00-0000000 false 0001936258 0001936258 2024-11-20 2024-11-20 0001936258 us-gaap:CommonStockMember 2024-11-20 2024-11-20 0001936258 us-gaap:WarrantMember 2024-11-20 2024-11-20
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 20, 2024
NewAmsterdam Pharma Company N.V.
(Exact name of registrant as specified in its charter)
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The Netherlands |
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001-41562 |
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N/A |
(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(I.R.S. Employer Identification No.) |
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Gooimeer 2-35 |
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Naarden |
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The Netherlands |
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1411 DC |
(Address of principal executive offices) |
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(Zip Code) |
+31 (0) 35 206 2971
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ |
Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ |
Pre-commencements communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbols |
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Name of each exchange on which registered |
Ordinary Shares, nominal value €0.12 per share |
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NAMS |
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The Nasdaq Stock Market LLC |
Warrants to purchase Ordinary Shares |
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NAMSW |
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The Nasdaq Stock Market LLC |
☒ Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. |
Item 7.01 |
Regulation FD Disclosure. |
On November 20, 2024, NewAmsterdam Pharma Company N.V. (the “Company”) issued a press release announcing positive topline data from its Phase 3 TANDEM clinical trial evaluating the fixed-dose combination of obicetrapib 10 mg and ezetimibe 10 mg in adult patients with heterozygous familial hypercholesterolemia (“HeFH”) and/or atherosclerotic cardiovascular disease (“ASCVD”) or multiple ASCVD risk factors, whose low-density lipoprotein cholesterol (“LDL-C”) is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The Company is hosting a live webcast and conference call to discuss the positive topline results of the TANDEM clinical trial on November 20, 2024 at 8:00 a.m., Eastern Time, and a live webcast of the call will be available through the Company’s website. A copy of the slide presentation to be used by the Company during the conference call is attached hereto as Exhibit 99.2 and incorporated herein by reference.
The information contained in this Item 7.01, including Exhibits 99.1 and 99.2, is being “furnished” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in this Item 7.01, including Exhibits 99.1 and 99.2, shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act or into any filing or other document pursuant to the Exchange Act, except as otherwise expressly stated in any such filing.
On November 20, 2024, the Company announced topline data from its TANDEM clinical trial, a Phase 3, randomized, double-blind, four-arm, placebo-controlled multicenter study evaluating the effect of 10 mg obicetrapib and 10 mg ezetimibe as a fixed-dose combination on LDL-C levels, compared to both ezetimibe 10 mg and obicetrapib 10 mg monotherapy and to placebo. The co-primary endpoints were percent change from baseline in LDL-C of the fixed-dose combination compared to each monotherapy arm after 84 days and obicetrapib 10 mg compared to placebo after day 84. Secondary endpoints incorporated percent changes from baseline in other biomarkers, including lipoprotein(a), non-high-density lipoprotein cholesterol and apolipoprotein B.
The TANDEM trial met all co-primary endpoints, including the obicetrapib-ezetimibe fixed dose combination achieving an LS mean reduction of 48.6% (p < 0.0001) compared to placebo at day 84. The observed reductions in the other co-primary endpoints are summarized below.
LDL-C percentage change:
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Ezetimibe (n=101) |
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Obicetrapib (n=102) |
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Obicetrapib and Ezetimibe FDC (n=102) |
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Day 84 - from placebo |
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Mean % |
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-23.3 |
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-35.5 |
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-52.2 |
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Median % |
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-22.6 |
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-37.2 |
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-54.0 |
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LS mean % |
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-20.7 |
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-31.9 |
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-48.6 |
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Comparison to pbo |
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— |
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(p<0.0001) |
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(p<0.0001) |
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Comparison to eze 10 mg |
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— |
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— |
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(p<0.0001) |
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Comparison to obi 10 mg |
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— |
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— |
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(p=0.0007) |
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We also observed reductions in lipoprotein(a), with mean observed reduction compared of placebo of 16.2% in the ezetimibe monotherapy arm, 56.2% in the obicetrapib monotherapy arm and 62.9% in the fixed-dose combination arm.
Over 60% of patients in the fixed-dose combination group saw a greater than 50% decrease in LDL-C levels. In the fixed-dose combination group, approximately 71%, 80% and 90% of patients achieved LDL-C levels of less than 55 mg/dl, 70 mg/dl and 100 mg dl, respectively. Similar LDL-C levels were achieved by approximately 41%, 60% and 88% of patients in the obicetrapib 10 mg group, respectively, approximately 25%, 56% and 80% of patients in the ezetimibe group, respectively, and approximately 7%, 18% and 64% of patients in the placebo group, respectively.
In the trial, the fixed-dose combination of obicetrapib and ezetimibe was observed to be well tolerated, with safety results comparable to placebo. The below table summarizes study drug-related treatment emergent adverse events (“TEAEs”) and study drug-related treatment emergent serious adverse events (“TESAEs”).
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Placebo (n=102) |
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Ezetimibe (n=101) |
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Obicetrapib (n=102) |
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Obicetrapib / Ezetimibe FDC (n=102) |
Any study drug-related TEAEs |
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4 (3.9%) |
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3 (3.0%) |
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7 (6.9%) |
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3 (2.9%) |
Any study drug-related TEAEs leading to discontinuation of study drug |
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2 (2.0%) |
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1 (1.0%) |
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6 (5.9%) |
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1 (1.0%) |
Any study drug related TESAEs |
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0 (0.0%) |
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0 (0.0%) |
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0 (0.0%) |
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0 (0.0%) |
The study was conducted at sites across the United States, and a total of 407 patients with HeFH and/or ASCVD or ASCVD risk equivalents, who had a baseline LDL-C of at least 70 mg/dL, were randomized 1:1:1:1 to receive 10 mg obicetrapib and 10 mg ezetimibe fixed-dose combination, 10 mg obicetrapib, 10 mg ezetimibe or placebo for an 84-day treatment period. The mean baseline LDL-C for enrolled patients in the obicetrapib-ezetimibe arm was 97 mg/dL despite high intensity statin use reported by approximately 74% of patients during screening.
Forward-Looking Statements
Certain statements included in this Current Report on Form 8-K that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the Company’s business and strategic plans, the Company’s commercial opportunity, the therapeutic and curative potential of the Company’s product candidate, the Company’s clinical trials and the timing for enrolling patients, the timing and forums for announcing data, the achievement and timing of regulatory approvals, and plans for commercialization. These statements are based on various assumptions, whether or not identified in this Current Report on Form 8-K, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to the approval of the Company’s product candidate and the timing of expected regulatory and business milestones, including potential commercialization; ability to negotiate definitive contractual arrangements with potential customers; the impact of competitive product candidates; ability to obtain sufficient supply of materials; global economic and political conditions, including the Russia-Ukraine and Israel-Hamas conflict; the effects of competition on the Company’s future business; and those factors described in the Company’s public filings with the Securities and Exchange Commission. Additional risks related to the Company’s business include, but are not limited to: uncertainty regarding outcomes of the Company’s ongoing clinical trials, particularly as they relate to regulatory review and potential approval for its product candidate; risks associated with the Company’s efforts to commercialize a product candidate; the Company’s ability to negotiate and enter into definitive agreements on favorable terms, if at all; the impact of competing product candidates on the Company’s business; intellectual property related claims; the Company’s ability to attract and retain qualified personnel; ability to continue to source the raw materials for its product candidate. If any of these risks materialize or the Company’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect the Company’s expectations, plans, or forecasts of future events and views as of the date of this Current Report on Form 8-K and are qualified in their entirety by reference to the cautionary statements herein. The Company anticipates that subsequent events and developments may cause the Company’s assessments to change. These forward-looking statements should not be relied upon as representing the Company’s assessment as of any date subsequent to the date of this communication. Accordingly, undue reliance should not be placed upon the forward-looking statements. Neither the Company nor any of its affiliates undertakes any obligation to update these forward-looking statements, except as may be required by law.
Item 9.01 |
Financial Statements and Exhibits. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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NewAmsterdam Pharma Company N.V. |
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By: |
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/s/ Michael Davidson |
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Michael Davidson |
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Chief Executive Officer |
Dated: November 20, 2024
Exhibit 99.1
NewAmsterdam Pharma Announces Positive Topline Data from Pivotal Phase 3 TANDEM Clinical Trial Evaluating the Fixed-Dose Combination of
Obicetrapib 10 mg and Ezetimibe 10 mg in Patients with ASCVD or ASCVD Risk Factors and/or HeFH
Achieved
all co-primary endpoints of LS mean reduction in LDL-C on top of maximally tolerated lipid-modifying therapies versus each of placebo,
ezetimibe 10 mg, and obicetrapib 10 mg monotherapy at day 84 with statistical significance (p<0.001)
Obicetrapib
and ezetimibe fixed-dose combination observed to lower LDL-C by approximately 50% at day 84, compared to placebo, with over 70% of patients achieving LDL-C levels below
55 mg/dL
Data supports global regulatory filings of the obicetrapib 10 mg and ezetimibe 10 mg fixed-dose combination
Observed to be well tolerated with safety results in line with prior studies
NewAmsterdam to host conference call today at 8:00 a.m. ET
Naarden, the Netherlands and Miami, USA; November 20, 2024 NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or
NewAmsterdam or the Company), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (CVD)
with elevated low-density lipoprotein cholesterol (LDL-C), for whom existing therapies are not sufficiently effective or well tolerated, today announced
positive topline data from the Companys Phase 3 TANDEM clinical trial (NCT06005597). TANDEM will support global regulatory filings for the 10 mg obicetrapib and 10 mg ezetimibe fixed-dose combination in adult patients with heterozygous
familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors, whose LDL-C is not adequately controlled, despite being on
maximally tolerated lipid-lowering therapy.
The co-primary endpoints were percent change from baseline in LDL-C of the fixed-dose combination compared to each monotherapy arm after 84 days and obicetrapib 10 mg compared to placebo after day 84. Secondary endpoints incorporated percent changes from baseline in other
biomarkers, including lipoprotein(a), non-high-density lipoprotein cholesterol and apolipoprotein B.
The TANDEM
trial met all co-primary endpoints, including the obicetrapib-ezetimibe fixed dose combination achieving an LS mean reduction of 48.6% (p < 0.0001) compared to
placebo at day 84. The observed reductions in all co-primary endpoints are summarized below.
LDL-C percentage change:
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Ezetimibe (n=101) |
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Obicetrapib (n=102) |
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Obicetrapib and Ezetimibe FDC (n=102) |
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Day 84 from placebo |
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Mean % |
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-23.3 |
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-35.5 |
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-52.2 |
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Median % |
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-22.6 |
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-37.2 |
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-54.0 |
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LS mean % |
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-20.7 |
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-31.9 |
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-48.6 |
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Comparison to pbo |
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(p<0.0001) |
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(p<0.0001) |
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Comparison to eze 10 mg |
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(p<0.0001) |
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Comparison to obi 10 mg |
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(p=0.0007) |
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Millions of people across the world are impacted by cardiovascular disease and, despite lifestyle modifications and
current treatment options, a substantial portion of those living with ASCVD and/or HeFH fail to meet their individual LDL-C goals, said John Kastelein, M.D., Ph.D., FESC, Chief Scientific Officer of
NewAmsterdam. We observed clinically meaningful and statistically significant LDL-C lowering, with safety results consistent with our previous clinical studies, in a once daily oral tablet of the
fixed-dose combination of obicetrapib and ezetimibe. We believe these data highlight a potential new treatment that, if approved, could expand options for physicians and contribute to improved patient care for those impacted by CVD.
In the trial, the fixed-dose combination of obicetrapib and ezetimibe was observed to be well tolerated,
with safety results comparable to placebo. The below table summarizes study drug-related treatment emergent adverse events (TEAEs) and study drug-related treatment emergent serious adverse events (TESAEs).
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Placebo (n=102) |
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Ezetimibe (n=101) |
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Obicetrapib (n=102) |
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Obicetrapib / Ezetimibe FDC (n=102) |
Any study drug-related TEAEs |
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4 (3.9%) |
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3 (3.0%) |
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7 (6.9%) |
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3 (2.9%) |
Any study drug-related TEAEs leading to discontinuation of study drug |
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2 (2.0%) |
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1 (1.0%) |
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6 (5.9%) |
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1 (1.0%) |
Any study drug related TESAEs |
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0 (0.0%) |
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0 (0.0%) |
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0 (0.0%) |
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0 (0.0%) |
Todays announcement represents a major achievement in our mission to bring a new and effective therapy to millions
of patients struggling with dyslipidemia, said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam Pharma. We expect these promising results will support our regulatory filings globally and they reinforce our belief that, if
approved, obicetrapib in combination with ezetimibe will potentially offer a simple, once-daily treatment capable of significantly reducing LDL-C and improving cardiovascular outcomes. After the BROOKLYN
trials successful readout in July and the additional safety and efficacy data released this week, we strongly believe that obicetrapib as a monotherapy or in a fixed-dose combination with ezetimibe has the potential to help patients achieve LDL-C targets.
Despite the availability of established therapies, a considerable number of patients still
fail to achieve target LDL-C levels, leaving them vulnerable to future cardiovascular events. These top-line results advance our understanding of potential new tools for
lipid management for patients at high risk of cardiovascular disease, said Ashish Sarraju, M.D., Cardiovascular Medicine, Cleveland Clinic.
NewAmsterdam plans to present additional results from TANDEM at an upcoming medical conference and to publish the data in a major medical journal.
Design of the Pivotal Phase 3 TANDEM Clinical Trial
The
pivotal, Phase 3, randomized, double-blind, four-arm, placebo-controlled multicenter study evaluated the effect of 10 mg obicetrapib and 10 mg ezetimibe as a fixed-dose combination on LDL-C levels, compared to both ezetimibe 10 mg and obicetrapib 10 mg monotherapy and to placebo. The study was conducted at sites across the United States, and a total of 407 patients with HeFH and/or ASCVD or ASCVD
risk equivalents, who had a baseline LDL-C of at least 70 mg/dL, were randomized 1:1:1:1 to receive 10 mg obicetrapib and 10 mg ezetimibe fixed-dose combination, 10 mg obicetrapib, 10 mg ezetimibe or placebo
for an 84-day treatment period. The mean baseline LDL-C for enrolled patients in the obicetrapib-ezetimibe arm was 97 mg/dL
despite high intensity statin use reported by approximately 74% of patients during screening. In addition to measuring the co-primary endpoints and secondary endpoints, the trial also evaluated the safety and
tolerability profile of obicetrapib.
Conference Call and Webcast Information
NewAmsterdam will host a live webcast and conference call to review the topline results from TANDEM at 8:00 a.m. ET today. To access the live webcast,
participants may register here. The live webcast will be available under the Events section of the Investor Relations page of the NewAmsterdam website at ir.newamsterdampharma.com.
To participate via telephone, please register in advance here. Upon registration, all telephone participants will receive a confirmation email detailing how
to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. While not required, it is recommended that participants join the
call ten minutes prior to the scheduled start. An archived replay of the webcast will be available on NewAmsterdams website.
About NewAmsterdams Global Pivotal Phase 3 Program
NewAmsterdams global, pivotal Phase 3 clinical development program consists of four studies in over 12,250 patients, three for obicetrapib monotherapy
and one for a fixed-dose combination of obicetrapib and ezetimibe, including TANDEM. Details on the Companys pivotal Phase 3 programs are as follows:
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BROOKLYN evaluated obicetrapib in patients with HeFH, whose LDL-C is not
adequately controlled, despite being on maximally tolerated lipid-lowering therapy. NewAmsterdam reported topline data in the third quarter of 2024 and presented additional data at the American Heart Association Scientific Sessions 2024 in November.
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TANDEM evaluated obicetrapib as part of a fixed-dose combination tablet with ezetimibe, a non-statin oral LDL-lowering therapy, in patients with established ASCVD or multiple risk factors for ASCVD and/or HeFH, whose LDL-C is
not adequately controlled despite being on maximally tolerated lipid-lowering therapy. NewAmsterdam completed enrollment of over 400 patients in July 2024 and reported topline data in November 2024. |
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BROADWAY is evaluating obicetrapib in adult patients with established ASCVD and/or HeFH, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. NewAmsterdam completed enrollment of over 2,500 patients in July 2023 and expects to report topline data in the fourth
quarter of 2024. |
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PREVAIL is a cardiovascular outcomes trial evaluating obicetrapib in patients with a history of ASCVD, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. NewAmsterdam completed enrollment of over 9,500 patients in April 2024. |
About Obicetrapib
Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In each of the Companys Phase 2 trials, ROSE2,
TULIP, ROSE, and OCEAN, as well as the Companys Phase 3 BROOKLYN and TANDEM trials, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant
LDL-lowering combined with a side effect profile similar to that of placebo. The Company is conducting an additional Phase 3 pivotal trial BROADWAY, to evaluate obicetrapib as a monotherapy used as an adjunct
to maximally tolerated lipid-lowering therapies to provide additional LDL-lowering for CVD patients. The Company began enrolling patients in BROADWAY in January 2022 and completed enrollment of BROADWAY in
July 2023. The Company also commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of major adverse cardiovascular events, including cardiovascular
death, non-fatal myocardial infarction, non-fatal stroke and non-elective coronary revascularization. NewAmsterdam completed
enrollment of PREVAIL in April 2024 and randomized over 9,500 patients. Commercialization rights of obicetrapib in Europe, either as a monotherapy or as part of a fixed dose combination with ezetimibe, for cardiovascular diseases have been
exclusively granted to the Menarini Group, an Italy-based, leading international pharmaceutical and diagnostics company.
About NewAmsterdam
NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases
where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple phase 3
studies, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C
lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated.
Forward-Looking Statements
Certain statements included in this document that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the
United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as believe, may, will, estimate, continue,
anticipate, intend, expect, should, would, plan, predict, potential, seem, seek, future, outlook and
similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the Companys business and
strategic plans, the Companys commercial opportunity, the therapeutic and curative potential of the Companys product candidate, the Companys clinical trials and the timing for enrolling patients, the timing and forums for
announcing data, the achievement and timing of regulatory approvals, and plans for commercialization. These statements are based on various assumptions, whether or not identified in this document, and on the current expectations of the
Companys management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a
prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These
forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to the approval of the Companys product
candidate and the timing of expected regulatory and business milestones, including potential commercialization; ability to negotiate definitive contractual arrangements with potential customers; the impact of competitive product candidates; ability
to obtain sufficient supply of materials; global economic and political conditions, including the Russia-Ukraine and Israel-Hamas conflict; the effects of competition on the Companys future business; and those factors described in the
Companys public filings with the Securities Exchange Commission. Additional risks related to the Companys business include, but are not limited to: uncertainty regarding outcomes of the Companys ongoing clinical trials,
particularly as they relate to regulatory review and potential approval for its product candidate; risks associated with the Companys efforts to commercialize a product candidate; the Companys ability to negotiate and enter into
definitive agreements on favorable terms, if at all; the impact of competing product candidates on the Companys business; intellectual property related claims; the Companys ability to attract and retain qualified personnel; ability to
continue to source the raw materials for its product candidate. If any of these risks materialize or the Companys assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements.
There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition,
forward-looking statements reflect the Companys expectations, plans, or forecasts of future events and views as of the date of this document and are qualified in their entirety by reference to the cautionary statements herein. The Company
anticipates that subsequent events and developments may cause the Companys assessments to change. These forward-looking statements should not be relied upon as representing the Companys assessment as of any date subsequent to the date of
this communication. Accordingly, undue reliance should not be placed upon the forward-looking statements. Neither the Company nor any of its affiliates undertakes any obligation to update these forward-looking statements, except as may be required
by law.
Company Contact
Matthew Philippe
P: 1-917-882-7512
matthew.philippe@newamsterdampharma.com
Media Contact
Spectrum Science on behalf of NewAmsterdam
Bryan
Blatstein
P: 1-917-714-2609
bblatstein@spectrumscience.com
Investor Contact
Precision AQ on behalf of NewAmsterdam
Austin Murtagh
P: 1-212-698-8696
austin.murtagh@precisionaq.com
Exhibit 99.2 TANDEM Topline Results November 20, 2024
Disclaimer This presentation (together with oral statements made in
connection herewith, this “Presentation”) is for informational purposes only. This Presentation shall not constitute an offer to sell, or the solicitation of an offer to buy, any securities, nor shall there be any sale of securities in
any states or jurisdictions in which such offer, solicitation or sale would be unlawful. Forward Looking Statements Certain statements included in this Presentation that are not historical facts are forward-looking statements for purposes of the
safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,”
“estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,”
“seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited
to, statements by NewAmsterdam Pharma Company N.V. (“NewAmsterdam” or the “Company”) regarding estimates and forecasts of other financial and performance metrics and projections of market opportunity; the Company's business
and strategic plans; expectations and timing related to the success, cost and timing of product development activities, including timing of initiation, completion and data readouts for clinical trials and the potential approval of the
Company’s product candidate; the timing for enrolling patients; the timing and forums for announcing data; the size and growth potential of the markets for the Company’s product candidate; the therapeutic and curative potential of the
Company’s product candidate; financing and other business milestones; the Company’s expected cash runway; and the Company’s plans for commercialization. These statements are based on various assumptions, whether or not identified
in this Presentation, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and
must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and
circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks
related to the approval of NewAmsterdam’s product candidate and the timing of expected regulatory and business milestones; whether topline, initial or preliminary results from a particular clinical trial will be predictive of the final results
of that trial and whether results of early clinical trials will be indicative of the results of later clinical trials; ability to negotiate definitive contractual arrangements with potential customers; the impact of competitive product candidates;
ability to obtain sufficient supply of materials; global economic and political conditions, including the Russia-Ukraine conflict, and the war in Israel; the effects of competition on NewAmsterdam’s future business; and those factors discussed
in documents filed by the Company with the SEC. Additional risks related to NewAmsterdam’s business include, but are not limited to: uncertainty regarding outcomes of the company’s ongoing clinical trials, particularly as they relate to
regulatory review and potential approval for its product candidate; risks associated with the Company’s efforts to commercialize a product candidate; the Company’s ability to negotiate and enter into definitive agreements on favorable
terms, if at all; the impact of competing product candidates on the Company’s business; intellectual property-related claims; the Company’s ability to attract and retain qualified personnel; and the Company’s ability to continue to
source the raw materials for its product candidate, together with the risks described in the Company’s filings made with the U.S. Securities and Exchange Commission from time to time. If any of these risks materialize or NewAmsterdam’s
assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that are presently unknown by the Company or that NewAmsterdam currently believes are
immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect NewAmsterdam’s expectations, plans, or forecasts of future events and views as of
the date of this Presentation and are qualified in their entirety by reference to the cautionary statements herein. NewAmsterdam anticipates that subsequent events and developments will cause the Company’s assessments to change. These
forward-looking statements should not be relied upon as representing NewAmsterdam’s assessments as of any date subsequent to the date of this Presentation. Accordingly, undue reliance should not be placed upon the forward-looking statements.
Neither NewAmsterdam nor any of its affiliates undertakes any obligation to update these forward-looking statements, except as required by law. Market Data Certain information contained in this Presentation relates to or is based on third-party
studies, publications, surveys and NewAmsterdam’s own internal estimates and research. In addition, all of the market data included in this Presentation involves a number of assumptions and limitations, and there can be no guarantee as to the
accuracy or reliability of such assumptions. Finally, while NewAmsterdam believes its internal research is reliable, such research has not been verified by any independent source and NewAmsterdam cannot guarantee and makes no representation or
warranty, express or implied, as to its accuracy and completeness. Trademarks This Presentation contains trademarks, service marks, trade names, and copyrights of NewAmsterdam and other companies, which are the property of their respective owners.
The use or display of third parties’ trademarks, service marks, trade name or products in this Presentation is not intended to, and does not imply, a relationship with NewAmsterdam or an endorsement or sponsorship by or of NewAmsterdam. Solely
for convenience, the trademarks, service marks and trade names referred to in this Presentation may appear with the TM or SM symbols, but such references are not intended to indicate, in any way, that NewAmsterdam will not assert, to the 2 fullest
extent permitted under applicable law, their rights or the right of the applicable licensor to these trademarks, service marks and trade names.
Results overview • TANDEM successfully met all co-primary
endpoints with statistical significance: − FDC vs. placebo − FDC vs. ezetimibe − FDC vs. obicetrapib monotherapy, and − Obicetrapib vs. placebo • Continued support for potential synergistic benefit of the combination,
highlighting potential benefit beyond convenience • Safety results consistent with our prior studies • Growth of ezetimibe and non-statin therapies believed to support significant opportunity for the FDC, if approved • Data
supports global regulatory filings of the fixed-dose combination Note: FDC = fixed-dose combination 3
Majority of ASCVD/HeFH Patients have not Demonstrated Achievement of
LDL-C Targets Primary prevention HeFH ASCVD patients with an Very high risk ASCVD Despite availability of patients with LDL-C target of LDL<70 or patients with an LDL-C treatments continue to see 2 an LDL-C target <100 mg/dL <55 mg/dL
(2017-2018) target <55 mg/dL (2020- minimal uptake, especially 1 3 4 (2011-2017) 2021) adjunct to statins LDL-C < 100 mg/dL LDL-C < 70 mg/dL LDL-C < 55 mg/dL Statin Utilization 65.8M 29.6M 29% 24% 10% PCSK9i Utilization 9.7M <1/3
achieved <1/4 achieved 10% achieved LDL-C <100 mg/dL LDL-C <70 mg/dL LDL-C <55 mg/dL 0.253M ASCVD=atherosclerotic cardiovascular disease; HeFH=heterozygous familial hypercholesterolemia; LDL-C=low-density lipoprotein-cholesterol. 1.
Schreuder MM, et al. LDL cholesterol targets rarely achieved in familial hypercholesterolemia patients: A sex and gender-specific analysis. Atherosclerosis. 2023 2. Gao Y, Shah LM, Ding J, Martin SS. US trends in cholesterol screening, lipid levels,
and lipid- lowering medication use in US adults, 1999 to 2018. J Am Heart Assoc. 2023;12(3):e028205; 3. Katzmann JL, et al. Simulation study on LDL cholesterol target attainment, treatment costs, and ASCVD events with bempedoic acid in patients at
high and very-high cardiovascular risk. PLoS One. 2022;17(10):e0276898; 4. J Am Heart Assoc 2022;11:3026075; doi: 10.1161/JAHA.122.026075 4
(10 of each) Study Design and Baseline Characteristics A
Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib 10 mg and Ezetimibe 10 mg Fixed Dose Combination Daily on Top of Maximally Tolerated Lipid-Modifying Therapy in Participants With Heterozygous Familial
Hypercholesterolemia (HeFH) and/or Atherosclerotic Cardiovascular Disease (ASCVD) or Multiple ASCVD Risk Factors Study Design Baseline Lipids (total study population) 1º endpoint N = 407 150 160 140 Obicetrapib 10 mg / Ezetimibe 10mg (n=102)
123 120 97 Obicetrapib 10 mg (n=102) 89 100 80 Ezetimibe 10 mg (n=101) 48 60 40 Placebo (n=102) 20 12-weeks 0 Key Inclusion Criteria LDL-C Non-HDL-C HDL-C ApoB TG • ASCVD Demographics • ASCVD risk equivalents • Female 44% •
LDL-C≥ 70 mg/dL • White 83% • Maximally tolerated lipid lowering therapy 3 • BMI 32 kg/m Key Exclusion Criteria Baseline Lipid Modifying Therapy • Uncontrolled severe hypertension • High intensity statin: 71%
• Diagnosis of homozygous FH Endpoints • Percent change from baseline in LDL-C compared to placebo • Co-Primary Endpoints • FDC vs. Placebo • FDC vs. Eze • FDC vs. Obi • Obi vs. Placebo 5 mg/dL
Additional baseline details of all randomized patients Placebo (n=102)
Ezetimibe (n=101) Obicetrapib (n=102) Obicetrapib and Ezetimibe (n=102) 66.1 67.6 66.7 67.3 Mean Age (years) Sex (F) n (%) 51 (50.0%) 45 (44.6%) 33 (32.4%) 48 (47.1%) Race n (%) White 84 (82.4%) 82 (81.2%) 85 (83.3%) 86 (84.3%) African American 17
(16.7%) 13 (12.9%) 15 (14.7%) 14 (13.7%) Height, cm (mean) 169.9 171.2 169.8 168.8 Weight, kg (mean) 91.7 92.0 92.0 93.6 BMI (mean) 31.7 31.1 31.7 32.8 High intensity statin 75 (73.5%) 71 (70.3%) 66 (64.7%) 75 (73.5%) 6
Obicetrapib/ezetimibe FDC observed to lower LDL-C approx. 50% Ezetimibe
Obicetrapib Obicetrapib and (n=101) (n=102) Ezetimibe (n=102) Day 84 – from placebo Mean % -23.3 -35.5 -52.2 Median % -22.6 -37.2 -54.0 LS mean % -20.7 -31.9 -48.6 Comparison to pbo - (p<0.0001) (p<0.0001) Comparison to eze 10 mg - -
(p<0.0001) Comparison to obi 10 mg - - (p=0.0007) 7
Over 60% of individuals on the FDC saw a more than 50% decrease in LDL-C
Obicetrapib 10mg and ezetimibe 10mg fixed-dose combination 61% >50% LDL-C reduction Note: each line represents a single patient in the fixed-dose combination arm 8
Over 70% of patients on the FDC achieved less than <55 mg/dL
Responder Analysis 9
Continued support for potential synergistic effects in combination
18.5% projected greater reduction in LDL-C in the combination than in the ezetimibe monotherapy arm 68 100 31.9% mg/dL mg/dL Mean baseline in Observed LDL-C Post treatment baseline • Ezetimibe monotherapy showed a 20.7% placebo lowering
obicetrapib obi mono arm arm 24.5% adjusted reduction in LDL-C drop Observed difference • However, the observed LDL-C reduction between between obi mono and FDC 51 the obicetrapib monotherapy arm and the FDC 100 48.6% mg/dL mg/dL arm was
24.5%, which we believe was driven by Mean baseline in Observed LDL-C Calculated FDC the effect of adding ezetimibe to the FDC obi mono arm lowering FDC arm reduction 18.5% • We therefore project 18.5% greater LDL-C increase reduction by
ezetimibe when combined with Observed LDL-C 20.7% obicetrapib in the FDC (24.5% vs 20.7%) than what lowering in eze 10 drop mg arm would be expected with ezetimibe monotherapy alone Note: based on LS mean percent reductions. The calculations above
are hypothetical calculations based on the LDL-C reduction observed in the relevant treatment groups in our TANDEM trial. 10
Observed On-treatment LDL-C reduction for ROSE, ROSE2, BROOKLYN &
TANDEM On-Treatment Analysis of obicetrapib 10 mg Note: ROSE at week 8, ROSE2, BROOKLYN, and TANDEM as of week 12. 11
Observed Lp(a) reduction in TANDEM Lp(a) 12
Safety results consistent with our prior studies Placebo (n=102)
Ezetimibe Obicetrapib Obicetrapib / (n=101) (n=102) Ezetimibe (n=102) Any study drug-related TEAEs 4 (3.9%) 3 (3.0%) 7 (6.9%) 3 (2.9%) Any study drug-related TEAEs leading to 2 (2.0%) 1 (1.0%) 6 (5.9%) 1 (1.0%) discontinuation of study drug Any
study drug related TESAEs 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Note: treatment emergent adverse events (“TEAEs”) and study drug-related treatment emergent serious adverse events (“TESAEs”) 13
Lipid Lowering Therapy (LLT) Market is a Growing Opportunity 1 2 3 4 5
2 3 4 Patients on Lipid lowering Therapy Patients on Non-statin Treatment Patients on Branded Treatment Branded sales driving market 11.0% 1.3% 0.1% opportunity ($ millions) 56MM 4.0MM 700K 19.6% 31% 4.3% Growth Growth Growth 600K 5.4% Growth 26.3%
51MM 3.5MM 500K Growth 17.8% Growth 400K 87.6% 46MM 3.0MM 638K 3.8MM Generic - Statin Generic - non Statin 54MM 300K 51MM Branded - PCSK9 Branded - ACL Inhibitor 487K 49MM 3.2MM 200K 386K 41MM 2.5MM 2.7MM 100K 256M Prescriptions written 36MM 2.0MM
0K 1 Nov '20 to Nov '21 to Nov '22 to Nov '20 to Nov '21 to Nov '22 to Nov '20 to Nov '21 to Nov '22 to in past 12 months. Oct '21 Oct '22 Oct '23 Oct '21 Oct '22 Oct '23 Oct '21 Oct '22 Oct '23 PCSK9 sales accelerating post Over 250 MM Market
growing at over Non-statin market growing Branded market Rx’s annually 4% over the last 2 years at high double digits growing even faster launch miscalculations Recent guideline and label changes driving renewed acceleration 5 2022: ACC
updated guidelines to target LDL-C <55 mg/dl in high-risk patients in line with ESC/EAS 2024: FDA highlights need to reduce access restrictions for LLTs. Labels updated from “on top of maximally tolerated statins” to “treatment
of primary 6 hyperlipidemia” for some LLTs 1. Source: IQVIA XPT - Data Period – 12 months of TRx from Dec ‘22 to Nov ’23 Source: IQVIA LAAD data from Nov ‘20 to Oct ’23 2. All Lipid Lowering therapies: Statins,
Ezetimibe and combinations; PCSK9 and BPA 3. Non-Statins : Ezetimibe and 14 combinations; PCSK9 and BPA 4. Branded: PCSK9 and BPA 5. Lloyd-Jones DM, et al. J Am Coll Cardiol. 2022;80(14):1366-1418 6. Leqvio (inclisiran). Prescribing information.
Novartis; 2023.; Nexletol (bempedoic acid). Prescribing information. Esperion Therapeutics Inc; 2023. Note: LTM=last 12 months ending 2Q24
Conclusions • TANDEM successfully hit all co-primary endpoints,
observed to lower LDL-C by approximately 50%, including: − A greater than 60% reduction in more that 50% of patients, − More than 70% of patients achieved LDL-C below 55 mg/dL • 18.5% synergy projected with combination,
highlighting potential benefit above simple convenience • ~20% ezetimibe and overall market growth believed to support significant market opportunities for obicetrapib and FDC, if approved • Data support global filing of the fixed-dose
combination • Other biomarkers consistent with our prior studies • Additional data to be presented at an upcoming medical conference 15
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