# EDGAR Filing Document

**Accession Number:** 0001370483
**File Stem:** 0001193125-23-005142
**Filing Date:** 2023-1
**Character Count:** 106597
**Document Hash:** b755f2f18bdbd59605839b81532f15bc
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-23-005142.hdr.sgml**: 20230110

**ACCESSION NUMBER**: 0001193125-23-005142

**CONFORMED SUBMISSION TYPE**: SC TO-C

**PUBLIC DOCUMENT COUNT**: 35

**FILED AS OF DATE**: 20230110

**DATE AS OF CHANGE**: 20230110

**SUBJECT COMPANY**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** ALBIREO PHARMA, INC.
- **CENTRAL INDEX KEY:** 0001322505
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** SC TO-C
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 005-83386
- **FILM NUMBER:** 23519617

**BUSINESS ADDRESS:**
- **STREET 1:** 10 POST OFFICE SQUARE
- **STREET 2:** SUITE 502 SOUTH
- **CITY:** BOSTON
- **STATE:** MA
- **ZIP:** 02109
- **BUSINESS PHONE:** 857-415-4774

**MAIL ADDRESS:**
- **STREET 1:** 10 POST OFFICE SQUARE
- **STREET 2:** SUITE 502 SOUTH
- **CITY:** BOSTON
- **STATE:** MA
- **ZIP:** 02109

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Biodel Inc
- **DATE OF NAME CHANGE:** 20050331
**FILED BY**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Ipsen, S.A.
- **CENTRAL INDEX KEY:** 0001370483
- **IRS NUMBER:** 000000000
- **STATE OF INCORPORATION:** I0
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** SC TO-C

**BUSINESS ADDRESS:**
- **STREET 1:** 42, RUE DU DOCTEUR BLANCHE
- **CITY:** PARIS
- **STATE:** I0
- **ZIP:** 75016
- **BUSINESS PHONE:** 011 33144961010

**MAIL ADDRESS:**
- **STREET 1:** 42, RUE DU DOCTEUR BLANCHE
- **CITY:** PARIS
- **STATE:** I0
- **ZIP:** 75016

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**UNITED STATES** 

**SECURITIES AND EXCHANGE COMMISSION** 

**Washington, D.C. 20549** 

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**SCHEDULE TO** 

**TENDER OFFER STATEMENT UNDER SECTION 14(D)(1) OR 13(E)(1)** 

**OF THE SECURITIES EXCHANGE ACT OF 1934** 

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## ALBIREO PHARMA, INC.
**(Name of Subject Company (Issuer))** 

**ANEMONE ACQUISITION CORP.** 

**(Offeror)** 

**a wholly owned subsidiary of** 

**IPSEN BIOPHARMACEUTICALS, INC.** 

**(Offeror)** 

**a wholly owned subsidiary of** 

**IPSEN PHARMA SAS** 

**(Offeror)** 

**a wholly owned subsidiary of** 

**IPSEN S.A.** 

**(Offeror)** 

**(Names of Filing Persons (identifying status as offeror, issuer or other person))** 

**Common Stock, Par Value $0.01 Per Share** 

**(Title of Class of Securities)** 

**01345P106** 

**(CUSIP Number of Class of Securities)** 

**Francois Garnier, EVP, General Counsel and Chief Business Officer** 

**Ipsen Pharma SAS** 

**65 Quai Georges Gorse** 

**92100 Boulogne-Billancourt, France** 

**Tel. +33 1 58 33 50 00** 

**(Name, Address and Telephone Number of Person Authorized to Receive Notices and Communications on Behalf of Filing Persons)** 

***Copies to:***

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| | |
|:---|:---|
| **Tony Chan, Esq.**<br> **Orrick, Herrington & Sutcliffe LLP**<br> **Columbia Center**<br> **1152 15th Street, N.W.**<br> **Washington, DC 20005-1706** | **Niki Fang, Esq.**<br> **Orrick, Herrington & Sutcliffe LLP**<br> **The Orrick Building**<br> **405 Howard Street**<br> **San Francisco, CA 94105-2669** |

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**CALCULATION OF FILING FEE** 

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| | |
|:---|:---|
| &nbsp;&nbsp;&nbsp;**Transaction Valuation\*** | **Amount of Filing Fee\*** |
| &nbsp;&nbsp;&nbsp;Not applicable\* | Not applicable\* |

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\* A filing fee is not required in connection with this filing as it relates solely to preliminary communications made before the commencement of a tender offer.

☒ Check the box if the filing relates solely to preliminary communications made before the commencement of a
tender offer.

Check the appropriate boxes below to designate any transactions to which the statement relates:

☒ third-party tender offer subject to Rule 14d-1.

☐ issuer tender offer subject to Rule 13e-4.

☐ going-private transaction subject to Rule 13e-3.

☐ amendment to Schedule 13D under Rule 13d-2.

Check the following box if the filing is a final amendment reporting the results of the tender offer. ☐

If applicable, check the appropriate box(es) below to designate the appropriate rule provision(s) relied upon:

☐ Rule 13e-4(i) (Cross-Border Issuer Tender Offer)

☐ Rule 13d-1(d) (Cross-Border Third-Party Tender Offer)

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The pre-commencement communication filed under cover of this Schedule TO relates to a planned tender offer (the "Offer") by Anemone Acquisition Corp., a Delaware corporation ("Purchaser") and a wholly owned subsidiary of Ipsen Biopharmaceuticals, Inc., a Delaware corporation ("Parent"), for all of the issued and outstanding shares of common stock, par value $0.01 per share (the "Common Stock"), of Albireo Pharma, Inc. (the "Company"), pursuant to an Agreement and Plan of Merger, dated as of January 8, 2023 (the "Merger Agreement"), by and among the Company, Parent, Purchaser and Ipsen Pharma SAS, a French société par actions simplifiée, as Guarantor for certain purposes under the Merger Agreement ("Guarantor"). Guarantor is a wholly owned subsidiary of Ipsen S.A., a French société anonyme.

The Offer for the outstanding shares of Common Stock has not yet commenced. This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell securities. The solicitation and offer to buy shares of Common Stock will only be made pursuant to the tender offer materials that Ipsen, Parent, Purchaser and Guarantor intend to file with the U.S. Securities and Exchange Commission (the "SEC") upon commencement of the Offer. At the time the Offer is commenced, Ipsen, Parent, Purchaser and Guarantor will file a tender offer statement on Schedule TO with the SEC, and the Company will file a solicitation/recommendation statement on Schedule 14D-9 ("Solicitation/Recommendation Statement") with the SEC with respect to the Offer. THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 WILL CONTAIN IMPORTANT INFORMATION. THE COMPANY'S STOCKHOLDERS ARE URGED TO READ THESE DOCUMENTS CAREFULLY WHEN THEY BECOME AVAILABLE (AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME) BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT HOLDERS OF THE COMPANY'S SECURITIES SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SECURITIES. Both the tender offer statement and the Solicitation/Recommendation Statement will be mailed to the Company's stockholders free of charge. Once filed with the SEC, Company stockholders will be able to obtain a free copy of these materials and other documents with respect to the Offer at the website maintained by the SEC at www.sec.gov. The tender offer materials may also be obtained (when available) free of charge on the Company's internet website at www.albireopharma.com, by contacting the Company's Investor Relations Department at (857) 254-5555 or by contacting the information agent for the tender offer who will be named in the tender offer materials.

**EXHIBIT INDEX** 

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| | |
|:---|:---|
| **Exhibit** | **Description** |
| 99.1 | [Joint Press Release dated January 9, 2023.](d427101dex991.htm) |
| 99.2 | [Investor Presentation dated January 9, 2023.](d427101dex992.htm) |
| 99.3 | [Transcript of Webcast on January 9, 2023.](d427101dex993.htm) |

---

## Exhibit 99.1

**Exhibit 99.1** 

Disclaimer: Intended for international media and investor audiences only

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| | | |
|:---|:---|:---|
| &nbsp;&nbsp; ![LOGO](g427101g0110030436107.jpg)  | ![LOGO](g427101g0110030436201.jpg)  | ![LOGO](g427101g0110030436388.jpg)  |

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**Ipsen to acquire Albireo accelerating growth in rare disease with treatments for several pediatric liver diseases** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Transaction focused on Bylvay<sup>®</sup> (odevixibat), the
first-approved treatment in progressive familial intrahepatic cholestasis in U.S. and E.U., with potential in other rare diseases

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Acquisition aligned with Ipsen's long-term strategy for expanding the scope of its Rare Disease portfolio
and pipeline

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Ipsen to commence cash tender offer to acquire all issued and outstanding shares of Albireo for $42.00 per share
plus a contingent value right (CVR) of $10.00 per share related to the U.S. FDA approval of Bylvay in biliary atresia

**PARIS, FRANCE & BOSTON, U.S.,** 09 January 2023 – Ipsen (Euronext: IPN: ADR: IPSEY) and Albireo (Nasdaq: ALBO) today announced that they have entered into a definitive merger agreement under which Ipsen will acquire Albireo, a leading innovator in bile-acid modulators to treat pediatric and adult cholestatic liver diseases. The anticipated acquisition will enrich Ipsen's Rare Disease portfolio and pipeline.

The lead medicine in Albireo's pipeline is Bylvay<sup>®</sup> (odevixibat), a potent, once-daily, oral, non-systemic ileal bile acid transport inhibitor (IBATi). Bylvay was approved in 2021 in the U.S. for the treatment of pruritus in patients three months of age and older with progressive familial intrahepatic cholestasis (PFIC)<sup>1</sup>, and in the E.U. for the treatment of PFIC in patients aged six months or older.<sup>2</sup> Pruritus is one of the most prominent and problematic manifestations of the disease,<sup>3</sup> often resulting in severely diminished quality of life.<sup>4</sup> Bylvay has orphan exclusivity for the approved indications in PFIC in the U.S. and E.U.

"We are excited about the potential of Albireo's assets and scientific expertise, which we gain through this acquisition, and we believe this is a compelling growth opportunity for Ipsen." said David Loew, Chief Executive Officer of Ipsen. "Our Rare Disease franchise is strengthened with Bylvay, which, in addition to being the first-approved treatment in PFIC, has two further indications being investigated in rare liver conditions that are underserved. Additionally, Bylvay and the clinical and preclinical novel bile acid transport inhibitors in Albireo's portfolio complement our own pipeline in liver disease."

"Unwavering dedication to patients and commitment to science have always been the north star for Albireo. This focus has driven us to develop and gain approval for Bylvay as the first drug treatment for PFIC," said Ron Cooper, President and Chief Executive Officer of Albireo. "Our talented team at Albireo have advanced the first Phase III studies in three different pediatric liver diseases while discovering two promising new clinical stage bile acid modulators. We believe that Ipsen is well positioned to apply its global R&D and commercial capabilities to make these medicines available to more cholestatic liver disease patients and accelerate the mission of providing hope for families. "

In addition to this lead indication, Albireo announced in December 2022 that supplementary regulatory filings have been made for Bylvay in the E.U. and the U.S. for Alagille syndrome (ALGS). ALGS is a rare, genetic disorder that can affect multiple organ systems, including the liver, with a paucity of bile ducts preventing bile flow from the liver to the small intestine. The most debilitating symptom of ALGS is severe pruritus.<sup>5</sup> In the Phase III ASSERT trial, treatment with Bylvay met both primary and secondary endpoints and was associated with statistically significant improvements in pruritus severity and reductions in serum bile acid levels compared to placebo, and was well tolerated.<sup>6</sup>

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Disclaimer: Intended for international media and investor audiences only

Furthermore, Bylvay is in late-stage development for biliary atresia (BA). It is currently being investigated in the BOLD study, the first, prospective double-blind, Phase III clinical trial in BA, a rare, pediatric liver disease that can result in cirrhosis and liver failure and is the leading cause of liver transplantation among children.<sup>7</sup> Orphan drug designations have been granted in both ALGS and BA indications in the U.S. and E.U.

As part of the transaction, Ipsen will also acquire Albireo's clinical stage asset A3907, a novel oral systemic apical sodium-dependent bile acid transporter (ASBT) inhibitor currently in development for adult cholestatic liver disease, such as primary sclerosing cholangitis (PSC), which could complement Ipsen's existing development programs. In addition to Bylvay and A3907, Albireo's pipeline includes A2342, an oral systemic sodium-taurocholate co-transporting peptide (NTCP) inhibitor being evaluated for viral and cholestatic diseases, which is moving ahead in investigational new drug (IND)-enabling trials.

**Financial highlights** 

The acquisition of Albireo will provide immediate incremental sales and strengthen Ipsen's rare disease infrastructure. Albireo guided for total Bylvay revenues of $24 million for 2022. Given the level of ongoing R&D expenses, the transaction is expected to be dilutive to Ipsen's core operating income until the end of 2024. This is in line with Ipsen's medium-term outlook regarding its strategic focus on building a highvalue and sustainable pipeline through external innovation. The Group will provide its annual guidance for 2023 in February.

**Transaction details** 

Under the terms of the agreement and plan of merger, Ipsen, through a fully-owned subsidiary, will initiate a tender offer to acquire all outstanding shares of Albireo at a price of $42.00 per share in cash at the closing of the transaction, for an initial estimated aggregate consideration of $952 million plus one contingent value right (CVR) per share. Each CVR will entitle its holder to deferred cash payments of $10.00 per CVR payable upon the U.S. Food and Drug Administration (FDA) approval of Bylvay in the Biliary Atresia indication at the latest by 31 December 2027, allowing for a potential increase in the number of patients in the BOLD study.

The $42.00 per-share cash consideration represents a premium of 104% compared to Albireo's 1-month volume-weighted average price of $20.60 preceding announcement of the transaction. The transaction will be fully financed by Ipsen's existing cash and lines of credit. The Board of Directors of Albireo has unanimously approved the transaction and recommended that the stockholders of Albireo tender their shares in the tender offer.

The closing of the tender offer will be subject to customary conditions, including the tender of shares which represent at least a majority of the total number of Albireo's outstanding shares, the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and the receipt of consents of, or filings with, any governmental body or pursuant to certain foreign antitrust laws and the expiration of any applicable waiting period and other customary conditions. Upon the successful completion of the tender offer, Ipsen would acquire all shares not acquired in the tender offer through a second-step merger for the same consideration that the tendering stockholders will receive in the tender offer. It is anticipated the transaction will close by end of Q1, 2023.

**Advisors** 

Goldman Sachs is acting as exclusive financial advisor to Ipsen and Orrick Herrington & Sutcliffe LLP as legal counsel to Ipsen. Centerview Partners is serving as exclusive financial advisor to Albireo. Chestnut Partners also provided advice to Albireo. Paul, Weiss, Rifkind, Wharton & Garrison and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C are serving as legal counsel to Albireo.

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Disclaimer: Intended for international media and investor audiences only

**Conference call** 

A conference call and webcast for investors and analysts will begin today at 3pm, Paris time. Participants can access the call and its details by registering <u>here</u>; webcast details can be found <u>here</u>. A recording will be available on <u>ipsen.com</u>.

**ENDS** 

**About Bylvay<sup>®</sup> (odevixibat)** 

Bylvay (odevixibat) is a potent, non-systemic ileal bile acid transport inhibitor (IBATi). It is approved in the U.S. for the treatment of pruritus in patients three months of age and older with PFIC,<sup>1</sup> where it has orphan exclusivity. Bylvay is launched in the U.S., where it is supported by a program designed to assist with access to treatment and patient support. Bylvay is also approved in the E.U. for the treatment of PFIC in patients aged six months or older.<sup>2</sup> It has launched in over nine countries and has secured public reimbursement across several major markets including Germany, Italy, UK, France and Belgium.

View full E.U. prescribing information here: <u>Bylvay, INN-odevixibat (europa.eu)</u>

View full U.S. prescribing information here: <u>label (fda.gov)</u>

A second potential indication for Bylvay in patients with ALGS has been submitted as a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) and a variation application to the European Medicines Agency (EMA) in December 2022.

Bylvay is being investigated in biliary atresia, a severe and potentially fatal pediatric liver disease, in a pivotal Phase III clinical trial.

**About PFIC** 

PFIC is a spectrum<sup>8-11</sup> of autosomal recessive genetic disorders in which cholestasis may lead to endstage liver disease.<sup>12</sup> The estimated global incidence of PFIC is 1 in 100,000 live births.<sup>12</sup> Currently in the U.S., it is estimated that there are 500 PFIC patients who may be eligible for IBATi treatment. Subtypes PFIC1, PFIC2 and PFIC3 are the most common.<sup>12</sup> In addition, other rare forms of PFIC exist with varying degrees of cholestasis.<sup>13</sup> Patients with PFIC have impaired bile flow, or cholestasis, and the resulting bile build-up in liver cells causes liver disease and symptoms. The most debilitating symptom of PFIC is pruritus (itching), which may be so severe that it leads to skin mutilation, loss of sleep, irritability, poor attention and impaired school performance.<sup>11</sup> Up to 80% of PFIC patients suffer from severe pruritus, associated with abrasions, skin mutilation, hemorrhage or scarring.<sup>14</sup>

**About PEDFIC 1 and 2** 

The PEDFIC trials (NCT03566238 and NCT03659916) represented the largest trials ever completed in children with PFIC. PEDFIC 1 was a randomized, double-blind, placebo-controlled Phase III trial aiming to evaluate the efficacy and tolerability of Bylvay in reducing pruritus and serum bile acids (sBAs) in children with PFIC. All patients enrolled in PEDFIC-1 were eligible to participate in PEDFIC 2, a long-term, open-label extension phase.

**About Alagille syndrome** 

ALGS is an inherited rare, genetic disorder that can affect multiple organ systems in the body including the liver, heart, skeleton, eyes and kidneys. Liver damage may result from having fewer than normal, narrowed or malformed bile ducts, which leads to toxic bile acid build-up, which in turn can cause scarring and progressive liver disease.<sup>15</sup> Approximately 95% of patients with the condition present with chronic cholestasis, usually within the first three months of life and as many as 88% also present with severe, intractable pruritus.<sup>16,17</sup> The estimated global incidence of ALGS is 3 in 100,000 live births.<sup>18</sup> Currently in the U.S., it is estimated that there are 1,300 patients who may be eligible for IBATi treatment.

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Disclaimer: Intended for international media and investor audiences only

**About ASSERT** 

ASSERT (NCT04674761) is a double-blind, randomized, placebo-controlled trial designed to evaluate the safety and efficacy of Bylvay (odevixibat) for 24 weeks in patients with ALGS up to 17 years of age. The primary endpoint evaluates the impact of odevixibat on pruritus score compared to placebo. Key secondary endpoints measure changes in serum bile acid levels and safety and tolerability. Top-line results were presented at the American Association for the Study of Liver Disease (AASLD) Conference in November 2022, supporting the efficacy and safety of Bylvay in patients with ALGS: Improvement in pruritus scores and reduction in serum bile acid levels were statistically significant compared to placebo. Additionally, Bylvay led to significant sleep improvements over time. There were no trial discontinuations and all patients completed the initial 24 weeks treatment duration, with 96% rolled over into the open-label extension trial. Low rates of diarrhea were reported during the trial.

**About biliary atresia** 

BA is a rare pediatric liver disease. Symptoms typically develop about two to eight weeks after birth and there are no approved pharmacological therapies. Damaged or absent bile ducts outside the liver result in bile and bile acids being trapped inside the liver, quickly resulting in cirrhosis and liver failure requiring liver transplantation. At the time of diagnosis, a hepatic portoenterostomy (HPE) called Kasai procedure is performed to create a conduit allowing biliary drainage. The rate of success in re-establishing bile flow is dependent on the age of the infant when the HPE is performed. Kasai procedure is not curative and most patients who have BA have progressive disease, with at least 80% requiring liver transplantation by age 20 years.<sup>19</sup> Of those who survive into the third decade after birth, almost all have portal hypertension or other complications of cirrhosis.<sup>20</sup> New therapies are therefore needed to delay or avoid the need for liver transplantation following Kasai procedure.<sup>21</sup> There are currently no approved pharmacological treatments for biliary atresia. There is an estimated incidence of 5/6 per 100,000 live births worldwide with BA<sup>22</sup>. Currently in the U.S., it is estimated that there are 750 patients who may be eligible for IBATi treatment.

**About BOLD** 

BOLD (NCT04336722) is a double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of Bylvay (odevixibat) in children who have biliary atresia and have undergone a Kasai procedure before age three months. Children in the treatment arm receive Bylvay 120 µg/kg orally once daily for 24 months. The primary efficacy endpoint is improvement in the proportion of patients who are alive and have not undergone a liver transplant after two years of treatment compared to placebo, and secondary outcome measures include time to onset of any sentinel events, total bilirubin levels and sBA levels.

**About Albireo** 

Albireo is a rare disease company focused on the development of novel bile acid modulators to treat pediatric and adult liver diseases. Albireo's lead product, Bylvay, was approved by the U.S. FDA as the first drug for the treatment of pruritus in all types of progressive familial intrahepatic cholestasis (PFIC), and in Europe for the treatment of PFIC. Bylvay is also being developed to treat other rare pediatric cholestatic liver diseases with a completed Phase III trial in ALGS, an ongoing Phase III study in biliary atresia, as well as Open-label Extension (OLE) studies for PFIC and ALGS. The company has also completed a Phase I clinical trial for A3907 to advance development in adult cholestatic liver disease, with IND-enabling studies progressing with A2342 for viral and cholestatic liver disease. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com.

**About Ipsen** 

Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With Specialty Care sales of €2.6bn in FY 2021, Ipsen sells medicines in over 100 countries. Alongside its external-innovation strategy, the Company's research and development efforts are focused on its innovative and differentiated technological platforms located in the heart of leading biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen has around 5,000 colleagues worldwide and is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit <u>ipsen.com</u>

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Disclaimer: Intended for international media and investor audiences only

**<u>For further information:</u>**

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| | |
|:---|:---|
| **Ipsen Contacts**<br>**<u>Investors</u>** | **Ipsen Contacts**<br>**<u>Investors</u>** |
| **Craig Marks**<br> Vice President, Investor Relations<br> +44 (0)7584 349 193 | **Adrien Dupin de Saint-Cyr**<br>Investor Relations Manager<br> +33 6 64 26 17 49 |
| **<u>Media</u>** | **<u>Media</u>** |
| **Anna Gibbins**<br>Global Head of Franchise Communications,<br> Rare Disease<br> +44 7717801900<br>**Amy Wolf**<br>VP, Head of Corporate Brand Strategy<br> +41 79 576 07 23 | **Ioana Piscociu**<br>Senior Manager<br> Global Media Relations<br> +33 6 69 09 12 96 |
| **Albireo Contacts**<br>**<u>Media & Investors</u>**<br>**Colleen Alabiso**<br>Senior Vice President, Corporate Affairs<br> 857-356-3905<br> <u>colleen.alabiso@albireopharma.com</u><br>**Hans Vitzthum**<br>LifeSci Advisors, LLC.<br> 617-430-7578 | **Albireo Contacts**<br>**<u>Media & Investors</u>**<br>**Colleen Alabiso**<br>Senior Vice President, Corporate Affairs<br> 857-356-3905<br> <u>colleen.alabiso@albireopharma.com</u><br>**Hans Vitzthum**<br>LifeSci Advisors, LLC.<br> 617-430-7578 |

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**Albireo Forward-Looking Statements** 

Statements contained in or incorporated by reference into this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, the tender offer, the merger and related transactions are forward-looking statements. Forward-looking statements are statements that are not historical facts and may include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by words such as "anticipates," "believes," "plans," "expects," "projects," "future," "intends," "may," "will," "should," "could," "estimates," "predicts," "potential," "planned," "continue," "guidance," or the negative of these terms or other similar expressions. Forward-looking statements may include statements, other than statements of historical fact, regarding, among other things: the Albireo's commercialization plans; the plans for, or progress, scope, cost, initiation, duration, enrollment, results or timing for availability of results of, development of Bylvay,

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Disclaimer: Intended for international media and investor audiences only

A3907, A2342 or any other Albireo product candidate or program; the target indication(s) for development or approval; potential regulatory approval and plans for potential commercialization of Bylvay in biliary atresia or ALGS or in additional countries, or the Albireo's other product candidates; the timing for initiation or completion of or availability or reporting of results from any clinical trial; the potential benefits or competitive position of the Albireo or any other Albireo product candidate or program or the commercial opportunity in any target indication; the Albireo's plans, expectations or future operations, financial position, revenues, costs or expenses; statements regarding the expected timing of the completion of the transactions contemplated by the merger agreement; statements regarding the ability to complete the transactions contemplated by the merger agreement considering the various closing conditions; the projected financial information; and any statements regarding assumptions underlying any of the foregoing. Although the Albireo's management believes that the expectations reflected in such forward- looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Albireo, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, (i) uncertainties as to the timing of the transactions contemplated by the merger agreement; (ii) the risk that the transactions contemplated by the merger agreement may not be completed in a timely manner or at all; (iii) uncertainties as to the percentage of the Albireo's stockholders tendering their Shares in the Offer; (iv) the possibility that competing offers for the Albireo may be made; (v) the possibility that any or all of the various conditions to the consummation of the transactions contemplated by the merger agreement may not be satisfied or waived, including the failure to receive any required regulatory approvals (or any conditions, limitations or restrictions placed on such approvals); (vi) the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement, including in circumstances which would require the Albireo to pay a termination fee; (vii) the risk that the milestone specified in the CVR Agreement is not achieved; (viii) the effect of the announcement or pendency of the transactions contemplated by the merger agreement on the Albireo's ability to retain and hire key personnel, its ability to maintain relationships with its customers, suppliers and others with whom it does business, or its business generally; (ix) risks related to diverting management's attention from the Albireo's ongoing business operations; (x) the risk that stockholder litigation in connection with the transactions contemplated by the merger agreement may result in significant costs of defense, indemnification and liability; as well as (xi) risks and uncertainties pertaining to the Albireo's business, including those detailed under "Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements" in the Albireo's annual report on Form 10- K for the year ended December 31, 2021, quarterly reports on Form 10-Q and current reports on Form 8- K filed with the U.S. Securities and Exchange Commission (SEC), such as the risk that the regulatory filings made for Bylvay in patients with ALGS will not be approved by the FDA and EMA and on the timelines the Albireo anticipates; the risk that the FDA and EMA will not complete their respective reviews within target timelines, once determined; the risk that the FDA and EMA will require additional information, the risk that we will not be able to provide in a timely manner any additional information that the FDA and EMA request, and the risk that such additional information will not be satisfactory to the FDA and EMA; the risk that Bylvay will not be commercially successful; the risk that we may encounter issues, delays or other challenges in commercializing Bylvay; the risk that Bylvay does not receives acceptance from patients and physicians for its approved indication; the risk of challenges associated with execution of the Albireo's sales activities, which in each case could limit the potential of its product; the risk of challenges associated with supply and distribution activities, which in each case could limit the Albireo's sales and the availability of its product; the risk of potential negative impacts of the COVID-19 pandemic, including on manufacturing, supply, conduct or initiation of clinical trials, or other aspects of our business; the risk that favorable findings from clinical trials of Bylvay to date, including findings in PFIC, ALGS and other indications, will be predictive of results from other clinical trials of Bylvay; the risk that Bylvay will not be approved in jurisdictions or for indications beyond the jurisdictions in which or indications (such as biliary atresia or ALGS) for which Bylvay is currently approved; the risk that the Albireo's other product candidates will not be approved; the risk that estimates of the addressable patient population for target indications may prove to be incorrect; the outcome and interpretation by regulatory authorities of the ongoing third-party study pooling and analyzing of long-term PFIC patient data; the timing for initiation or

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Disclaimer: Intended for international media and investor audiences only

completion of, or for availability of data from, clinical trials of Bylvay, including BOLD, and the Phase 2 clinical trial of A3907, and the outcomes of such trials; the Albireo's ability to obtain coverage, pricing or reimbursement for approved products in the United States or Europe; delays or other challenges in the recruitment of patients for, or the conduct of, the Albireo's clinical trials; any repurchase by the Albireo of Sagard's interest in the royalty interest payments under our royalty monetization agreement with Sagard could materially impact our financial condition; and the Albireo's critical accounting policies. The forward- looking statements speak only as of the date hereof and, other than as required by applicable law, none of the Albireo, Ipsen or any of their respective affiliates undertakes any obligation to update or revise any forward-looking information or statements.

**Ipsen's forward-looking statements** 

The forward-looking statements, objectives and targets contained herein are based on Ipsen's management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen's future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words 'believes', 'anticipates' and 'expects' and similar expressions are intended to identify forward-looking statements, including Ipsen's expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen's patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen's activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen's partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen's business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward- looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen's business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen's 2021 Universal Registration Document, available on <u>ipsen.com</u>

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Disclaimer: Intended for international media and investor audiences only

**About the Offer** 

The tender offer for the outstanding shares of Albireo common stock referenced in this press release has not yet commenced. This press release is for informational purposes only and is not a recommendation, an offer to purchase or a solicitation of an offer to sell securities, nor is it a substitute for the tender offer materials that Ipsen Biopharmaceuticals, Inc. (Parent) and its acquisition subsidiary will file with the SEC, upon the commencement of the tender offer. At the time the tender offer is commenced, Parent and its acquisition subsidiary will file with the SEC a tender offer statement on Schedule TO and thereafter Albireo will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. Once filed, stockholders will be able to obtain a free copy of these materials and other documents filed by Parent and its acquisition subsidiary and Albireo with the SEC at the website maintained by the SEC at www.sec.gov. The tender offer materials (including an Offer to Purchase, a related Letter of Transmittal and certain other tender offer documents) may also be obtained (when available) for free by contacting the information agent for the tender offer.

THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 WILL CONTAIN IMPORTANT INFORMATION. ALBIREO'S STOCKHOLDERS ARE URGED TO READ THESE DOCUMENTS CAREFULLY WHEN THEY BECOME AVAILABLE (AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME) BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT HOLDERS OF ALBIREO'S SECURITIES SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SECURITIES.

Additional copies of the tender offer materials and the Solicitation/Recommendation Statement (when available) may be obtained for free by contacting Parent or Albireo. Copies of the documents filed with the SEC by Albireo will be available free of charge on Albireo's internet website at www.albireopharma.com or by contacting Albireo's Investor Relations Department at 857 254-5555. Additional Information

In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Albireo files annual, quarterly and current reports and other information with the SEC. You may read and copy any reports or other information filed by Albireo at the SEC public reference room at 100 F. Street, N.E., Washington D.C. 20549. Please call the Commission at 1-800-SEC-0330 for further information on the public reference room. Albireo's filings with the SEC are available to the public from the website maintained by the SEC at www.sec.gov.

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1. <u>label (fda.gov)</u> 

2. <u>Bylvay, INN-odevixibat (europa.eu)</u> 

3. Gunaydin M. Hepat Med 2018;10:95-104. doi: 10.2147/HMER.S137209

4. Srivastava A J. Clin Exp Hepatol 2014;4:25-36

5. Ayoub MD. Diagnostics (Basel) 2020;10(11):907. doi:10.3390/diagnostics10110907

6. Albireo Reports Positive Topline Data from Phase 3 Trial of Bylyay (odevixibat) in Alagille syndrome. <u>Albireo Reports Positive Topline Data from Phase 3 Trial of Bylvay<sup>®</sup> (odevixibat) in Alagille Syndrome \| Albireo (Albireopharma.com)</u> Last accessed: 29 December 2022

7. Sundaram S S. Liver Transpl 2017;23:96-109 doi: 10.1002/It.24640

8. Henkel S. World J Hepatol. 2019;11(5):450-463

9. Schatz B. Hepatol Commun. 2018;2(5):504-514

10. Aldrian D. J Clin Med. 2021;10(3):481

11. Folmer D E. Hepatology 2009;50(5):1597-1605

12. Davit-Spraul A. Orphanet J Rare Dis. 2009;4:1

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Disclaimer: Intended for international media and investor audiences only

13. Amirneni S World J Gastroenterol. 2020;26(47):7470- 7484

14. Baker A. Clin Res Hepatol Gastroenterol. 2019;43(1):20-36

15. U.S. Department of Health and Human Services. Alagille syndrome- about the disease. Genetic and rare diseases
information center. <u>https://rare-diseases.info.nih.gov/diseases/804/alagille-syndrome</u> 

16. Singh S P.Euroasian J Hepatogastroenterol. 2018;8(2):140-147

17. Feldman A G. Neoreviews 2013;14 (2): e63–e73

18. Leonard L. European Journal of Human Genetics. 2014; 22:435

19. Lykavieris P. Heptology. 2005;4 (2):366-371

20. Jain V. Hepatology. 2001;73 (1); 93-98

21. Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD) - Full
Text View - ClinicalTrials.gov

22. Hopkins P J Pediatr. 2017;187:253-257. doi: 10.1016/j.jpeds.2017.05.006. Epub 2017 Jun 1.

## Exhibit 99.2

![](g427101ex99_2p1g1.jpg)

Exhibit 99.2 Bring The full potential of our innovative medicines to patients The acquisition of Albireo Build A high-value sustainable pipeline 9 January 2023 Deliver Efficiencies to enable targeted investment & growth Boost Focus. Together. A culture of collaboration For patients & society & excellence 1

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![](g427101ex99_2p2g1.jpg)

Disclaimer & safe harbor - This presentation includes only summary information and does not purport to be comprehensive. Forward-looking statements, targets and estimates contained herein are for illustrative purposes only and are based on management's current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated in the summary information. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably given that a new medicine can appear to be promising at a preparatory stage of development or after clinical trials but never be launched on the market or be launched on the market but fail to sell notably for regulatory or competitive reasons. Ipsen must deal with or may have to deal with competition from generic medicines that may result in market-share losses, which could affect its level of growth in sales or profitability. The Company expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this presentation to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. - All medicine names listed in this document are either licensed to Ipsen or are registered trademarks of Ipsen or its partners. - The implementation of the strategy has to be submitted to the relevant staff representation authorities in each country concerned, in compliance with the specific procedures, terms and conditions set forth by each national legislation. - In those countries in which public or private-health cover is provided, Ipsen is dependent on prices set for medicines, pricing and reimbursement-regime reforms and is vulnerable to the potential withdrawal of certain medicines from the list of reimbursable medicines by governments, and the relevant regulatory authorities in its locations. In light of recent economic conditions, there could be increased pressure on the pharmaceutical industry to lower medicine prices. - Ipsen operates in certain geographical regions whose governmental finances, local currencies or inflation rates could erode the local competitiveness of Ipsen's medicines relative to competitors operating in local currency, and/or could be detrimental to Ipsen's margins in those regions where Ipsen's sales are billed in local currencies. - In a number of countries, Ipsen markets its medicines via distributors or agents; some of these partners' financial strengths could be impacted by changing economic or market conditions, potentially subjecting Ipsen to difficulties in recovering its receivables. Furthermore, in certain countries whose financial equilibrium is threatened by changing economic or market conditions, and where Ipsen sells its medicines directly to hospitals, Ipsen could be forced to lengthen its payment terms or could experience difficulties in recovering its receivables in full. - Ipsen also faces various risks and uncertainties inherent to its activities identified under the caption 'Risk Factors' in the Company's Universal Registration Document. - All of the above risks could affect Ipsen's future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available at the time. 2

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Speakers David Loew Howard Mayer Aymeric Le Chief Executive Officer Head of Chatelier Research & Development Chief Financial Officer 3

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Agenda 1 3 5 6 2 4 Conclusion Commercial Strategic opportunities rationale Questions Financials The science 4

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STRATEGIC RATIONALE 5

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The focus on three therapy areas To be a leading global, mid-sized biopharmaceutical company with a focus on transformative medicines Our vision in Oncology, Rare Disease & Neuroscience O N C O L O G Y R A R E D I S E A S E N E U R O S C I E N C E Strengthening Expanding Excelling & the position the scope accelerating 6

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Albireo: expanding Ipsen's scope in Rare Disease Perfectly aligned to the external-innovation strategy 1 Global rights Multiple opportunities • Bylvay: a potentially best-in-class • Bylvay: progressive familial rare liver-disease medicine intrahepatic cholestasis, Alagille approved in the U.S. & E.U. syndrome, biliary atresia • Early-stage pipeline: adult cholestatic liver diseases Strategic fit Financial impact • Expanding the pipeline • Sizeable peak sales ~$800m & portfolio in rare liver diseases • Accretive to core operating income from 2025 1. Except Japan. 7

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THE SCIENCE 8

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![](g427101ex99_2p9g1.jpg)

Pediatric cholestatic liver diseases Bile acids Chemicals made by the liver from cholesterol Transported from the liver to the intestines Help to absorb fats, fat soluble vitamins & nutrients for growth and development 95% recycled back to the liver & reused Failure of draining bile from liver to intestine Caused by defects in the intrahepatic production of bile, transmembrane transport of bile, or mechanical obstruction to bile flow 9

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Bylvay is a potent, oral non-systemic iBAT inhibitor that acts locally in the gut By blocking the actions of iBAT, Bylvay reduces the reabsorption of bile acids from the terminal ileum and their return to the liver Reducing the build-up of bile acids (cholestasis) will prevent progressive liver damage leading to cirrhosis, end-stage liver disease and need for liver transplant iBAT: ileal bile-acid transporter. 10

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PEDFIC 1 & 2 Phase III trials Bylvay demonstrated efficacy across multiple PFIC types 24 weeks 54 weeks PFIC1 PFIC2 PFIC3 PFIC6 N=12 N=30 N=5 N=1 Efficacy Patients with improved pruritus score 95% 80% 80% 100% Pruritus mean reduction vs. baseline (pts) -1.13 -1.13 -1.6 -1.8 -31.7 -120.8 -91 -78 sBA mean reduction vs. baseline µmol/L µmol/L µmol/L µmol/L • Bylvay was generally well tolerated Safety • Most TEAEs were mild to moderate in severity; no serious TEAEs, discontinuation or death PFIC: progressive familial intrahepatic cholestasis; sBA: serum bile acids; TEAEs: treatment-emergent adverse events. Source: Albireo Corporate Overview, November 2022. Reduction from baseline pruritus score (0 to 4 point scale). 11

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ASSERT: Alagille syndrome Double-blind placebo-controlled Phase III trial Significant Bylvay: well tolerated over 24 weeks, no discontinuations Source: Albireo data presentation, October 2022. 1. Least squares mean at weeks 21-24. 2. Least squares mean at weeks 20 and 24. 12

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BOLD: biliary atresia Double-blind placebo-controlled Phase III trial 24 months 205 patients Bylvay 120 mcg/kg/day ≤three months N=100 Open-label of age post- extension and Kasai safety follow-up (up to 27 months) placebo N=100 Primary Endpoint Proportion of patients who are alive and have not undergone a liver transplant 13

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COMMERCIAL OPPORTUNITIES PAGE 14

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Bylvay roadmap & commercial assumptions Development status iBAT-eligible population U.S. Indication Phase III Approved Incidence Prevalence (live births/year) (at time of launch) Eligible PFIC patients include incident & prevalent patients PFIC Approved ~30 ~500 < 17-yrs that have pruritus and have not had liver transplant Eligible ALGS patients include incident & prevalent patients < 17-yrs that have cholestasis, pruritus and have not had ~90 ~1,300 ALGS Submitted liver transplant Eligible BA patients will mainly be incident patients post- Kasai; lower iBAT eligibility in the prevalent BA patients due ~130 ~600 BA Ongoing to age, Kasai outcomes & transplant rates PFIC: progressive familial intrahepatic cholestasis; ALGS: Alagille syndrome; BA: biliary atresia; iBAT: ileal bile-acid transporter. Eligible patients: a literature review analyzing over 60 sources has been performed for the epidemiology estimation. Only non-liver-transplanted patients are shown in the prevalence population, which has been estimated based on native liver survival curves in each indication (sources: literature review and extensive market research). IBAT-eligibility cuts are included for each indication at steady state; include age, rate of pruritus in PFIC, rate of cholestasis and pruritus in ALGS, Kasai rate and Kasai success in biliary atresia (differs between newly-diagnosed incident and older prevalent population) (sources: literature review and extensive market research). Patient numbers are shown at expected launch year for each indication. 15

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Commercial opportunities: Bylvay 2 - Limited number of competitors: - Global rights : leveraging Ipsen's Bylvay leading in PFIC and biliary atresia infrastructure to accelerate sales of an with most advanced program for biliary approved medicine atresia - Convenient dosing: once per day capsules - Reimbursement secured across the E.U. & favorable coverage in the U.S. in PFIC 1 - Good patent life in the U.S. and E.U. - Data from ASSERT in ALGS support regulatory submissions 3 Peak-sales potential: around $800m 1. November 2031 for the U.S. and E.U., with pending patent-term-extension and supplementary-protection-certificate applications. 2. Except Japan. 3. Assuming success in all three indications, including approximately half from biliary atresia. 16 PFIC: progressive familial intrahepatic cholestasis; ALGS: Alagille syndrome.

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FINANCIALS PAGE 17 M E N T I O N S H E R E

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Financials 1 Ipsen to initiate a tender offer to acquire all outstanding shares of Albireo Offer price at $42.00 per share in cash at closing, equating to $952m Additional contingent-value payment of $10.00 per share, based on a potential U.S. regulatory approval of Bylvay in biliary atresia, equating to $244m Transaction expected to close by the end of Q1 2023, subject to the satisfaction of all closing conditions, including regulatory Accretive to core operating income from 2025 18

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CONCLUSION PAGE 19

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Conclusion Further execution of the external-innovation strategy - Expanding the scope in Rare Disease - Albireo: a leading innovator in bile-acid modulators for rare liver diseases - An on-market and potentially best-in-class medicine - Significant commercial opportunities - An excellent strategic fit 20

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QUESTIONS 21

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APPENDIX 22

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Bylvay development in three Rare Disease indications Alagille syndrome PFIC Biliary atresia Age ~1-2 years, Age ~2 weeks - 3 months, Age ~4-12 months, Presentation cholestasis, pruritus, failure to strive, acholic multiple symptoms jaundice stools, jaundice Autosomal dominant genes, Absence of bile ducts, no Cause or genetic Multiple genes, bile-acid paucity of bile ducts, bile-acid bile-acid flow, fatal without build-up in the liver disorder build-up in the liver Kasai surgery Serum bile-acid elevation Serum bile-acid elevation Disease Serum bile-acid elevation, inflammation, fibrosis, post-Kasai correlates with progression multiple organ impact cirrhosis, death lower native liver survival Almost no patients survive Many patients may need Kasai life-saving surgery Treatment & beyond age 20 without surgical diversion or liver ~80% of patients have liver surgical diversion or transplant. Disease can survival transplant in first two years liver transplant stabilize PFIC: progressive familial intrahepatic cholestasis. 23

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THANK YOU PAGE 24 M E N T I O N S H E R E

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Investor Relations Craig MARKS Adrien DUPIN DE SAINT-CYR Vice President, Investor Relations Investor Relations Manager +44 7564 349 193 +33 6 64 26 17 49 craig.marks@ipsen.com adrien.dupin.de.saint.cyr@ipsen.com 25

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Follow us www.ipsen.com PAGE 26 M E N T I O N S H E R E

## Exhibit 99.3

**Exhibit 99.3**<br>Company Name: Ipsen SA<br> Company Ticker: IPN FP Equity<br> Date: 2023-01-09<br>

![LOGO](g427101dsp1.jpg)

![LOGO](g427101dsp1new.jpg)

**Ipsen to Acquire Albireo Accelerating Growth Call** 

**Company Participants** 

• Aymeric Le Chatelier, Executive Vice President, Group Chief Financial Officer

• Craig Marks, Vice President, Investor Relations

• David Loew, Chief Executive Officer

• Howard Mayer, Executive Vice President, Head of Research and Development.

**Other Participants** 

• Alistair Campbell

• Analyst

• Charles Pitman

• Delphine Le Louet

• Jo Walton

• Michael Leuchten

• Richard Parkes

• Rosie Turner

• Simon Baker

**Presentation** 

**Operator** 

Hello, and welcome to the Ipsen Conference Call and Webcast on Acquisition of Albireo. I'll now hand you over to David Loew, Ipsen's CEO. Please go ahead, sir.

**David Loew** {BIO 18056474 }

Thank you, operator. Good afternoon or good morning, everyone. As you just heard, I'm David Loew, Chief Executive of Ipsen. We're live at the J.P. Morgan Healthcare Conference in San Francisco, and I'm delighted that you have joined us today as we take you through today's exciting news on the acquisition of Albireo. Please turn to Slide 2.

This is our usual Safe Harbor statement, which outlines the routine risks and uncertainties contained within this presentation. Please turn to Slide 3.

I'm joined today by Howard Mayer, Ipsen's Head of Research and Development; as well as our CFO, Aymeric Le Chatelier. We'll provide a brief presentation before using the majority of the time to answer your questions. Please turn to Slide 4.

Page 1 of 19

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Company Name: Ipsen SA Company Ticker: IPN FP Equity Date: 2023-01-09

![LOGO](g427101dsp1.jpg)

![LOGO](g427101dsp1new.jpg)

I will begin the presentation by taking you through the strategic rationale for the acquisition. I'll then hand over to Howard, who will explain the development of Bylvay. I will go through the commercial opportunities before Aymeric runs through the financials. I'll then conclude the presentation before we move to your questions. Please turn to Slide 5.

So firstly, let me turn to the strategic rationale for today's news. Please turn to Slide 6.

Underpinning our vision is a focus on three therapy areas. Within oncology, we have strengthened our position in the last two years by adding a dozen assets to our clinical and preclinical pipeline. We have also added further assets to our neuroscience pipeline. In rare disease, we look forward to the forthcoming Phase 3 results in primary biliary cholangitis for elafibranor, which was in-licensed around a year ago. But we do want to expand the scope in rare disease further, and it's this focus that has supported our decision to acquire Albireo. Please turn to Slide 7.

This expansion in rare disease is perfectly aligned to our external innovation strategy, which is designed to replenish our pipeline and add further medicines to our portfolio. The focus of this deal is on the potential of Bylvay, a possibly best-in-class rare liverdisease medicine with global rights that's already on the market for progressive familial intrahepatic cholestasis or PFIC in Europe and U.S.

There are multiple opportunities presented by this deal. We have the possibility of adding two further indications to the currently approved indication for Bylvay with Alagille syndrome and biliary atresia.

Furthermore, the acquisition also comes with an early-stage pipeline in adult cholestatic liver diseases. Bylvay and the clinical and preclinical novel bile acid transport inhibitors are clearly an excellent potential strategic fit in rare liver disease with elafibranor.

Financially, we anticipate sales of around $800 million and an accretive impact to core operating income from 2025. Please turn to Slide 8.

I hand over to Howard.

**Howard Mayer** {BIO 20100424 }

Thanks, David. And hello, everyone. I'd like to spend a few minutes taking you through do pediatric cholestatic liver diseases as well as the development of Bylvay. Please turn to Slide 9.

Bile acids are chemical compounds found in the liver made from cholesterol. Bile acids have several roles in the body, including promoting the flow and excretion of bile and assisting in the intestinal absorption of fat and fat-soluble vitamins and nutrients.

95% of bile acids are recycled back into the liver from the intestine and reused within the body. A disruption to this process can lead to the build-up of bile acids in the liver, which is known as cholestasis.

Page 2 of 19

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Company Name: Ipsen SA Company Ticker: IPN FP Equity Date: 2023-01-09

![LOGO](g427101dsp1.jpg)

![LOGO](g427101dsp1new.jpg)

Neonatal cholestasis reflects an underlying condition causing impaired flow of bile from liver cells into the intestine. This affects approximately 1 in 2,500 live births and about 50% have a known genetic origin. Patients with cholestasis experience symptoms such as intense and severe itching, poor sleep, delayed growth and diminished quality of life. Failure of bile outflow can ultimately cause obstructed bile ducts, portal hypertension, cirrhosis, and end-stage liver disease with some patients requiring liver transplantation. Please turn to Slide 10.

Bylvay or odevixibat is a potent, oral non-systemic ileal bile acid transporter inhibitor, approved in the U.S. and EU in 2021 for PFIC. By blocking the actions of iBAT, Bylvay reduces the reabsorption of bile acids from the terminal ileum and they return to the liver. Reducing buildup of bile acids or cholestasis prevents liver damage, leading to cirrhosis, end-stage liver disease and the need for liver transplantation. Please turn to Slide 11.

PFIC refers to a rare heterogeneous group of autosomal recessive disorders of childhood that disrupt bile production or secretion and presents with cholestasis that can lead to significant morbidity. The PEDFIC trials represented the largest trials ever completed in children with PFIC. PEDFIC 1 was a randomized double-blind placebo-controlled Phase 3 trial, aiming to evaluate the efficacy and tolerability of Bylvay and reducing pruritus and serum bile acids in children with PFIC.

All patients enrolled in PEDFIC 1 were eligible to participate in PEDFIC 2, a long-term open-label extension phase. Bylvay achieved the primary efficacy endpoint versus placebo and demonstrated efficacy across multiple PFIC types, including the percentage of patients with improved pruritus score, mean reduction in pruritus score from baseline, and reductions in serum bile acids from baseline. Bylvay was generally well tolerated. Most treatment-emergent adverse events were mild to moderate in severity. There were no serious treatment-emergent adverse events, discontinuations or deaths. Please turn to Slide 12.

Alagille syndrome is a rare autosomal dominant disorder caused by either inherited or spontaneous mutations in the JAG1 or NOTCH2 gene, which can affect normal development of multiple organ systems including the liver.

Many patients with Alagille syndrome will ultimately require biliary diversion or liver transplantation. ASSERT is a double-blind randomized placebo-controlled 24-week trial, designed to evaluate the safety and efficacy of Bylvay for people living with Alagille syndrome. Top line results were presented at the American Association for the Study of Liver Diseases Annual Meeting in November of last year.

In 52 patients with a mean age of 6, those who received Bylvay experienced statistically significant improvements in observer-reported scratching score from baseline to month six compared with placebo. And looking at the key secondary endpoint, serum bile acid levels dropped significantly with Bylvay versus placebo at 24 weeks. There were no trial discontinuations and all patients completed the initial 24-week treatment duration. 96% rolled over into the open-label extension trial. Please turn to Slide 13.

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Company Name: Ipsen SA Company Ticker: IPN FP Equity Date: 2023-01-09

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Biliary atresia is a rare pediatric liver disease with symptoms typically developing about two to eight weeks after birth and no approved pharmacological therapies. The disease is characterized by destruction or absence of all or a portion of the extrahepatic bile duct system. This results in bile and bile acids being trapped inside the liver, quickly resulting in cirrhosis and liver failure.

Kasai surgery or a hepatoportoenterostomy can be life-saving in patients that respond. However, about 50% of patients undergo a liver transplant in the first two years of life. BOLD is a double-blind randomized placebo-controlled trial to evaluate the safety and efficacy of Bylvay in children who have biliary atresia and have undergone a Kasai procedure before age three months and who are eligible to start treatment and randomize within three weeks of the procedure.

The primary efficacy endpoint is the proportion of patients who are alive and have not undergone a liver transplant after two years in the Bylvay arm compared to placebo. The study has enrolled 205 patients. And based on our due diligence, we are confident in the trial design and may increase the sample size of the study to maximize its probability of success. The FDA and EMA have indicated that a single pivotal study is sufficient to support filing.

Thank you for listening. I'll now hand back to David. Please turn to Slide 14.

**David Loew** {BIO 18056474 }

Thanks, Howard. I'm now going to outline commercial opportunities for Bylvay. Please turn to Slide 15.

As you have seen, the development of Bylvay is advanced and is at various stages across the three indications. It's worth noting that competition is very limited with only one launch so far in Alagille syndrome. We have outlined here our broad assumptions for the numbers of patients across the indications.

On pricing, we assume a higher price in Alagille syndrome and then biliary atresia than in PFIC. Our assumption is that the overwhelming majority of patients will stay on treatment until they need a liver transplant. The time to liver transplant is dependent on the native liver survival rate per indication and per response to the treatment. Please turn to Slide 16.

Pulling this together means that we have substantial commercial opportunities to increase the sales of Bylvay. A strong Bylvay efficacy and safety profile has been established, and there are very limited number of competitors in this space. It is leading in PFIC and biliary atresia, where competition is in Phase 2. Bylvay is already on the market in the U.S. and in Europe for PFIC and already been launched and reimbursed in a number of countries including in the U.S. where favorable coverage has been secured as well as nine9 countries in Europe.

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Company Name: Ipsen SA Company Ticker: IPN FP Equity Date: 2023-01-09

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The profile of Bylvay has been augmented by compelling results from the ASSERT trial for Alagille syndrome, and regulatory submissions were made in the U.S. and EU late last year. So we would expect regulatory decision in this indication at the end of 2023.

Global rights in the hands of a truly global company mean that we can leverage our infrastructure, capabilities and strength to fully accelerate the sales of Bylvay. It's also worth highlighting the convenient dosing with food via capsules once a day, which are preferred by children and teens. Bylvay can be sprinkled over food via oral pellets for babies.

Finally, we have a good patent life in both U.S. and in Europe. With success in all three indications, we can deliver peak sales of around $800 million, of which approximately half would come from biliary atresia.

I'll now hand you over to Aymeric, who will summarize the financials. Please turn to Slide 17.

**Aymeric Le Chatelier** {BIO 18911728 }

Thanks, David. Please turn to Slide 18. The terms of the agreement include an offer to acquire all outstanding shares of Albireo for $42 per share in cash at closing, which will represent an initial consideration slightly in excess of $950 million.

The agreement has been structured to include a contingent-value payment based on the approval of Bylvay in biliary atresia in the U.S. by FDA. One contingent-value right per share will entitle its holder to a deferred cash payment of $10 per CVR, which will represent about $240 million. As you can see, this transaction will be fully financed by our existing available cash and line of credit. And we will keep, after the transaction, sufficient firepower to continue our business development strategy.

Subject to the satisfaction of all closing condition, including regulatory, we anticipate the closing of the transaction by the end of this quarter. The acquisition of Albireo will immediately provide incremental sales. And we anticipate short-term revision to our profitability until the end of next year. It's very similar to the Epizyme acquisition. From 2025, we expect accretion to our core operating income.

So as you can see, this financial profile is consistent with our outlook to do this and make operating investment under the external innovation strategy to promote the long-term and sustainable growth of Ipsen.

I will now hand over back to David. Please turn to Slide 19.

**David Loew** {BIO 18056474 }

Thank you, Aymeric. I'd now like to conclude our presentation before we go to your questions. Please turn to Slide 20.

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Company Name: Ipsen SA Company Ticker: IPN FP Equity Date: 2023-01-09

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As we make more progress with the execution of our external innovation strategy, I'm pleased to announce today's news. It's another step in our journey of delivering sustainable growth over the long term and supporting excellent medicines to get to more patients. We're expanding the scope of our rare disease business by acquiring a leading innovator in bile-acid modulators for rare liver diseases with real expertise in bile-acid modulation.

In Bylvay, we'll have an on-market and potentially best-in-class medicine that has an advanced development program and significant commercial opportunities. Finally, it is an excellent fit for Ipsen in line with the consistent strategy for growth. Please turn to Slide 21.

Thanks for listening to our presentation. We now have time for questions. Operator, over to you.

**Questions And Answers** 

**Operator** 

(Question And Answer)

Ladies and gentlemen, we now begin the question-and-answer session. (Operator Instructions) We are now taking the first question. The first question from Jo Walton from Credit Suisse. Please go ahead. Your line is open.

**Q - Jo Walton** {BIO 1541280 }

Thank you very much. I think, the main question that people have is why you are able to get something with peak sales potential of around $800 million for something in the region of $1 billion. Normally, you seem to pay a much higher multiple of potential peak sales. I wonder, if there is something unusual in the profitability that we can't see from looking at consensus forecasts, that would take the profitability down. Secondly, I note from the company is that their guidance was for $24 million of sales for this year. They've already done around $18 million or so. So, there's only $6 million left, which is less than the third quarter.

Now, they did make a comment that sales would go down because we're beyond the end of the German free pricing period. So perhaps you could tell us a little bit about how you see pricing developing in Europe? And for our modeling, I wonder if you can help us on what sort of avoidance of interest charge? I mean, given that you've got cash or what sort of interest rate we should put against this, and whether you are able or intending to get rid of the so-called partners health royalty program, presumably you can just buy that out and add that to the initial cost? Many thanks.

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Company Name: Ipsen SA Company Ticker: IPN FP Equity Date: 2023-01-09

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**A - David Loew** {BIO 18056474 }

Thank you, Jo. So on the $800 million, you have seen that actually there were already analyst reports which were much higher. We actually came to the conclusion that with the $800 million that is the right price or the right figure for peak sales, which I think we're going to achieve in 2029-ish, 2030-ish. So now I can't really, comment on the multiples of the market, of course that the market has taken a hit on biotech and so it's really something that we were also, not quite sure, how it is explained, but I think we made a fair offer. And with 100% premium, I think that's a very fair premium so that's all I can say on this point. Regarding the sales, I think we need to see the official results, that Albireo is going to publish.

So, I think they have been doing quite nicely in terms of the pricing in Europe, we don't think next to this effect that we have mentioned on German there are other FX, of course the pricing in Europe is somewhat lower than in the U.S. as usual. But there is, special no explanations or watch the space for the Q4 sales. In terms of the modeling, I will hand over to Aymeric.

**A - Aymeric Le Chatelier** {BIO 18911728 }

Yeah. So maybe back a little bit to your question about the profitability. So I think it's a rare disease accompany, so there is nothing specific that will impair the profitability. There is no specific way until the cost of goods are pretty standard and pretty low. So, clearly, you were asking the question about the royalty debt financing. As you can see, there is a possibility to potentially buy this out, and that will reduce clearly the level of royalties which are not actually in that amount. So, today the dilution is assuming, we're going to find a way to buy out this royalty debt.

Regarding the financing, we have a revolving credit facility that has been set up a couple of years ago, which is a very favorable interest rate in terms of margins. So this shouldn't be a very huge cost of financing for us, and we also have available cash. So the transaction is going to be financed with a combination of our existing cash and some drawing on our revolving credit facility. Last one, maybe on the guidance of the company, I think the company has been quite conservative, given the track record since the beginning of the year. So I won't assume that the fourth quarter is going to be lower than the previous one. And this was a guidance provided in October on the 24 million debt.

We'll provide more when we close our books in February.

**A - Craig Marks** {BIO 17697576 }

Operator, can I just check, we've had a couple of people say they couldn't hear the first part of David's answer. Can I just check if you are able to hear that?

**Operator** 

Yes, I was sir. Thank you.

**A - Craig Marks** {BIO 17697576 }

Thank you.

**A - David Loew** {BIO 18056474 }

And Jo you've got the answer to your questions? Did you --

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Company Name: Ipsen SA Company Ticker: IPN FP Equity Date: 2023-01-09

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**Q - Jo Walton** {BIO 1541280 }

Yes, I think I got all the answers. But I do know that some people who are on the webcast are finding it more difficult than those of us who have dialed in.

**A - Craig Marks** {BIO 17697576 }

Okay, interesting. So, it seems to be linked to the webcast. So perhaps, if people on the webcast have difficulties, please dial in through the phone. Okay, operator next question. Thank you. Jo.

**Operator** 

We are now taking the next question. Please stand-by. The next question from Michael Leuchten from UBS. Please go ahead. Your line is open.

**Q - Michael Leuchten** {BIO 6288320 }

Thank you very much. It is Michael Leuchten from UBS. Three questions please. I'm just going back Aymeric to your comments around sort of the operating expenses, efficiencies and then margin accretion. Given that you have Palovarotene infrastructure sitting there with somewhat of an uncertain future until we exactly know what's happening with the FDA. Like how much of the cost that you're taking on will you be able to absorb or is there a scenario where you have to keep both your and the other be rail infrastructure in place until you get more clarity and at that point, it might actually be more efficiencies that allow you to get a better margin accretion then in maybe in the first two years So, how are you going to absorb or not the OpEx both in terms of SG&A and R&D, that you're taking on with this transaction.

The second question just wondering, how you think about the competition? You did mention Livmarli and — product that's out there Alagille. So, as they now at some point get their Phase III readout, how do you think competition is going to shape up in PFIC and just any thoughts would be helpful. And then, is there any timeline to the CVR? Is there any sort of point in time where the CVR expires regardless of what happens with the approval or is it open-ended? Thank you.

**A - Aymeric Le Chatelier** {BIO 18911728 }

So maybe to start your question on the OpEx and the Palovarotene, I mean, as you know - I mean, on the R&D side, there will be very, very limited synergies. These are very different study to be read, and by the way is not that much left for Palovarotene. So I think your question is more on the SG&A. And clearly we are building a rare disease infrastructure. It's quite limited as we don't need a lot in this ultra-rare space. So, yes, if we were to launch both Palovarotene and Bylvay, we may have some limited synergy, but that's a major driver today of the cost base. And we believe that there is the right investments behind Bylvay. We need more of the sales to ramp-up, and dilution is really coming from a progressive ramp up. We expect by the end of this year to get the second indication. And then to progressively ramp-up on these two indications, and R&D is going to be mainly related to the BA study.

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Company Name: Ipsen SA Company Ticker: IPN FP Equity Date: 2023-01-09

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**A - David Loew** {BIO 18056474 }

On your second question, Michael on the competition, so basically Livmarli is already registered in Alagille, we are going to come on the market towards the end of the year. They have shown positive results also in PFIC, it's really hard to compare across studies, and so we see the profile as pretty similar regarding efficacy. Perhaps, there is a safety advantage for Bylvay, but it's very, very hard to say because, there is less diarrhea, but this is across a comparison of very low numbers of patients. So one needs to be super careful when looking at cross study comparisons.

What I can say is where we do see a differentiation is clearly on the dosing. So Bylvay has capsules and pellets, when you need to give a dose to a baby or to a toddler, sometimes it can be hard for those of you who have babies or toddlers and so the dosing on Bylvay is actually very convenient. So, if you have a baby, you can sprinkle the pellets over for example, an apple sauce or a chocolate pudding and the babies usually like that. And then once they grow a bit older and they can start to swallow, then they can take the capsules which in this market is, I think very important because, this market can go up to teenagers and also some adolescents.

So, having a capsule, I think, is something which we really liked. Then, another important point is on BA, which is about 50% of the forecast. Clearly, Build A has a strong head start, being in very advanced Phase III, while competition is in Phase II and if measuring on a surrogate end point. So, all in all this is what actually seduced us on Albireo. Then on the CVR and the exploration I hand over to Aymeric.

**A - Aymeric Le Chatelier** {BIO 18911728 }

Yeah, so as you can see, from the press release, the drop date for the CVR is end of December of 2027, as we have room to potentially adjust the number of patients in the — study and that so what explains that is the way to maximize the probability of success of that study, which represents a large part of 50% of the 800 million B-cell.

**Q - Michael Leuchten** {BIO 6288320 }

Thank you.

**A - Craig Marks** {BIO 17697576 }

Operator, our next question?

**Operator** 

Yes. We are now taking the next question. The next question from Simon Baker from Redburn. Please go ahead. Your line is open.

**Q - Simon Baker** {BIO 20973508 }

Thanks for taking my questions. A few quick ones, if I may, on Bylvay, just kind of back to Jo's question about royalties, but specifically on Bylvay, there have been quite a few deals done regionally in the U.S., Israel, Turkey, The Gulf, Japan. So, I just wondered if you could give us a summary of where those deals stand in terms of what is that you will paying away in any key territories on Bylvay.

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Company Name: Ipsen SA Company Ticker: IPN FP Equity Date: 2023-01-09

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And then a second one, a number of other IBAT inhibitors are being tried in PBC. Bylvay doesn't appear to be in PBC at moment. I just want to know if that is an additional opportunity. And then second and final question, you haven't talked about Elobixibat, which I think is only approved in Japan and Thailand. I just wondered if you could give us your thoughts on the commercial potential of that as well. Thanks so much.

**A - David Loew** {BIO 18056474 }

Thank you. So on the royalties, I think we can have Aymeric elaborate on that.

**A - Aymeric Le Chatelier** {BIO 18911728 }

Yeah. I think that there is only a back-to-back agreement on Japan, and this has no impact for us. There has been transaction, which we don't intend to change, contrary to the big royalty financing that was set up by Albireo in September. So clearly, Japan is not in the scope, and that's the only territory assuming we payout the segment of royalty financing that will exist, and this will have no impact, and this is totally back-to-back. Then on the IBAT using PBC, Howard, you want to elaborate on this?

**A - Howard Mayer** {BIO 20100424 }

Yes. So, we're aware that other IBAT inhibitors are being tried for pruritus in primary biliary cholangitis. Right, currently there's no such program for Bylvay, however, there is an order oral systemic, IBAT inhibitor in the pipeline from Albireo called A3907 that has the potential to be used in adult cholestatic liver diseases currently PSC, but potentially others. So that's, that's the situation with the pipeline as it stands today.

**A - David Loew** {BIO 18056474 }

Thank you, Howard. And then on your third question on Elobixibat. So, the acquisition includes all of Albireo marketed products and pipeline assets and EA Pharma is the exclusive licensee of Elobixibat for the treatment of gastrointestinal disorders in Japan and other select countries in Asia, but not including China. Albireo currently has own commercial rights to Elobixibat in the United States, Europe and China and otherwise outside of the territories like to EA Pharma. And we are currently assessing all of our opportunities across the whole of Albireo portfolio, both marketed and pipeline.

**Q - Michael Leuchten** {BIO 6288320 }

Thank you very much.

**A - Craig Marks** {BIO 17697576 }

Next question.

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Company Name: Ipsen SA Company Ticker: IPN FP Equity Date: 2023-01-09

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**Operator** 

Yes, sir. We are now taking the next question. The next question from Rosie Turner from Jefferies. Please go ahead. Your line is open.

**Q - Rosie Turner** {BIO 15408955 }

Hi, thanks very much for taking my questions. Just a few quick ones left, if I may. So may be continuing on, in terms of the broader pipeline, I think there's A3907, if that's the correct way to say it. It's like that was going into Phase II in 2022. But I can't see an update on the website. Has that happened and is that kind of still planned to go into Phase II kind of under Ipsen ownership. And kind of going a little bit back to the royalty question, so does that mean that all opportunities kind of ex-Japan for kind of additional sales thinking about kind of China, et cetera? And then just finally, say the CVR, do we know is that going to be tradable or is that going to be something that's OTC? Thank you.

**A - David Loew** {BIO 18056474 }

Okay. So perhaps we started with A3907, it indeed have just started the Phase II. I'll let Howard elaborate on this one.

**A - Howard Mayer** {BIO 20100424 }

Yes, A3907, if you look on clinicaltrials.gov, it is public information that it has started a Phase II study with two doses in patients with primary sclerosing cholangitis. So that has actually been posted, and my — our understanding is they're imminently going to start that study.

**A - David Loew** {BIO 18056474 }

On the question two, so we do have the rights for Bylvay in China, and we anticipate that they could probably come on the market in 2026 there. So, I wasn't quite sure about your question because you are asked on royalties and then China, but and so we don't have Japan.

**Q - Rosie Turner** {BIO 15408955 }

Don't have Japan. Yes.

**A - David Loew** {BIO 18056474 }

Yes. We don't, we don't have Japan as you know. But, we do have China. So, perhaps you can quickly clarify your question.

**Q - Rosie Turner** {BIO 15408955 }

Yes, no. That's perfect. That answers my question. Yes, was just checking.

**A - David Loew** {BIO 18056474 }

Okay.

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Company Name: Ipsen SA Company Ticker: IPN FP Equity Date: 2023-01-09

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**Q - Rosie Turner** {BIO 15408955 }

Are there any other opportunities where you don't have royalty payments? So yes —

**A - David Loew** {BIO 18056474 }

Yes.

**Q - Rosie Turner** {BIO 15408955 }

So, I guess it would obviously be China. It sounds like it is too basic.

**A - David Loew** {BIO 18056474 }

Yes the answer is yes. Okay. And then on the CVR tradable I will give it to Aymeric.

**A - Aymeric Le Chatelier** {BIO 18911728 }

No. The answer is no. The CVR is not going to be tradable.

**Q - Rosie Turner** {BIO 15408955 }

Thank you.

**A - Craig Marks** {BIO 17697576 }

Thank you. Operator, next question.

**Operator** 

Thank you for your question. We are now taking the next question from the line of Charles Pitman from Barclays. Please go ahead. Your line is open.

**Q - Charles Pitman** {BIO 1646224 }

Hi. Thanks very much for taking my questions. Charles Pitman from Barclays. Just a few questions for me. Personally, just on the kind of strength of IP, could you give us a little bit more detail around the strengths you are on, and IP for Bylvay given the footnote on — in your slide suggests that you're currently projects out to November, 2031, but then based on patent term extensions, a lot will extend to Phase III studies, so can you just give an idea of the kind of confidence you have on those extensions. And then this is on kind of your M&A strategy.

This is naturally a more de-risked acquisition already being on the market. Is this a kind of strategic change in your strategy going forward and can you just talk a bit more around the reasoning for ensuring the CVR linked just to the approval of BA, whilst it's expected to be 50% of your peak sales, and then just a quick clarification question, during — I think you said it was 50% of patients require a liver transplant in the first two years, but in the appendix it says 80%. Can you just clarify which of these is the correct amount? Thanks.

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**A - David Loew** {BIO 18056474 }

Okay. So on the IPS, we are comfortable on the IP, so exploration in the U.S. will be end of '23 is our read — and then end '33 — sorry '33 I want to say, end of '33, sorry for that. For the U.S. and for Europe, the loss of exclusivity is, end '35, we're going to use second question on the CVR, with BA I hand over to Aymeric.

**A - Aymeric Le Chatelier** {BIO 18911728 }

Yeah, I think your question is, yes this transaction is partly derisked because as you can see, BA is a significant part and there is still a Phase 3. And we saw that was the appropriate way of structuring the deal. I think as you can see, timing also of BA may take a little bit longer than what was anticipated. So that's why, we still choose a deal to be derisked. And that's the way we intend to continue our M&A strategy. That's the way we did it also for Epizyme. And as you know, the Elafibranor transaction was also a - it was a licensing agreements, where we pay a limited approach. So, I think it's very consistent on our M&A strategy.

**A - Craig Marks** {BIO 17697576 }

And Operator, could I just confirm, we just had a couple of people saying they couldn't hear. Can I just confirm, if you can hear.

**Operator** 

Yes, sir. I can hear you loud and clear.

**A - Craig Marks** {BIO 17697576 }

Okay. Thank you.

**A - David Loew** {BIO 18056474 }

Okay. And then on the third question regarding native liver transplant survival, I hand over to Howard regarding the BA questions.

**A - Howard Mayer** {BIO 20100424 }

Yes. So the correct answer is that about 50% of patients who've undergone a Kasai procedure will require a liver transplant within the first two years of life. And with the least 80% requiring liver transplantation by age 20 years. So apologies, if that wasn't clear.

**Q - Charles Pitman** {BIO 1646224 }

Thank you very much.

**A - Craig Marks** {BIO 17697576 }

Operator. Next question.

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**Operator** 

Thank you for your question. We are now taking the next question. And the question for Richard Parkes from Exane BNP Paribas. Please go ahead, your line is open.

**Q - Richard Parkes** {BIO 3890492 }

Alright. Thank you very much for taking my questions. Firstly, this perception I think that may be out there, your did a good job in terms of development and in terms of commercial execution, I don't know whether that's correct or not, but just wondered if you feel, that's the case as well. And maybe understand how do you plan to improve on that and how things could have been done better so far.

Then, the second question for Howard, just wondered, if you could help us understand what a one to two point reduction in pruritus score means for a patient, just help us put that in context. It would be really helpful. And then finally, just a couple of minor things. Just wondered if you could help us understand what you've assumed in terms of market shares with the competitor in your $800 million potential.

I know you are not going to be specific there, but if you can help as broadly that would be helpful. And then thirdly, sorry just one more pricing. Could you just help us by confirming the current pricing and I think you've mentioned that you expected Alagille Syndrome pricing to be higher than the other indications, I don't know if I miss heard that. But just wondered why that might be, as the dosing is same across all the indications or is there some other difference there. Thank you very much.

**A - David Loew** {BIO 18056474 }

Okay. Regarding the commercial execution, I think, always when you have startup biotechs launching themselves. It's not necessarily the same performance than if you have a larger company who has been in a field, for example, in a rare disease, we had some acromegaly, we had — et cetera. So, we had kind of a very strong organization, it's not the same performance. So, we do indeed assume that we can get a stronger performance by throwing the full force of Ipsen globally behind the product, and that was also one of the reasons why this acquisition saw the light. Because the board also saw that this is an advantage for the drug and Albireo was very committed to patients and very purpose led. So are we and so therefore that is also a motivation for the acquisition.

Then on your second question. Howard, on the one to two points on pruritus what does it mean?

**A - Howard Mayer** {BIO 20100424 }

Yes. So, basically when you look at the precision scale that was used by Albireo for these programs, it's based on a zero to four scale with no itching versus the most severe itching, and a one-point change obviously, in a 4 point scale is significant and when you talk to key opinion leaders they consider a one-point change to be very clinically meaningful. So and as you know, many of these children have really debilitating pruritus where, there's blood on the bed sheets, et cetera, so — and it can really impact quality of life. So a one-point change is felt to be clinically meaningful.

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**A - David Loew** {BIO 18056474 }

Thank you, Howard. On your third question regarding market share, as you said, we're not guiding on a number. What I can say is that efficacy, if you look across any comparison, and as I said, you have to be very careful when doing that, but it looks broadly similar. We think, we have an advantage on the dosing. It is more convenient and there might also be a slight benefit on the side effect profile. But again, this cross study comparison, so we need to be extremely careful.

So having said that, we would assume obviously attractive market shares for Bylvay. Regarding pricing, your question was, is the price going up because of the dose, the answer is, yes. The dose registered in PFIC is 40 micrograms. It's potentially, now our GL is going to be 40 or 120. We have to see what comes out of the discussions with the FDA. We think it should be 120 on BA, it will also be 120. Now, of course you can't just multiply by three that price. That's not going to work. So we will have to take this into account, but we do assume a somewhat higher price in these two other indications. With this -

**Q - Richard Parkes** {BIO 3890492 }

One follow-up, could you just confirm what the current WAC pricing is in the U.S. and maybe what kind of average pricing in the other territories. Thank you.

**A - David Loew** {BIO 18056474 }

So it's super complex actually to give that because it's dose dependent. And if you give it to a baby, of course, is a much, much lower dose than if you give it to a seventeen-year- old, what we can help you in the modeling is to say in the U.S., if you take, an average price, we would estimate that, it's about $350,000. In the EU, the list prices are between $120,000 to $195,000 in average per year. So, but, of course that Europe you then have to deduct also net prices. So, there is a bit of a difference there.

**A - Craig Marks** {BIO 17697576 }

Thank you operator, next question.

**Operator** 

Yes, sir. We are now taking the next question. And the next question is from Holly from Royal Bank of Scotland. Please go ahead.

**Q - Alistair Campbell** {BIO 3485689 }

Hi. Alistair Campbell from Royal Bank of Canada. Just a couple of questions following up on Biliary Atresia, thanks. First of all, just looking at the BOLD study obviously, placebo arm you're probably expecting about 50 of those patients progress towards liver transplant. So, I'm kind of curious what sort of efficacy, you're hoping to see from BOLD. And if you did see a significant delay of liver transplant within the lifetime of the product in terms of its IP life, could you see that incidence rate, the U.S. or sort of prevalence rate in the U.S. is about 600, increase significantly. And ultimately you took a bigger sales number.

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Company Name: Ipsen SA Company Ticker: IPN FP Equity Date: 2023-01-09

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And the second question is again on BA, I was sort of reading some article this morning saying that incidents in Asia is I mean significantly higher than Europe, so multiples of Europe. So given that are there any sort of tell you how important in your forecast is Asia X, Japan or your forecast largely based on U.S. Europe. Thanks.

**A - David Loew** {BIO 18056474 }

Yeah, so very good questions. Thank you Alistair. Regarding the BOLD study, I perhaps hand over to Howard.

**A - Howard Mayer** {BIO 20100424 }

Yeah, so the BOLD study is statistically powered to show a minimum of 15% improvement in patients, who are treated with Bylvay, in addition to having a Kasai procedure versus the Kasai procedure alone. Obviously, it could be greater than that. And that would be great but it's basically minimally powered to show a 15% improvement in native liver survival at two years.

**A - David Loew** {BIO 18056474 }

Then is the prevalence going to, kind of accumulate over time. Of course, we do hope that there is an impact on the timing to liver transplant. So that this gets pushed out, and that would indeed mean that you have an accumulative effect on the prevalence pool. So, this is a very good question. Because the modeling is actually not easy on the three indications, I have to say. What we modeled is on PFIC that you have a small incidence pool of new babies, so it's 1 in 100,000s births. But there is, of course as you have seen on the slide with the prevalence, a bit of a larger pool on the prevalence. Now that prevalence pool is also going to start decreasing, and the incidence pool is going to start kind of fermenting the new prevalence pool.

Alagille is a bit of the same thing. So you have 3 in 100,000 and the prevalence figures you have seen also are quite significant already. Again, the prevalence pool of people already been in there today is going to start decreasing over time with the natural liver transplant survival curve. But of course, the new birth are going to replenish that pool. And then on BA it's going to be mostly driven by the incidence pool. You have also a prevalence pool but the ratio is a bit smaller as you have seen on our slide.

But then again over time if indeed we managed to prolong the time to transplant, that prevalence pool should increase over time. And then to your second, question on the BA incidence, it is higher in Asia and what are the rest of the world sales? We did a bottom- up forecast for China and the rest of the world sales that we have modeled are somewhat higher indeed than the European sales. But that is also often the case. So, we are not at the level of detail yet on our forecast model, having modeled, all the other Asian countries we have taken a kind of a multiplayer on the rest of the world there.

**A - Aymeric Le Chatelier** {BIO 18911728 }

But quite to be clear, I mean, the majority of the peak sales are really coming from the U.S., today it is not disproportion due to that potential upside due to the incidence prevalence in Asia.

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Company Name: Ipsen SA Company Ticker: IPN FP Equity Date: 2023-01-09

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**Q - Alistair Campbell** {BIO 3485689 }

Okay. Very good. Thank you.

**A - Craig Marks** {BIO 17697576 }

Next question, operator.

**Operator** 

We are now taking the next question. The next question from Delphine Le Louet from SEB. Please go ahead. Your line is open.

**Q - Delphine Le Louet** {BIO 3695503 }

Thank you. Happy New Year, everyone. I was wondering, who is going to be responsible for the manufacturing going forward, first question. Second question, we had roughly EUR80 million R&D spent over the past three years in the project, the pipeline. How should we consider that looking forward and especially the sequence, '23, '24, and then and particularly after that? Third question, a more clinical question. I was just wondering, if you have a cohort of 100 patients going for it, so regarding BA, going for a Kasai procedure, how many of them reached 20 years old? And how many of these 100 patient, let's say three years old having the Kasai are going to have a liver transplant in between two and 20 years old. Thank you very much.

**A - David Loew** {BIO 18056474 }

Okay. First on the manufacturing. So Albireo has contracted with very well-known CMOs, out of which one in France as well. And so on the manufacturing plants, we are very confident. There is no issue there. Regarding your second question on the clinical development, I hand over to Howard.

**A - Howard Mayer** {BIO 20100424 }

Sorry, the question around the Biliary Atresia and liver transplant incidence, just

**A - David Loew** {BIO 18056474 }

Yeah.

**Q - Delphine Le Louet** {BIO 3695503 }

Yes.

**A - Howard Mayer** {BIO 20100424 }

Okay. So basically the incidence of patients who have a Kasai procedure, requiring a liver transplant at — within the first two years of life is 50%, based on most recently available data. However, even the patients that basically are success — have a successful Kasai procedure, those patients tend to continue to have progressive disease. And so, at least 80% of those patients require liver transplantation by age 20 years, and of those patients who survived into the third decade after birth, almost all have portal hypertension or other complications of cirrhosis.

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Company Name: Ipsen SA Company Ticker: IPN FP Equity Date: 2023-01-09

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So, even those patients that actually have a liver transplant or have a successful Kasai and have a native liver survival, those patients tend to continue to progress, and 80% of those or more require liver transplant by age 20, and even of those patients continue to progress in terms of their liver disease. So that's why we think, there's really an urgent need for a pharmacological therapy to be available in addition to the Kasai procedure.

**A - David Loew** {BIO 18056474 }

And then yeah, and then on your third question, on the R&D expenditures, so that's Aymeric?

**A - Aymeric Le Chatelier** {BIO 18911728 }

Yeah. So the thing on the R&D, I'm not sure about the number you were talking about, but we spend about 15% of all sales in R&D. You should expect that ratio to significantly increase over time, when I say over time in 2023, even 12 on one side, the Epizyme R&D spend, which will come from both the clinical trials but also the early stage pipeline and we're going to add clearly the R&D spend of Albireo and mainly being the cost of the BA study that needs to be completed, and also some of the development of the more earlier stage assets.

So, this is very consistent with our overall outlook, where R&D is going to increase. This is going to be across '23 but also in '24, but then in '24, we're going to have more leverage from the sales, both from Epizyme and Albireo and leverage the infrastructure.

**Q - Delphine Le Louet** {BIO 3695503 }

Okay. But for the Phase III, IV BA, can we get an envelope, some of the cost?

**A - Aymeric Le Chatelier** {BIO 18911728 }

I think it's a classical Phase III, so the number of patient is not that high. So, I don't think it's very significant. This will be on top of the development of the other earlier stage asset also of the Albireo pipeline

**Q - Delphine Le Louet** {BIO 3695503 }

Okay. Thank you very much.

**A - David Loew** {BIO 18056474 }

Very good. Thank you, Delphine. Operator, next question. And that will be our last question.

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Company Name: Ipsen SA Company Ticker: IPN FP Equity Date: 2023-01-09

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**Operator** 

We'll now taking the next question. The next question from Jacob from Lars company. Please go ahead. Your line is open.

**Q - Analyst** 

Hi there, and thanks for taking my question. I just had one on. If you could elaborate on the side effects, experienced by patients on Bylvay and how they are managed.

**A - David Loew** {BIO 18056474 }

Howard you want to take the side effect questions on Bylvay, and how they are being managed? Howard?

**A - Howard Mayer** {BIO 20100424 }

Sorry, sorry, I was speaking into mute. So, basically the main side effects are gastrointestinal adverse reactions. And obviously those can be minimized with obviously the need to take it with food, with hydration as needed, but as David alluded to before, we actually think that there might be differences between the available IBAT inhibitors in terms of those types of side effects. Other side effects that are known are fat-soluble vitamin deficiency, which really occurs in a small number of patients and can be managed with adequate vitamin supplementation. So, we don't think that that is a major issue.

And in general, I would say, as I said in my presentation that most of the adverse events that are seen with Bylvay are mild to moderate and really don't result in discontinuation typically. So, we think this is a generally, well tolerated drug both in PFIC but also in the Alagille program, which was recently filed to the agencies.

**A - David Loew** {BIO 18056474 }

Very good. Thank you, Jacob. That was our last question. I would like to thank everybody for participating and I hand over to the operator.

**Operator** 

That concludes the conference for today. Thank you for participating. You may all disconnect.

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