
patients with PFIC are sufficient, even if such primary endpoint is
met with statistical significance, to support approval of
odevixibat in the United States or the European Union, to treat
PFIC, a symptom of PFIC, a specific PFIC subtype(s) or
otherwise;
- •
- the outcome and
interpretation by regulatory authorities of an ongoing third-party
study pooling and analyzing long-term PFIC patient data;
- •
- the timing for
initiation or completion of, or for availability of data from, the
trials comprising the Phase 3 PFIC program for odevixibat, and
the outcomes of such trials;
- •
- delays or other
challenges in the recruitment of patients for the pivotal trial of
odevixibat in biliary atresia and the planned pivotal trial of
odevixibat in ALGS;
- •
- whether odevixibat
will meet the criteria to receive a rare pediatric disease priority
review voucher from the FDA when applicable, whether a rare
pediatric disease priority review voucher that we may receive in
the future for odevixibat, if any, will be valuable to us, and, if
necessary, whether the rare pediatric disease priority review
voucher program will be renewed beyond 2020;
- •
- the COVID-19
pandemic, which may negatively impact the conduct of, and the
timing of initiation, enrollment, completion and reporting with
respect to, our clinical trials; negatively impact the supply of
drug product for our clinical and preclinical programs; and/or
result in other adverse impacts on our business;
- •
- the competitive
environment and commercial opportunity for a potential treatment
for PFIC and other orphan pediatric cholestatic liver
diseases;
- •
- the conduct and
results of clinical trials and nonclinical studies and assessments
of odevixibat, elobixibat, A3384 or any of our other product
candidates and programs, including the performance of third parties
engaged to execute them and difficulties or delays in patient
enrollment and data analysis;
- •
- the medical benefit
that may be derived from odevixibat, elobixibat, A3384 or any of
our other product candidates;
- •
- the extent to which
our agreements with HCR and EA Pharma for elobixibat generate
nondilutive income for us;
- •
- the timing and
success of submission, acceptance and approval of regulatory
filings and any related restrictions, limitations or warnings in
the label of any approved product candidates;
- •
- the significant
control or influence that EA Pharma has over the commercialization
of elobixibat in Japan and the development and commercialization of
elobixibat in EA Pharma's other licensed territories;
- •
- whether we elect to
seek and, if so, our ability to establish a license or other
partnering transaction with a third party for elobixibat in the
United States or Europe;
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- •
- whether findings from
nonclinical studies and clinical trials of IBAT inhibitors will be
predictive of future clinical success for a product candidate of
ours in the treatment of NASH;
- •
- the accuracy of our
estimates regarding expenses, costs, future revenues, uses of cash
and capital requirements;
- •
- our ability to obtain
additional financing on reasonable terms, or at all;
- •
- our ability to
establish additional licensing, collaboration or similar
arrangements on favorable terms and our ability to attract
collaborators with development, regulatory and commercialization
expertise;
- •
- the success of
competing third-party products or product candidates;
- •
- our ability to
successfully commercialize any approved product candidates,
including their rate and degree of market acceptance;
- •
- our ability to expand
and protect our intellectual property estate;
- •
- regulatory
developments in the United States and other countries;
- •
- the effectiveness of
our internal control over financial reporting;
- •
- the performance of
our third-party suppliers, manufacturers and contract research
organizations and our ability to obtain alternative sources of raw
materials;
- •
- our ability to
attract and retain key personnel; and
- •
- our ability to comply
with regulatory requirements relating to our business, and the
costs of compliance with those requirements, including those on
data privacy and security.
These and other
risks and uncertainties are described in greater detail under the
caption "Risk Factors" in this prospectus, as updated and
supplemented by the discussion of risks and uncertainties under
"Risk Factors" contained in any supplements to this prospectus, or
in the sections entitled "Business," "Risk Factors," "Cautionary
Note Regarding Forward-Looking Statements" or "Management's
Discussion and Analysis of Financial Condition and Results of
Operations" in our most recent annual report on Form 10-K, as
revised or supplemented by our subsequent quarterly reports on
Form 10-Q or our subsequent current reports on Form 8-K,
as well as any amendments thereto, as filed with the SEC and which
are incorporated herein by reference. As a result of the risks and
uncertainties, the results or events indicated by the
forward-looking statements contained in this prospectus or in any
document incorporated herein by reference may not occur.
Investors are
cautioned not to place undue reliance on any forward-looking
statement. Each forward-looking statement represents our views only
as of the date of this prospectus or the date of the document
incorporated by reference in this prospectus and should not be
relied upon as representing our views as of any subsequent date. We
anticipate that subsequent events and developments may cause our
views to change. We expressly disclaim any obligation to update or
alter any forward-looking statement, whether as a result of new
information, future events or otherwise, except as required by law.
Our forward-looking statements do not reflect the potential impact
of any future acquisitions, mergers, dispositions, joint ventures
or investments we may make. All subsequent forward-looking
statements attributable to us or to any person acting on our behalf
are expressly qualified in their entirety by the cautionary
statements contained or referred to in this section.
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USE OF
PROCEEDS
Unless
otherwise indicated in the applicable prospectus supplement, we
intend to use any net proceeds from the sale of securities under
this prospectus for our operations and our further development and
potential commercialization of any or all of our product candidates
odevixibat, elobixibat, and A3384, as well as the development of
other product candidates, and other general corporate purposes,
including, but not limited to, working capital, intellectual
property protection and enforcement, capital expenditures,
repayment of any existing indebtedness, investments, acquisitions
and collaborations. We have not determined the amounts we plan to
spend on any of the areas listed above or the timing of these
expenditures. As a result, our management will have broad
discretion to allocate the net proceeds, if any, we receive in
connection with securities offered pursuant to this prospectus for
any purpose. Pending application of the net proceeds as described
above, we may initially invest the net proceeds in short-term,
investment-grade, interest-bearing securities or apply them to the
reduction of short-term indebtedness.
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PLAN OF
DISTRIBUTION
We may offer
securities under this prospectus from time to time pursuant to
public offerings through one or more placement agents or
underwriters, negotiated transactions, block trades or a
combination of these methods. We may sell the securities
(1) through underwriters or dealers, (2) through agents
or (3) directly to one or more purchasers, or through a
combination of such methods. We may distribute the securities from
time to time in one or more transactions at:
- •
- a fixed price or
prices, which may be changed from time to time;
- •
- market prices
prevailing at the time of sale;
- •
- prices related to the
prevailing market prices; or
- •
- negotiated
prices.
We may directly
solicit offers to purchase the securities being offered by this
prospectus. We may also designate agents to solicit offers to
purchase the securities from time to time, and may enter into
arrangements for "at the market," equity line or similar
transactions. We will name in a prospectus supplement any
underwriter or agent involved in the offer or sale of the
securities.
If we utilize a
dealer in the sale of the securities being offered by this
prospectus, we will sell the securities to the dealer, as
principal. The dealer may then resell the securities to the public
at varying prices to be determined by the dealer at the time of
resale.
If we utilize
an underwriter in the sale of the securities being offered by this
prospectus, we will execute an underwriting agreement with the
underwriter at the time of sale, and we will provide the name of
any underwriter in the prospectus supplement which the underwriter
will use to make resales of the securities to the public. In
connection with the sale of the securities, we, or the purchasers
of the securities for whom the underwriter may act as agent, may
compensate the underwriter in the form of underwriting discounts or
commissions. The underwriter may sell the securities to or through
dealers, and the underwriter may compensate those dealers in the
form of discounts, concessions or commissions.
With respect to
underwritten public offerings, negotiated transactions and block
trades, we will provide in the applicable prospectus supplement
information regarding any compensation we pay to underwriters,
dealers or agents in connection with the offering of the
securities, and any discounts, concessions or commissions allowed
by underwriters to participating dealers. Underwriters, dealers and
agents participating in the distribution of the securities may be
deemed to be underwriters within the meaning of the Securities Act,
and any discounts and commissions received by them and any profit
realized by them on resale of the securities may be deemed to be
underwriting discounts and commissions. We may enter into
agreements to indemnify underwriters, dealers and agents against
civil liabilities, including liabilities under the Securities Act,
or to contribute to payments they may be required to make in
respect thereof.
If so indicated
in the applicable prospectus supplement, we will authorize
underwriters, dealers or other persons acting as our agents to
solicit offers by certain institutions to purchase securities from
us pursuant to delayed delivery contracts providing for payment and
delivery on the date stated in each applicable prospectus
supplement. Each contract will be for an amount not less than, and
the aggregate amount of securities sold pursuant to such contracts
shall not be less nor more than, the respective amounts stated in
each applicable prospectus supplement. Institutions with whom the
contracts, when authorized, may be made include commercial and
savings banks, insurance companies, pension funds, investment
companies, educational and charitable institutions and other
institutions, but shall in all
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cases be subject to
our approval. Delayed delivery contracts will not be subject to any
conditions except that:
- •
- the purchase by an
institution of the securities covered under that contract shall not
at the time of delivery be prohibited under the laws of the
jurisdiction to which that institution is subject; and
- •
- if the securities are
also being sold to underwriters acting as principals for their own
account, the underwriters shall have purchased such securities not
sold for delayed delivery. The underwriters and other persons
acting as our agents will not have any responsibility in respect of
the validity or performance of delayed delivery
contracts.
One or more
firms, referred to as "remarketing firms," may also offer or sell
the securities, if a prospectus supplement so indicates, in
connection with a remarketing arrangement upon their purchase.
Remarketing firms will act as principals for their own accounts or
as our agents. These remarketing firms will offer or sell the
securities in accordance with the terms of the securities. Each
prospectus supplement will identify and describe any remarketing
firm and the terms of its agreement, if any, with us and will
describe the remarketing firm's compensation. Remarketing firms may
be deemed to be underwriters in connection with the securities they
remarket. Remarketing firms may be entitled under agreements that
may be entered into with us to indemnification by us against
certain civil liabilities, including liabilities under the
Securities Act, and may be customers of, engage in transactions
with or perform services for us in the ordinary course of
business.
Certain
underwriters may use this prospectus and any accompanying
prospectus supplement for offers and sales related to market-making
transactions in the securities. These underwriters may act as
principal or agent in these transactions, and the sales will be
made at prices related to prevailing market prices at the time of
sale. Any underwriters involved in the sale of the securities may
qualify as "underwriters" within the meaning of
Section 2(a)(11) of the Securities Act. In addition, the
underwriters' commissions, discounts or concessions may qualify as
underwriters' compensation under the Securities Act and the rules
of the Financial Industry Regulatory Authority, Inc., or
FINRA.
Shares of our
common stock sold pursuant to the registration statement of which
this prospectus is a part will be authorized for listing and
trading on The Nasdaq Capital Market. The applicable prospectus
supplement will contain information, where applicable, as to any
other listing, if any, on The Nasdaq Capital Market or any
securities market or other securities exchange of the securities
covered by the prospectus supplement. Underwriters may make a
market in our common stock, but will not be obligated to do so and
may discontinue any market making at any time without notice. We
can make no assurance as to the liquidity of or the existence,
development or maintenance of trading markets for any of the
securities.
In order to
facilitate the offering of the securities, certain persons
participating in the offering may engage in transactions that
stabilize, maintain or otherwise affect the price of the
securities. This may include over-allotments or short sales of the
securities, which involve the sale by persons participating in the
offering of more securities than we sold to them. In these
circumstances, these persons would cover such over-allotments or
short positions by making purchases in the open market or by
exercising their over-allotment option. In addition, these persons
may stabilize or maintain the price of the securities by bidding
for or purchasing the applicable security in the open market or by
imposing penalty bids, whereby selling concessions allowed to
dealers participating in the offering may be reclaimed if the
securities sold by them are repurchased in connection with
stabilization transactions. The effect of these transactions may be
to stabilize or maintain the market price of the securities at a
level above that which might otherwise prevail in the open market.
These transactions may be discontinued at any time.
The
underwriters, dealers and agents may engage in other transactions
with us, or perform other services for us, in the ordinary course
of their business.
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DESCRIPTION
OF COMMON STOCK
We are
authorized to issue 30,000,000 shares of common stock, par value
$0.01 per share. On March 31, 2020, we had approximately
14,977,855 shares of common stock outstanding and approximately 24
stockholders of record.
The following
summary of certain provisions of our common stock does not purport
to be complete. You should refer to the section of this prospectus
entitled "Certain Provisions of Delaware Law and of the Company's
Certificate of Incorporation and Bylaws" and our restated
certificate of incorporation, as amended, which we refer to as our
restated certificate of incorporation, and our amended and restated
bylaws, which we refer to as our restated bylaws, both of which are
included as exhibits to the registration statement of which this
prospectus is a part. The summary below is also qualified by
provisions of applicable law.
General
Holders of our
common stock are entitled to one vote for each share held on all
matters submitted to a vote of stockholders and do not have
cumulative voting rights. An election of directors by our
stockholders shall be determined by a plurality of the votes cast
by the stockholders entitled to vote on the election. Holders of
common stock are entitled to receive proportionately any dividends
as may be declared by our board of directors, subject to any
preferential dividend rights of any series of preferred stock that
we may designate and issue in the future. All shares of common
stock outstanding as of the date of this prospectus and, upon
issuance and sale, all shares of common stock that we may offer
pursuant to this prospectus, will be fully paid and
nonassessable.
In the event of
our liquidation or dissolution, the holders of common stock are
entitled to receive proportionately our net assets available for
distribution to stockholders after the payment of all debts and
other liabilities and subject to the prior rights of any
outstanding preferred stock. Holders of common stock have no
preemptive, subscription, redemption or conversion rights. There
are no redemption or sinking fund provisions applicable to the
common stock. Our outstanding shares of common stock are validly
issued, fully paid and nonassessable. The rights, preferences and
privileges of holders of common stock are subject to and may be
adversely affected by the rights of the holders of shares of any
series of preferred stock that we may designate and issue in the
future.
Transfer Agent and Registrar
The transfer
agent and registrar for our common stock is Continental Stock
Transfer & Trust Company, with offices at 1 State Street,
30th Floor, New York, NY 10004.
Stock Exchange Listing
Our common
stock is listed for quotation on The Nasdaq Capital Market under
the symbol "ALBO."
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DESCRIPTION
OF PREFERRED STOCK
We are
authorized to issue 50,000,000 shares of preferred stock, par value
$0.01 per share. As of the date of this prospectus, no shares of
our preferred stock were outstanding. The following summary of
certain provisions of our preferred stock does not purport to be
complete. You should refer to our restated certificate of
incorporation and our restated bylaws, both of which are included
as exhibits to the registration statement of which this prospectus
is a part. The summary below is also qualified by provisions of
applicable law.
General
Our board of
directors may, without further action by our stockholders, from
time to time, direct the issuance of shares of preferred stock in
series and may, at the time of issuance, determine the rights,
preferences and limitations of each series, including voting
rights, dividend rights and redemption and liquidation preferences.
Satisfaction of any dividend preferences of outstanding shares of
preferred stock would reduce the amount of funds available for the
payment of dividends on shares of our common stock. Holders of
shares of preferred stock may be entitled to receive a preference
payment in the event of any liquidation, dissolution or winding-up
of our company before any payment is made to the holders of shares
of our common stock. In some circumstances, the issuance of shares
of preferred stock may render more difficult or tend to discourage
a merger, tender offer or proxy contest, the assumption of control
by a holder of a large block of our securities or the removal of
incumbent management. Upon the affirmative vote of our board of
directors, without stockholder approval, we may issue shares of
preferred stock with voting and conversion rights which could
adversely affect the holders of shares of our common
stock.
If we offer a
specific series of preferred stock under this prospectus, we will
describe the terms of the preferred stock in the prospectus
supplement for such offering and will file a copy of the
certificate establishing the terms of the preferred stock with the
SEC. To the extent required, this description will
include:
- •
- the title and stated
value;
- •
- the number of shares
offered, the liquidation preference, if any, per share and the
purchase price;
- •
- the dividend rate(s),
period(s) or payment date(s), or method(s) of calculation for such
dividends;
- •
- whether dividends
will be cumulative or non cumulative and, if cumulative, the date
from which dividends will accumulate;
- •
- the procedures for
any auction and remarketing, if any;
- •
- the provisions for a
sinking fund, if any;
- •
- the provisions for
redemption, if applicable;
- •
- any listing of the
preferred stock on any securities exchange or market;
- •
- whether the preferred
stock will be convertible into our common stock, and, if
applicable, the conversion price (or how it will be calculated) and
conversion period;
- •
- whether the preferred
stock will be exchangeable into debt securities, and, if
applicable, the exchange price (or how it will be calculated) and
exchange period;
- •
- voting rights, if
any, of the preferred stock;
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- •
- a discussion of any
material or special U.S. federal income tax considerations
applicable to the preferred stock;
- •
- the relative ranking
and preferences of the preferred stock as to dividend rights and
rights upon liquidation, dissolution or winding-up of the affairs
of the Company; and
- •
- any material
limitations on issuance of any class or series of preferred stock
ranking pari passu with or senior to the series of preferred stock
as to dividend rights and rights upon liquidation, dissolution or
winding-up of the Company.
Transfer Agent and Registrar
The transfer
agent and registrar for our preferred stock will be set forth in
the applicable prospectus supplement.
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DESCRIPTION
OF DEBT SECURITIES
The following
description, together with the additional information we include in
any applicable prospectus supplements, summarizes the material
terms and provisions of the debt securities that we may offer under
this prospectus. While the terms we have summarized below will
apply generally to any future debt securities we may offer pursuant
to this prospectus, we will describe the particular terms of any
debt securities that we may offer in more detail in the applicable
prospectus supplement. If we so indicate in a prospectus
supplement, the terms of any debt securities offered under such
prospectus supplement may differ from the terms we describe below,
and to the extent the terms set forth in a prospectus supplement
differ from the terms described below, the terms set forth in the
prospectus supplement shall control.
We may sell
from time to time, in one or more offerings under this prospectus,
debt securities, which may be senior or subordinated. We will issue
any such senior debt securities under a senior indenture that we
will enter into with a trustee to be named in the senior indenture.
We will issue any such subordinated debt securities under a
subordinated indenture, which we will enter into with a trustee to
be named in the subordinated indenture. We have filed forms of
these documents as exhibits to the registration statement, of which
this prospectus is a part. We use the term "indentures" to refer to
either the senior indenture or the subordinated indenture, as
applicable. The indentures will be qualified under the Trust
Indenture Act of 1939, or the Trust Indenture Act, as in effect on
the date of the indenture. We use the term "debenture trustee" to
refer to either the trustee under the senior indenture or the
trustee under the subordinated indenture, as applicable.
The following
summaries of material provisions of the senior debt securities, the
subordinated debt securities and the indentures are subject to, and
qualified in their entirety by reference to, all the provisions of
the indenture applicable to a particular series of debt
securities.
General
Each indenture
provides that debt securities may be issued from time to time in
one or more series and may be denominated and payable in foreign
currencies or units based on or relating to foreign currencies.
Neither the senior indenture nor any subordinated indenture limits
the amount of debt securities that may be issued thereunder, and
each indenture provides that the specific terms of any series of
debt securities shall be set forth in, or determined pursuant to,
an authorizing resolution or a supplemental indenture, if any,
relating to such series.
We will
describe in each prospectus supplement the following terms relating
to a series of debt securities:
- •
- the title or
designation;
- •
- the aggregate
principal amount and any limit on the amount that may be
issued;
- •
- the currency or units
based on or relating to currencies in which debt securities of such
series are denominated and the currency or units in which principal
or interest or both will or may be payable;
- •
- whether we will issue
the series of debt securities in global form, the terms of any
global securities and who the depositary will be;
- •
- the maturity date and
the date or dates on which principal will be payable;
- •
- the interest rate,
which may be fixed or variable, or the method for determining the
rate and the date interest will begin to accrue, the date or dates
interest will be payable and the record dates for interest payment
dates or the method for determining such dates;
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- •
- whether or not the
debt securities will be secured or unsecured, and the terms of any
secured debt;
- •
- the terms of the
subordination of any series of subordinated debt;
- •
- the place or places
where payments will be payable;
- •
- our right, if any, to
defer payment of interest and the maximum length of any such
deferral period;
- •
- the date, if any,
after which, and the price at which, we may, at our option, redeem
the series of debt securities pursuant to any optional redemption
provisions;
- •
- the date, if any, on
which, and the price at which we are obligated, pursuant to any
mandatory sinking fund provisions or otherwise, to redeem, or at
the holder's option to purchase, the series of debt
securities;
- •
- whether the indenture
will restrict our ability to pay dividends, or will require us to
maintain any asset ratios or reserves;
- •
- whether we will be
restricted from incurring any additional indebtedness;
- •
- a discussion of any
material or special U.S. federal income tax considerations
applicable to a series of debt securities;
- •
- the denominations in
which we will issue the series of debt securities, if other than
denominations of $1,000 and any integral multiple thereof;
and
- •
- any other specific
terms, preferences, rights or limitations of, or restrictions on,
the debt securities.
We may issue
debt securities that provide for an amount less than their stated
principal amount to be due and payable upon declaration of
acceleration of their maturity pursuant to the terms of the
indenture. We will provide you with information on the federal
income tax considerations and other special considerations
applicable to any of these debt securities in the applicable
prospectus supplement.
Conversion or Exchange Rights
We will set
forth in the prospectus supplement the terms, if any, on which a
series of debt securities may be convertible into or exchangeable
for our common stock or our other securities. We will include
provisions as to whether conversion or exchange is mandatory, at
the option of the holder or at our option. We may include
provisions pursuant to which the number of shares of our common
stock or our other securities that the holders of the series of
debt securities receive would be subject to adjustment.
Consolidation, Merger or Sale; No Protection in Event of a Change
of Control or Highly Leveraged Transaction
The indentures
do not contain any covenant that restricts our ability to merge or
consolidate, or sell, convey, transfer or otherwise dispose of all
or substantially all of our assets. However, any successor to or
acquirer of such assets must assume all of our obligations under
the indentures or the debt securities, as appropriate.
Unless we state
otherwise in the applicable prospectus supplement, the debt
securities will not contain any provisions that may afford holders
of the debt securities protection in the event we have a change of
control or in the event of a highly leveraged transaction (whether
or not such transaction results in a change of control), which
could adversely affect holders of debt securities.
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Events of Default Under the Indenture
The following
are events of default under the indentures with respect to any
series of debt securities that we may issue:
- •
- if we fail to pay
interest when due and our failure continues for 90 days and
the time for payment has not been extended or deferred;
- •
- if we fail to pay the
principal, or premium, if any, when due and the time for payment
has not been extended or delayed;
- •
- if we fail to observe
or perform any other covenant set forth in the debt securities of
such series or the applicable indentures, other than a covenant
specifically relating to and for the benefit of holders of another
series of debt securities, and our failure continues for
90 days after we receive written notice from the debenture
trustee or holders of not less than a majority in aggregate
principal amount of the outstanding debt securities of the
applicable series; and
- •
- if specified events
of bankruptcy, insolvency or reorganization occur as to
us.
No event of
default with respect to a particular series of debt securities
(except as to certain events of bankruptcy, insolvency or
reorganization) necessarily constitutes an event of default with
respect to any other series of debt securities. The occurrence of
an event of default may constitute an event of default under any
bank credit agreements we may have in existence from time to time.
In addition, the occurrence of certain events of default or an
acceleration under the indenture may constitute an event of default
under certain of our other indebtedness outstanding from time to
time.
If an event of
default with respect to debt securities of any series at the time
outstanding occurs and is continuing, then the trustee or the
holders of not less than a majority in principal amount of the
outstanding debt securities of that series may, by a notice in
writing to us (and to the debenture trustee if given by the
holders), declare to be due and payable immediately the principal
(or, if the debt securities of that series are discount securities,
that portion of the principal amount as may be specified in the
terms of that series) of and premium and accrued and unpaid
interest, if any, on all debt securities of that series. Before a
judgment or decree for payment of the money due has been obtained
with respect to debt securities of any series, the holders of a
majority in principal amount of the outstanding debt securities of
that series (or, at a meeting of holders of such series at which a
quorum is present, the holders of a majority in principal amount of
the debt securities of such series represented at such meeting) may
rescind and annul the acceleration if all events of default, other
than the non-payment of accelerated principal, premium, if any, and
interest, if any, with respect to debt securities of that series,
have been cured or waived as provided in the applicable indenture
(including payments or deposits in respect of principal, premium or
interest that had become due other than as a result of such
acceleration). We refer you to the prospectus supplement relating
to any series of debt securities that are discount securities for
the particular provisions relating to acceleration of a portion of
the principal amount of such discount securities upon the
occurrence of an event of default.
Subject to the
terms of the indentures, if an event of default under an indenture
shall occur and be continuing, the debenture trustee will be under
no obligation to exercise any of its rights or powers under such
indenture at the request or direction of any of the holders of the
applicable series of debt securities, unless such holders have
offered the debenture trustee reasonable indemnity. The holders of
a majority in principal amount of the outstanding debt securities
of any series will have the right to direct the time, method and
place of conducting any proceeding for any remedy available to the
debenture trustee, or exercising any trust or power conferred on
the debenture trustee, with respect to the debt securities of that
series, provided that:
- •
- the direction so
given by the holder is not in conflict with any law or the
applicable indenture; and
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- •
- subject to its duties
under the Trust Indenture Act, the debenture trustee need not take
any action that might involve it in personal liability or might be
unduly prejudicial to the holders not involved in the
proceeding.
A holder of the
debt securities of any series will only have the right to institute
a proceeding under the indentures or to appoint a receiver or
trustee, or to seek other remedies if:
- •
- the holder previously
has given written notice to the debenture trustee of a continuing
event of default with respect to that series;
- •
- the holders of at
least a majority in aggregate principal amount of the outstanding
debt securities of that series have made written request, and such
holders have offered reasonable indemnity to the debenture trustee
to institute the proceeding as trustee; and
- •
- the debenture trustee
does not institute the proceeding, and does not receive from the
holders of a majority in aggregate principal amount of the
outstanding debt securities of that series (or at a meeting of
holders of such series at which a quorum is present, the holders of
a majority in principal amount of the debt securities of such
series represented at such meeting) other conflicting directions
within 60 days after the notice, request and
offer.
These
limitations do not apply to a suit instituted by a holder of debt
securities if we default in the payment of the principal, premium,
if any, or interest on, the debt securities.
We will
periodically file statements with the applicable debenture trustee
regarding our compliance with specified covenants in the applicable
indenture.
Modification of Indenture; Waiver
The debenture
trustee and we may change the applicable indenture without the
consent of any holders with respect to specific matters,
including:
- •
- to fix any ambiguity,
defect or inconsistency in the indenture; and
- •
- to change anything
that does not materially adversely affect the interests of any
holder of debt securities of any series issued pursuant to such
indenture.
In addition,
under the indentures, the rights of holders of a series of debt
securities may be changed by us and the debenture trustee with the
written consent of the holders of at least a majority in aggregate
principal amount of the outstanding debt securities of each series
(or, at a meeting of holders of such series at which a quorum is
present, the holders of a majority in principal amount of the debt
securities of such series represented at such meeting) that is
affected. However, the debenture trustee and we may make the
following changes only with the consent of each holder of any
outstanding debt securities affected:
- •
- extending the fixed
maturity of the series of debt securities;
- •
- reducing the
principal amount, reducing the rate of or extending the time of
payment of interest, or any premium payable upon the redemption of
any debt securities;
- •
- reducing the
principal amount of discount securities payable upon acceleration
of maturity;
- •
- making the principal
of or premium or interest on any debt security payable in currency
other than that stated in the debt security; or
- •
- reducing the
percentage of debt securities, the holders of which are required to
consent to any amendment or waiver.
Except for
certain specified provisions, the holders of at least a majority in
principal amount of the outstanding debt securities of any series
(or, at a meeting of holders of such series at which a
quorum
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is present, the
holders of a majority in principal amount of the debt securities of
such series represented at such meeting) may on behalf of the
holders of all debt securities of that series waive our compliance
with provisions of the indenture. The holders of a majority in
principal amount of the outstanding debt securities of any series
may on behalf of the holders of all the debt securities of such
series waive any past default under the indenture with respect to
that series and its consequences, except a default in the payment
of the principal of, premium or any interest on any debt security
of that series or in respect of a covenant or provision, which
cannot be modified or amended without the consent of the holder of
each outstanding debt security of the series affected; provided,
however, that the holders of a majority in principal amount of the
outstanding debt securities of any series may rescind an
acceleration and its consequences, including any related payment
default that resulted from the acceleration.
Discharge
Each indenture
provides that we can elect to be discharged from our obligations
with respect to one or more series of debt securities, except for
obligations to:
- •
- transfer or exchange
debt securities of the series;
- •
- replace stolen, lost
or mutilated debt securities of the series;
- •
- maintain paying
agencies;
- •
- hold monies for
payment in trust;
- •
- compensate and
indemnify the trustee; and
- •
- appoint any successor
trustee.
In order to
exercise our rights to be discharged with respect to a series, we
must deposit with the trustee money or government obligations
sufficient to pay all the principal of, the premium, if any, and
interest on, the debt securities of the series on the dates
payments are due.
Form, Exchange, and Transfer
We will issue
the debt securities of each series only in fully registered form
without coupons and, unless we otherwise specify in the applicable
prospectus supplement, in denominations of $1,000 and any integral
multiple thereof. The indentures provide that we may issue debt
securities of a series in temporary or permanent global form and as
book-entry securities that will be deposited with, or on behalf of,
The Depository Trust Company or another depositary named by us and
identified in a prospectus supplement with respect to that
series.
At the option
of the holder, subject to the terms of the indentures and the
limitations applicable to global securities described in the
applicable prospectus supplement, the holder of the debt securities
of any series can exchange the debt securities for other debt
securities of the same series, in any authorized denomination and
of like tenor and aggregate principal amount.
Subject to the
terms of the indentures and the limitations applicable to global
securities set forth in the applicable prospectus supplement,
holders of the debt securities may present the debt securities for
exchange or for registration of transfer, duly endorsed or with the
form of transfer endorsed thereon duly executed if so required by
us or the security registrar, at the office of the security
registrar or at the office of any transfer agent designated by us
for this purpose. Unless otherwise provided in the debt securities
that the holder presents for transfer or exchange or in the
applicable indenture, we will make no service charge for any
registration of transfer or exchange, but we may require payment of
any taxes or other governmental charges.
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We will name in
the applicable prospectus supplement the security registrar, and
any transfer agent in addition to the security registrar, that we
initially designate for any debt securities. We may at any time
designate additional transfer agents or rescind the designation of
any transfer agent or approve a change in the office through which
any transfer agent acts, except that we will be required to
maintain a transfer agent in each place of payment for the debt
securities of each series.
If we elect to
redeem the debt securities of any series, we will not be required
to:
- •
- issue, register the
transfer of, or exchange any debt securities of that series during
a period beginning at the opening of business 15 days before
the day of mailing of a notice of redemption of any debt securities
that may be selected for redemption and ending at the close of
business on the day of the mailing; or
- •
- register the transfer
of or exchange any debt securities so selected for redemption, in
whole or in part, except the unredeemed portion of any debt
securities we are redeeming in part.
Information Concerning the Debenture Trustee
The debenture
trustee, other than during the occurrence and continuance of an
event of default under the applicable indenture, undertakes to
perform only those duties as are specifically set forth in the
applicable indenture. Upon an event of default under an indenture,
the debenture trustee under such indenture must use the same degree
of care as a prudent person would exercise or use in the conduct of
his or her own affairs. Subject to this provision, the debenture
trustee is under no obligation to exercise any of the powers given
it by the indentures at the request of any holder of debt
securities unless it is offered reasonable security and indemnity
against the costs, expenses and liabilities that it might
incur.
Payment and Paying Agents
Unless we
otherwise indicate in the applicable prospectus supplement, we will
make payment of the interest on any debt securities on any interest
payment date to the person in whose name the debt securities, or
one or more predecessor securities, are registered at the close of
business on the regular record date for the interest.
We will pay
principal of and any premium and interest on the debt securities of
a particular series at the office of the paying agents designated
by us, except that, unless we otherwise indicate in the applicable
prospectus supplement, we will make interest payments by check
which we will mail to the holder. Unless we otherwise indicate in a
prospectus supplement, we will designate the corporate trust office
of the debenture trustee in the City of New York as our sole paying
agent for payments with respect to debt securities of each series.
We will name in the applicable prospectus supplement any other
paying agents that we initially designate for the debt securities
of a particular series. We will maintain a paying agent in each
place of payment for the debt securities of a particular
series.
All money we
pay to a paying agent or the debenture trustee for the payment of
the principal of or any premium or interest on any debt securities
which remains unclaimed at the end of two years after such
principal, premium or interest has become due and payable will be
repaid to us, and the holder of the security thereafter may look
only to us for payment thereof.
Governing Law
The indentures
and the debt securities will be governed by and construed in
accordance with the laws of the State of New York, except to the
extent that the Trust Indenture Act is applicable.
Subordination of Subordinated Debt Securities
Our obligations
pursuant to any subordinated debt securities will be unsecured and
will be subordinate and junior in priority of payment to certain of
our other indebtedness to the extent described in a prospectus
supplement. The subordinated indenture does not limit the amount of
senior indebtedness we may incur. It also does not limit us from
issuing any other secured or unsecured debt.
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DESCRIPTION
OF WARRANTS
General
We may issue
warrants to purchase shares of our common stock, preferred stock or
debt securities in one or more series together with other
securities or separately, as described in the applicable prospectus
supplement. Below is a description of certain general terms and
provisions of the warrants that we may offer. Particular terms of
the warrants will be described in the warrant agreements and the
prospectus supplement relating to the warrants.
The applicable
prospectus supplement will contain, where applicable, the following
terms of and other information relating to the warrants:
- •
- the specific
designation and aggregate number of, and the price at which we will
issue, the warrants;
- •
- the currency or
currency units in which the offering price, if any, and the
exercise price are payable;
- •
- the designation,
amount and terms of the securities purchasable upon exercise of the
warrants;
- •
- if applicable, the
exercise price for shares of our common stock and the number of
shares of common stock to be received upon exercise of the
warrants;
- •
- if applicable, the
exercise price for shares of our preferred stock, the number of
shares of preferred stock to be received upon exercise, and a
description of that series of our preferred stock;
- •
- if applicable, the
exercise price for our debt securities, the amount of debt
securities to be received upon exercise, and a description of that
series of debt securities;
- •
- the date on which the
right to exercise the warrants will begin and the date on which
that right will expire or, if you may not continuously exercise the
warrants throughout that period, the specific date or dates on
which you may exercise the warrants;
- •
- whether the warrants
will be issued in fully registered form or bearer form, in
definitive or global form or in any combination of these forms,
although, in any case, the form of a warrant included in a unit
will correspond to the form of the unit and of any security
included in that unit;
- •
- any applicable
material U.S. federal income tax consequences;
- •
- the identity of the
warrant agent for the warrants and of any other depositaries,
execution or paying agents, transfer agents, registrars or other
agents;
- •
- the proposed listing,
if any, of the warrants or any securities purchasable upon exercise
of the warrants on any securities exchange;
- •
- if applicable, the
date from and after which the warrants and the common stock,
preferred stock or debt securities will be separately
transferable;
- •
- if applicable, the
minimum or maximum amount of the warrants that may be exercised at
any one time;
- •
- information with
respect to book-entry procedures, if any;
- •
- the anti-dilution
provisions of the warrants, if any;
- •
- any redemption or
call provisions;
- •
- whether the warrants
may be sold separately or with other securities as parts of units;
and
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- •
- any additional terms
of the warrants, including terms, procedures and limitations
relating to the exchange and exercise of the warrants.
Outstanding Warrants
As of
March 31, 2020, we had no warrants outstanding.
Transfer Agent and Registrar
The transfer
agent and registrar for any warrants will be set forth in the
applicable prospectus supplement.
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DESCRIPTION
OF RIGHTS
General
We may issue
rights to our stockholders to purchase shares of our common stock,
preferred stock or the other securities described in this
prospectus. We may offer rights separately or together with one or
more additional rights, debt securities, preferred stock, common
stock or warrants, or any combination of those securities in the
form of units, as described in the applicable prospectus
supplement. Each series of rights will be issued under a separate
rights agreement to be entered into between us and a bank or trust
company, as rights agent. The rights agent will act solely as our
agent in connection with the certificates relating to the rights of
the series of certificates and will not assume any obligation or
relationship of agency or trust for or with any holders of rights
certificates or beneficial owners of rights. The following
description sets forth certain general terms and provisions of the
rights to which any prospectus supplement may relate. The
particular terms of the rights to which any prospectus supplement
may relate and the extent, if any, to which the general provisions
may apply to the rights so offered will be described in the
applicable prospectus supplement. To the extent that any particular
terms of the rights, rights agreement or rights certificates
described in a prospectus supplement differ from any of the terms
described below, then the terms described below will be deemed to
have been superseded by that prospectus supplement. We encourage
you to read the applicable rights agreement and rights certificate
for additional information before you decide whether to purchase
any of our rights.
We will provide
in a prospectus supplement the following terms of the rights being
issued:
- •
- the date of
determining the stockholders entitled to the rights
distribution;
- •
- the aggregate number
of shares of common stock, preferred stock or other securities
purchasable upon exercise of the rights;
- •
- the exercise
price;
- •
- the aggregate number
of rights issued;
- •
- whether the rights
are transferrable and the date, if any, on and after which the
rights may be separately transferred;
- •
- the date on which the
right to exercise the rights will commence, and the date on which
the right to exercise the rights will expire;
- •
- the method by which
holders of rights will be entitled to exercise;
- •
- the conditions to the
completion of the offering, if any;
- •
- the withdrawal,
termination and cancellation rights, if any;
- •
- whether there are any
backstop or standby purchaser or purchasers and the terms of their
commitment, if any;
- •
- whether stockholders
are entitled to oversubscription rights, if any;
- •
- any applicable
material U.S. federal income tax considerations; and
- •
- any other terms of
the rights, including terms, procedures and limitations relating to
the distribution, exchange and exercise of the rights, as
applicable.
Each right will
entitle the holder of rights to purchase for cash the principal
amount of shares of common stock, preferred stock or other
securities at the exercise price provided in the applicable
prospectus supplement. Rights may be exercised at any time up to
the close of business on the expiration date for the rights
provided in the applicable prospectus supplement.
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Holders may
exercise rights as described in the applicable prospectus
supplement. Upon receipt of payment and the rights certificate
properly completed and duly executed at the corporate trust office
of the rights agent or any other office indicated in the prospectus
supplement, we will, as soon as practicable, forward the shares of
common stock, preferred stock or other securities, as applicable,
purchasable upon exercise of the rights. If less than all of the
rights issued in any rights offering are exercised, we may offer
any unsubscribed securities directly to persons other than
stockholders, to or through agents, underwriters or dealers or
through a combination of such methods, including pursuant to
standby arrangements, as described in the applicable prospectus
supplement.
Rights Agent
The rights
agent for any rights we offer will be set forth in the applicable
prospectus supplement.
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DESCRIPTION
OF UNITS
The following
description, together with the additional information that we
include in any applicable prospectus supplements summarizes the
material terms and provisions of the units that we may offer under
this prospectus. While the terms we have summarized below will
apply generally to any units that we may offer under this
prospectus, we will describe the particular terms of any series of
units in more detail in the applicable prospectus supplement. The
terms of any units offered under a prospectus supplement may differ
from the terms described below.
We will
incorporate by reference from reports that we file with the SEC,
the form of unit agreement that describes the terms of the series
of units we are offering, and any supplemental agreements, before
the issuance of the related series of units. The following
summaries of material terms and provisions of the units are subject
to, and qualified in their entirety by reference to, all the
provisions of the unit agreement and any supplemental agreements
applicable to a particular series of units. We urge you to read the
applicable prospectus supplements related to the particular series
of units that we may offer under this prospectus, as well as any
related free writing prospectuses and the complete unit agreement
and any supplemental agreements that contain the terms of the
units.
General
We may issue
units consisting of common stock, preferred stock, one or more debt
securities, warrants or rights for the purchase of common stock,
preferred stock or debt securities in one or more series, in any
combination. Each unit will be issued so that the holder of the
unit is also the holder of each security included in the unit.
Thus, the holder of a unit will have the rights and obligations of
a holder of each security included in the unit. The unit agreement
under which a unit is issued may provide that the securities
included in the unit may not be held or transferred separately, at
any time or at any time before a specified date.
We will
describe in the applicable prospectus supplement the terms of the
series of units being offered, including:
- •
- the designation and
terms of the units and of the securities comprising the units,
including whether and under what circumstances those securities may
be held or transferred separately;
- •
- any provisions of the
governing unit agreement that differ from those described below;
and
- •
- any provisions for
the issuance, payment, settlement, transfer or exchange of the
units or of the securities comprising the units.
The provisions
described in this section, as well as those set forth in any
prospectus supplement or as described under "Description of Common
Stock," "Description of Preferred Stock," "Description of Debt
Securities," "Description of Warrants," and "Description of Rights"
will apply to each unit, as applicable, and to any common stock,
preferred stock, debt security, warrant or right included in each
unit, as applicable.
Unit Agent
The name and
address of the unit agent for any units we offer will be set forth
in the applicable prospectus supplement.
Issuance in Series
We may issue
units in such amounts and in such numerous distinct series as we
determine.
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Enforceability of Rights by Holders of Units
Each unit agent
will act solely as our agent under the applicable unit agreement
and will not assume any obligation or relationship of agency or
trust with any holder of any unit. A single bank or trust company
may act as unit agent for more than one series of units. A unit
agent will have no duty or responsibility in case of any default by
us under the applicable unit agreement or unit, including any duty
or responsibility to initiate any proceedings at law or otherwise,
or to make any demand upon us. Any holder of a unit may, without
the consent of the related unit agent or the holder of any other
unit, enforce by appropriate legal action its rights as holder
under any security included in the unit.
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CERTAIN
PROVISIONS OF DELAWARE LAW AND OF THE COMPANY'S CERTIFICATE OF
INCORPORATION AND BYLAWS
Anti-Takeover Provisions
The provisions
of Delaware law and our restated certificate of incorporation and
restated bylaws could discourage or make it more difficult to
accomplish a proxy contest or other change in our management or the
acquisition of control by a holder of a substantial amount of our
voting stock. It is possible that these provisions could make it
more difficult to accomplish, or could deter, transactions that
stockholders may otherwise consider to be in their best interests
or in our best interests. These provisions are intended to enhance
the likelihood of continuity and stability in the composition of
our board of directors and in the policies formulated by the board
of directors and to discourage certain types of transactions that
may involve an actual or threatened change of our control. These
provisions are designed to reduce our vulnerability to an
unsolicited acquisition proposal and to discourage certain tactics
that may be used in proxy fights. Such provisions also may have the
effect of preventing changes in our management.
Delaware Statutory Business Combinations Provision
We are subject
to the anti-takeover provisions of Section 203 of the Delaware
General Corporation Law. Section 203 prohibits a publicly-held
Delaware corporation from engaging in a "business combination" with
an "interested stockholder" for a period of three years after the
date of the transaction in which the person became an interested
stockholder, unless the business combination is, or the transaction
in which the person became an interested stockholder was, approved
in a prescribed manner or another prescribed exception applies. For
purposes of Section 203, a "business combination" is defined
broadly to include a merger, asset sale or other transaction
resulting in a financial benefit to the interested stockholder,
and, subject to certain exceptions, an "interested stockholder" is
a person who, together with his or her affiliates and associates,
owns, or within three years prior, did own, 15% or more of the
corporation's voting stock.
Classified Board of Directors; Removal of Directors for
Cause
Pursuant to our
restated certificate of incorporation and restated bylaws, our
board of directors is divided into three classes, with the term of
office of each class to expire at the third annual meeting of
stockholders following election. At each annual meeting of
stockholders, directors elected to succeed those directors whose
terms expire, other than directors elected by the holders of any
series of preferred stock under specified circumstances, will be
elected for a three-year term of office. All directors elected to
our classified board of directors will serve until the election and
qualification of their respective successors or their earlier
death, resignation or removal. Members of the board of directors
may be removed only for cause and only by the affirmative vote of
the holders of at least a majority of the voting power of our then
outstanding shares of capital stock entitled to vote generally in
the election of directors, voting together as a single class. These
provisions are likely to increase the time required for
stockholders to change the composition of the board of directors.
For example, at least two annual meetings will be necessary for
stockholders to effect a change in a majority of the members of the
board of directors.
Advance Notice Provisions for Stockholder Proposals and Stockholder
Nominations of Directors
Our restated
bylaws provide that, for nominations to the board of directors or
for other business to be properly brought by a stockholder before a
meeting of stockholders, the stockholder must first have given
timely notice of the proposal in writing to our Secretary. For an
annual meeting, a stockholder's notice generally must be delivered
not less than 90 days nor more than 120 days prior to the
first anniversary of the previous year's annual meeting date. For a
special meeting, the notice must
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generally be delivered
not earlier than the 120th day prior to the meeting and not
later than the later of (1) the 90th day prior to the
meeting or (2) the 10th day following the day on which
public announcement of the meeting is first made. Detailed
requirements as to the form of the notice and information required
in the notice are specified in the restated bylaws. If it is
determined that business was not properly brought before a meeting
in accordance with our bylaw provisions, such business will not be
conducted at the meeting.
Special Meetings of Stockholders
Special
meetings of the stockholders may be called only by the chairman of
our board of directors, our Chief Executive Officer, our President
or our board of directors pursuant to a resolution adopted by a
majority of our board of directors.
No Stockholder Action by Written Consent
Any action to
be effected by our stockholders must be effected at a duly called
annual or special meeting of the stockholders.
Super Majority Stockholder Vote Required for Certain
Actions
The Delaware
General Corporation Law provides generally that the affirmative
vote of a majority of the shares entitled to vote on any matter is
required to amend a corporation's certificate of incorporation or
bylaws, unless the corporation's certificate of incorporation or
bylaws, as the case may be, require a greater percentage. Our
restated certificate of incorporation requires the affirmative vote
of the holders of at least 75% of the voting power of all of our
outstanding shares of capital stock entitled to vote generally in
the election of directors, voting together as a single class, to
amend or repeal any of the provisions discussed in this section of
this prospectus. This 75% stockholder vote would be in addition to
any separate class vote that might in the future be required
pursuant to the terms of any preferred stock that might then be
outstanding. A 75% vote is also required for any amendment to, or
repeal of, our restated bylaws by the stockholders. Our restated
bylaws may be amended or repealed by vote of a majority of the
authorized number of directors.
Limitation of Liability and Indemnification
Our restated
certificate of incorporation and our restated bylaws provide that
we shall indemnify our directors and executive officers to the
fullest extent not prohibited by the Delaware General Corporation
Law or any other applicable law, except that we are not required to
indemnify any director or executive officer in connection with any
proceeding (or part thereof) initiated by such person unless
(i) such indemnification is expressly required to be made by
law, (ii) the proceeding was authorized by our board of
directors, (iii) we provide such indemnification, in our sole
discretion, pursuant to the powers vested in us under the Delaware
General Corporation Law or any other applicable law, or
(iv) such indemnification is required to be made under the
enforcement provisions of our restated bylaws.
Section 145
of the Delaware General Corporation Law permits a corporation to
indemnify any director or officer of the corporation against
expenses (including attorneys' fees), judgments, fines and amounts
paid in settlement actually and reasonably incurred in connection
with any action, suit or proceeding brought by reason of the fact
that such person is or was a director or officer of the
corporation, if such person acted in good faith and in a manner
that he or she reasonably believed to be in, or not opposed to, the
best interests of the corporation, and, with respect to any
criminal action or proceeding, if he or she had no reasonable cause
to believe his or her conduct was unlawful. In a derivative action
(i.e., one brought by or on behalf of the corporation),
indemnification may be provided only for expenses actually and
reasonably incurred by any director or officer in
connection
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with the defense or
settlement of such an action or suit if such person acted in good
faith and in a manner that he or she reasonably believed to be in,
or not opposed to, the best interests of the corporation, except
that no indemnification shall be provided if such person shall have
been adjudged to be liable to the corporation, unless and only to
the extent that the Delaware Chancery Court or the court in which
the action or suit was brought shall determine that such person is
fairly and reasonably entitled to indemnity for such expenses
despite such adjudication of liability.
Pursuant to
Section 102(b)(7) of the Delaware General Corporation Law,
Article Sixth of our restated certificate of incorporation
eliminates the liability of a director to us or our stockholders
for monetary damages for such a breach of fiduciary duty as a
director to the fullest extent under applicable law, which does not
include liabilities arising:
- •
- from any breach of
the director's duty of loyalty to us or our stockholders;
- •
- from acts or
omissions not in good faith or which involve intentional misconduct
or a knowing violation of law;
- •
- under
Section 174 of the Delaware General Corporation Law;
and
- •
- from any transaction
from which the director derived an improper personal
benefit.
We have entered
into indemnification agreements with our directors and executive
officers, in addition to the indemnification provided in our
restated certificate of incorporation and our restated bylaws, and
intend to enter into indemnification agreements with any new
directors and executive officers in the future. We have purchased
and intend to maintain insurance on behalf of any person who is or
was a director or officer against any loss arising from any claim
asserted against him or her and incurred by him or her in any such
capacity, subject to certain exclusions.
The foregoing
discussion of our restated certificate of incorporation, restated
bylaws, indemnification agreements and Delaware law is not intended
to be exhaustive and is qualified in its entirety by such restated
certificate of incorporation, restated bylaws, indemnification
agreements or law.
Insofar as
indemnification for liabilities arising under the Securities Act
may be permitted to our directors, officers and controlling persons
pursuant to the foregoing provisions, or otherwise, we have been
advised that in the opinion of the SEC such indemnification is
against public policy as expressed in the Securities Act and is,
therefore, unenforceable.
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LEGAL
MATTERS
Mintz, Levin,
Cohn, Ferris, Glovsky and Popeo, P.C., Boston, Massachusetts, will
pass upon the validity of the issuance of the securities to be
offered by this prospectus.
EXPERTS
The
consolidated financial statements of Albireo Pharma, Inc.
appearing in Albireo Pharma, Inc.'s
Annual Report (Form 10-K) for the year ended December 31,
2019, and the effectiveness of Albireo Pharma, Inc.'s
internal control over financial reporting as of December 31,
2019, have been audited by Ernst & Young LLP,
independent registered public accounting firm, as set forth in its
reports thereon, which are included therein and incorporated herein
by reference. Such financial statements have been incorporated
herein by reference in reliance upon such reports given on the
authority of such firm as experts in accounting and
auditing.
WHERE YOU
CAN FIND MORE INFORMATION
We are subject
to the reporting requirements of the Exchange Act and file annual,
quarterly and current reports, proxy statements and other
information with the SEC. SEC filings are available at the SEC's
web site at http://www.sec.gov.
This prospectus
is only part of a registration statement on Form S-3 that we
have filed with the SEC under the Securities Act, and therefore
omits certain information contained in the registration statement.
We have also filed exhibits and schedules with the registration
statement that are excluded from this prospectus, and you should
refer to the applicable exhibit or schedule for a complete
description of any statement referring to any contract or other
document. We also maintain a website at www.albireopharma.com,
through which you can access our SEC filings. The information set
forth on our website is not part of this prospectus.
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INCORPORATION OF DOCUMENTS BY
REFERENCE
The SEC allows
us to "incorporate by reference" information that we file with
them. Incorporation by reference allows us to disclose important
information to you by referring you to those other documents. The
information incorporated by reference is an important part of this
prospectus, and information that we file later with the SEC will
automatically update and supersede this information. We filed a
registration statement on Form S-3 under the Securities Act
with the SEC with respect to the securities we may offer pursuant
to this prospectus. This prospectus omits certain information
contained in the registration statement, as permitted by the SEC.
You should refer to the registration statement, including the
exhibits, for further information about us and the securities we
may offer pursuant to this prospectus. Statements in this
prospectus regarding the provisions of certain documents filed
with, or incorporated by reference in, the registration statement
are not necessarily complete and each statement is qualified in all
respects by that reference. Copies of all or any part of the
registration statement, including the documents incorporated by
reference or the exhibits, are available at the SEC's web site at
http://www.sec.gov. The documents we are incorporating by reference
are:
- •
-
our Annual Report on Form 10-K for the fiscal year ended
December 31, 2019 that we filed with the SEC on March 2,
2020;
- •
-
the portions of our definitive proxy statement on Schedule 14A
that we filed with the SEC on April 17, 2020 that are deemed
"filed" with the SEC under the Exchange Act;
- •
-
our Quarterly Report on Form 10-Q for the quarter ended
March 31, 2020 that we filed with the SEC on May 7,
2020;
- •
- our Current Reports
on Form 8-K that we filed with the SEC on
January 29, 2020,
January 29, 2020,
January 30, 2020,
February 3, 2020 and
March 26, 2020 (except for the information furnished under
Items 2.02 or 7.01 and the exhibits furnished thereto);
- •
-
the description of our common stock contained in our Registration
Statement on Form 8-A filed with the SEC on May 8, 2007,
including any amendment or report filed for the purpose of updating
such description; and
- •
- all reports and other
documents subsequently filed by us pursuant to Sections 13(a),
13(c), 14 and 15(d) of the Exchange Act after the date of this
prospectus and prior to the termination or completion of the
offering of securities under this prospectus shall be deemed to be
incorporated by reference in this prospectus and to be a part
hereof from the date of filing such reports and other
documents.
The SEC file
number for each of the documents listed above is
001-33451.
In addition,
all reports and other documents filed by us pursuant to the
Exchange Act after the date of the initial registration statement
and prior to effectiveness of the registration statement shall be
deemed to be incorporated by reference into this
prospectus.
Any statement
contained in this prospectus or in a document incorporated or
deemed to be incorporated by reference into this prospectus will be
deemed to be modified or superseded for purposes of this prospectus
to the extent that a statement contained in this prospectus or any
other subsequently filed document that is deemed to be incorporated
by reference into this prospectus modifies or supersedes the
statement. Any statement so modified or superseded will not be
deemed, except as so modified or superseded, to constitute a part
of this prospectus.
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You may
request, orally or in writing, a copy of any or all of the
documents incorporated herein by reference. These documents will be
provided to you at no cost, by contacting:
Albireo
Pharma, Inc.
10 Post Office Square, Suite 1000
Boston, Massachusetts 02109
(857) 254-5555
You may also
access these documents on our website,
http://www.albireopharma.com. The information contained on, or that
can be accessed through, our website is not a part of this
prospectus. We have included our website address in this prospectus
solely as an inactive textual reference.
You should rely
only on information contained in, or incorporated by reference
into, this prospectus and any prospectus supplement. We have not
authorized anyone to provide you with information different from
that contained in this prospectus or incorporated by reference in
this prospectus. We are not making offers to sell the securities in
any jurisdiction in which such an offer or solicitation is not
authorized or in which the person making such offer or solicitation
is not qualified to do so or to anyone to whom it is unlawful to
make such offer or solicitation.
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4,000,000 Shares

Common Stock
PROSPECTUS SUPPLEMENT
|
|
|
Joint Bookrunning Managers |
Cowen |
|
William Blair |
|
|
|
|
|
Co-Managers |
Wedbush PacGrow |
|
H.C. Wainwright & Co. |
|
Baird |
September 9, 2020
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