Strategic Acquisition and Capital Elevating - Investor Presentation

“That is the primary approval for TEPEZZA in Asia and marks a major milestone for the worldwide remedy of TED,” stated Jay Bradner, M.D., government vice chairman, Analysis and Improvement, and chief scientific officer at Amgen. “Traditionally, sufferers with TED have been managed with complicated surgical procedures and high-dose steroids, which may trigger additional issues. With TEPEZZA, docs have a nonsurgical and nonsteroidal choice that treats a root reason behind this debilitating illness.”

TEPEZZA acquired orphan drug designation in Japan , which supplied a nine-month regulatory assessment interval in comparison with the usual 12-month assessment. The approval was based mostly on the constructive outcomes of OPTIC-J ( jRCT2031210453 ), a Section 3 randomized, double-masked, placebo-controlled, parallel-group, multicenter research evaluating the efficacy, tolerability and security of TEPEZZA within the remedy of sufferers with energetic TED in Japan .

The first endpoint within the trial was met, as 89% of sufferers handled with TEPEZZA had a clinically significant enchancment in proptosis (≥2 mm) in contrast with placebo (11%; p 3 A second Section 3 medical trial is ongoing in Japan evaluating TEPEZZA amongst adults with power TED and a low CAS ( jRCT2031220730 ).

“Folks residing with energetic TED can expertise a major burden of illness with signs that may make each day life troublesome to navigate,” stated Yuji Hiromatsu , M.D., a professor emeritus on the Kurume College Medical Middle and doctor on the Diabetes, Thyroid and Endocrine Middle on the Shin-Koga Hospital. “The approval of TEPEZZA in Japan is a vital development for sufferers and affords a brand new remedy choice that targets the underlying mechanism of the illness.”

Along with Japan , TEPEZZA is at the moment accepted within the United States, Brazil and the Kingdom of Saudi Arabia, and is underneath regulatory assessment in Europe , Canada and Australia .

About Thyroid Eye Illness (TED)
TED is a critical, progressive, debilitating and doubtlessly vision-threatening uncommon autoimmune illness. ⁴ It usually happens in individuals residing with Graves’ illness, however is a definite illness that’s brought on by autoantibodies activating an insulin-like progress factor-1 receptor (IGF-1R)-mediated signaling complicated on cells inside the retro-orbital area. ⁵^,⁶ This results in a cascade of detrimental results, which can trigger long-term, irreversible injury, together with blindness. ⁷^,⁸ Indicators and signs of TED might embrace dry eyes and grittiness; redness, swelling and extreme tearing; eyelid retraction; proptosis; stress and/or ache behind the eyes; and diplopia.

Necessary Japan Product info

PRODUCT NAME	TEPEZZA ^® for Intravenous Infusion 500 mg
Generic Identify (JAN)	Teprotumumab (Genetical Recombination)
Indication	Energetic thyroid eye illness
Precautions associated to indications	Listening to problems (e.g., deafness, hypoacusis, Eustachian tube dysfunction, patulous Eustachian tube, hyperacusis, tinnitus, and tympanic membrane dysfunction) might happen throughout remedy with TEPEZZA, and critical and irreversible occasions have additionally been reported. Sufferers eligible for TEPEZZA remedy must be chosen based mostly on a radical understanding of the knowledge supplied in “17. Scientific Outcomes,” the backgrounds of the sufferers within the medical research, and the outcomes of the research of the efficacy and security of TEPEZZA. Scientific research of the efficacy and security in sufferers with gentle energetic thyroid eye illness haven’t been performed.
Dose and Administration	The same old grownup dosage is 10 mg/kg as teprotumumab (genetical recombination) for the primary dose and 20 mg/kg for the second and subsequent doses, administered intravenously each 3 weeks, for a complete of 8 infusions.

About TEPEZZA ^® (teprotumumab-trbw) within the U.S.

U.S. INDICATION

TEPEZZA ^® is indicated for the remedy of Thyroid Eye Illness no matter Thyroid Eye Illness exercise or length.

U.S. IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Infusion Reactions: TEPEZZA might trigger infusion reactions. Infusion reactions have been reported in roughly 4% of sufferers handled with TEPEZZA. Reported infusion reactions have often been gentle or average in severity. Indicators and signs might embrace transient will increase in blood stress, feeling scorching, tachycardia, dyspnea, headache, and muscular ache. Infusion reactions might happen throughout an infusion or inside 1.5 hours after an infusion. In sufferers who expertise an infusion response, consideration must be given to premedicating with an antihistamine, antipyretic, or corticosteroid and/or administering all subsequent infusions at a slower infusion fee.

Preexisting Inflammatory Bowel Illness: TEPEZZA might trigger an exacerbation of preexisting inflammatory bowel illness (IBD). Monitor sufferers with IBD for flare of illness. If IBD exacerbation is suspected, think about discontinuation of TEPEZZA.

Hyperglycemia: Elevated blood glucose or hyperglycemia might happen in sufferers handled with TEPEZZA. In medical trials, 10% of sufferers (two-thirds of whom had preexisting diabetes or impaired glucose tolerance) skilled hyperglycemia. Hyperglycemic occasions must be managed with medicines for glycemic management, if vital. Assess sufferers for elevated blood glucose and signs of hyperglycemia previous to infusion and proceed to observe whereas on remedy with TEPEZZA. Guarantee sufferers with hyperglycemia or preexisting diabetes are underneath applicable glycemic management earlier than and whereas receiving TEPEZZA.

Listening to Impairment Together with Listening to Loss: TEPEZZA might trigger extreme listening to impairment together with listening to loss, which in some circumstances could also be everlasting. Assess sufferers’ listening to earlier than, throughout, and after remedy with TEPEZZA and think about the benefit-risk of remedy with sufferers.

ADVERSE REACTIONS

The commonest antagonistic reactions (incidence ≥5% and higher than placebo) are muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, listening to impairment, dysgeusia, headache, dry pores and skin, weight decreased, nail problems, and menstrual problems.

Please click on right here for Full TEPEZZA U.S. Prescribing Info.

About Amgen
Amgen discovers, develops, manufactures and delivers revolutionary medicines to assist thousands and thousands of sufferers of their combat towards a number of the world’s hardest ailments. Greater than 40 years in the past, Amgen helped to ascertain the biotechnology business and stays on the cutting-edge of innovation, utilizing expertise and human genetic information to push past what’s recognized immediately. Amgen is advancing a broad and deep pipeline that builds on its current portfolio of medicines to deal with most cancers, coronary heart illness, osteoporosis, inflammatory ailments and uncommon ailments.

In 2024, Amgen was named one of many “World’s Most Progressive Firms” by Quick Firm and one in all “America’s Finest Giant Employers” by Forbes, amongst different exterior recognitions . Amgen is without doubt one of the 30 corporations that comprise the Dow Jones Industrial Common ^® , and it is usually a part of the Nasdaq-100 Index ^® , which incorporates the most important and most revolutionary non-financial corporations listed on the Nasdaq Inventory Market based mostly on market capitalization.

For extra info, go to Amgen.com and comply with Amgen on X , LinkedIn , Instagram , TikTok , YouTube and Threads .

Amgen Ahead-Wanting Statements
This information launch incorporates forward-looking statements which are based mostly on the present expectations and beliefs of Amgen. All statements, apart from statements of historic reality, are statements that may very well be deemed forward-looking statements, together with any statements on the end result, advantages and synergies of collaborations, or potential collaborations, with every other firm (together with BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the efficiency of Otezla® (apremilast) (together with anticipated Otezla gross sales progress and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (together with the possible efficiency and outlook of Horizon’s enterprise, efficiency and alternatives, any potential strategic advantages, synergies or alternatives anticipated on account of such acquisition, and any projected impacts from the Horizon acquisition on our acquisition-related bills going ahead), in addition to estimates of revenues, working margins, capital expenditures, money, different monetary metrics, anticipated authorized, arbitration, political, regulatory or medical outcomes or practices, buyer and prescriber patterns or practices, reimbursement actions and outcomes, results of pandemics or different widespread well being issues on our enterprise, outcomes, progress, and different such estimates and outcomes. Ahead-looking statements contain important dangers and uncertainties, together with these mentioned beneath and extra absolutely described within the Securities and Trade Fee stories filed by Amgen, together with our most up-to-date annual report on Type 10-Okay and any subsequent periodic stories on Type 10-Q and present stories on Type 8-Okay. Until in any other case famous, Amgen is offering this info as of the date of this information launch and doesn’t undertake any obligation to replace any forward-looking statements contained on this doc on account of new info, future occasions or in any other case.

No forward-looking assertion might be assured and precise outcomes might differ materially from these we venture. Discovery or identification of latest product candidates or improvement of latest indications for current merchandise can’t be assured and motion from idea to product is unsure; consequently, there might be no assure that any specific product candidate or improvement of a brand new indication for an current product can be profitable and turn out to be a business product. Additional, preclinical outcomes don’t assure protected and efficient efficiency of product candidates in people. The complexity of the human physique can’t be completely, or generally, even adequately modeled by pc or cell tradition techniques or animal fashions. The size of time that it takes for us to finish medical trials and procure regulatory approval for product advertising has previously various and we anticipate related variability sooner or later.

Even when medical trials are profitable, regulatory authorities might query the sufficiency for approval of the trial endpoints we’ve chosen. We develop product candidates internally and thru licensing collaborations, partnerships and joint ventures. Product candidates which are derived from relationships could also be topic to disputes between the events or might show to be not as efficient or as protected as we might have believed on the time of getting into into such relationship. Additionally, we or others might establish security, unintended effects or manufacturing issues with our merchandise, together with our units, after they’re in the marketplace.

Our outcomes could also be affected by our capability to efficiently market each new and current merchandise domestically and internationally, medical and regulatory developments involving present and future merchandise, gross sales progress of not too long ago launched merchandise, competitors from different merchandise together with biosimilars, difficulties or delays in manufacturing our merchandise and world financial circumstances. As well as, gross sales of our merchandise are affected by pricing stress, political and public scrutiny and reimbursement insurance policies imposed by third-party payers, together with governments, personal insurance coverage and managed care suppliers and could also be affected by regulatory, medical and guideline developments and home and worldwide developments towards managed care and healthcare value containment. Moreover, our analysis, testing, pricing, advertising and different operations are topic to intensive regulation by home and international authorities regulatory authorities. Our enterprise could also be impacted by authorities investigations, litigation and product legal responsibility claims. As well as, our enterprise could also be impacted by the adoption of latest tax laws or publicity to extra tax liabilities. If we fail to fulfill the compliance obligations within the company integrity settlement between us and the U.S. authorities, we might turn out to be topic to important sanctions. Additional, whereas we routinely acquire patents for our merchandise and expertise, the safety provided by our patents and patent functions could also be challenged, invalidated or circumvented by our opponents, or we might fail to prevail in current and future mental property litigation. We carry out a considerable quantity of our business manufacturing actions at just a few key services, together with in Puerto Rico , and likewise rely on third events for a portion of our manufacturing actions, and limits on provide might constrain gross sales of sure of our present merchandise and product candidate improvement. An outbreak of illness or related public well being menace, resembling COVID-19, and the general public and governmental effort to mitigate towards the unfold of such illness, might have a major antagonistic impact on the provision of supplies for our manufacturing actions, the distribution of our merchandise, the commercialization of our product candidates, and our medical trial operations, and any such occasions might have a fabric antagonistic impact on our product improvement, product gross sales, enterprise and outcomes of operations. We depend on collaborations with third events for the event of a few of our product candidates and for the commercialization and gross sales of a few of our business merchandise. As well as, we compete with different corporations with respect to a lot of our marketed merchandise in addition to for the invention and improvement of latest merchandise. Additional, some uncooked supplies, medical units and element components for our merchandise are equipped by sole third-party suppliers. Sure of our distributors, clients and payers have substantial buying leverage of their dealings with us. The invention of serious issues with a product much like one in all our merchandise that implicate a whole class of merchandise might have a fabric antagonistic impact on gross sales of the affected merchandise and on our enterprise and outcomes of operations. Our efforts to collaborate with or purchase different corporations, merchandise or expertise, and to combine the operations of corporations or to help the merchandise or expertise we’ve acquired, might not be profitable. There might be no assure that we will understand any of the strategic advantages, synergies or alternatives arising from the Horizon acquisition, and such advantages, synergies or alternatives might take longer to understand than anticipated. We might not be capable of efficiently combine Horizon, and such integration might take longer, be harder or value greater than anticipated. A breakdown, cyberattack or info safety breach of our info expertise techniques might compromise the confidentiality, integrity and availability of our techniques and our information. Our inventory worth is risky and could also be affected by a variety of occasions. Our enterprise and operations could also be negatively affected by the failure, or perceived failure, of reaching our environmental, social and governance aims. The consequences of worldwide local weather change and associated pure disasters might negatively have an effect on our enterprise and operations. International financial circumstances might enlarge sure dangers that have an effect on our enterprise. Our enterprise efficiency might have an effect on or restrict the power of our Board of Administrators to declare a dividend or our capability to pay a dividend or repurchase our frequent inventory. We might not be capable of entry the capital and credit score markets on phrases which are favorable to us, or in any respect.

CONTACT: Amgen, Thousand Oaks
Madison Howard , 773-636-4910 (media)
Elissa Snook , 609-251-1407 (media)
Justin Claeys , 805-313-9775 (buyers)

References

Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab for thyroid-associated ophthalmopathy. N Engl J Med. 2017;376(18):1748-1761.
Natsuko W et al. J Endocr Soc. 2023 Nov 27;8(1):bvad148.
Yuji Hiromatsu , et al. “Efficacy and Security of Teprotumumab in Japanese Sufferers with Energetic Thyroid Eye Illness.” The 66th Annual Assembly of the Japan Thyroid Affiliation, December 9, 2023 . Summary No.O13-5.
Barrio-Barrio J, et al. Graves’ Ophthalmopathy: VISA versus EUGOGO Classification, Evaluation, and Administration. Journal of Ophthalmopathy . 2015;2015:249125.
Weightman DR, et al. Autoantibodies to IGF-1 Binding Websites in Thyroid Related Ophthalmopathy. Autoimmunity . 1993;16(4):251–257.
Pritchard J, et al. Immunoglobulin Activation of T Cell Chemoattractant Expression in Fibroblasts from Sufferers with Graves’ Illness Is Mediated By the Insulin-Like Progress Issue 1 Receptor Pathway. J Immunol . 2003;170:6348-6354.
McKeag D, et al. Scientific options of dysthyroid optic neuropathy: a European Group on Graves’ Orbitopathy (EUGOGO) survey. Br J Ophthalmol . 2007;91:455-458.
Bartalena L, Kahaly GJ, Baldeschi L, et al. The 2021 European Group on Graves’ Orbitopathy (EUGOGO) Scientific Follow Pointers for the Medical Administration of Graves’ Orbitopathy. Eur J Endocrinol . 2021.