FACT-MASTER
15 hours ago
Doesn't look like there is much public info regarding today's Jefferies chat ( just did a st review) and since it was a private chat, it might be appropriate for ESPR mgmt. to release any material information in a press release.
I'm convinced that the convertible notes need to be dealt with before any big pharma will step up. Was just reviewing article 11 and it is evident that the new pharma co, lets say DS for example, would replace Esperion in the convertible notes agreement.
Therefore, imo, the convertible notes is the "big deal" at the moment, that would hold up any buyout of Esperion, especially if DS was interested, not sure if DS is even incorporated in the US - that appears to be another stipulation in the convertible notes agreement. ( ref paragraph a)
Here is Article 11 of the agreement:
ARTICLE 11
Consolidation, Merger, Sale, Conveyance and Lease
Section 11.01. Company May Consolidate, Etc. on Certain Terms. Subject to the provisions of ?Section 11.02, the Company shall not consolidate with, merge with or into, or sell, convey, transfer or lease all or substantially all of its consolidated properties and assets to another Person (other than any such sale, conveyance, transfer or lease to one or more of the direct or indirect Wholly Owned Subsidiaries of the Company), unless:
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(a) the resulting, surviving or transferee Person (the “Successor Company”), if not the Company, shall be a corporation organized and existing under the laws of the United States of America, any State thereof or the District of Columbia, and the Successor Company (if not the Company) shall expressly assume, by supplemental indenture all of the obligations of the Company under the Notes and this Indenture; and
(b) immediately after giving effect to such transaction, no Default or Event of Default shall have occurred and be continuing under this Indenture.
Section 11.02. Successor Corporation to Be Substituted. In case of any such consolidation, merger, sale, conveyance, transfer or lease (other than any such sale, conveyance, transfer or lease to one or more of the direct or indirect Wholly Owned Subsidiaries of the Company) and upon the assumption by the Successor Company, by supplemental indenture, executed and delivered to the Trustee, of all of the obligations of the Company under the Notes and this Indenture, such Successor Company (if not the Company) shall succeed to and, except in the case of a lease of all or substantially all of the Company’s properties and assets, shall be substituted for the Company, with the same effect as if it had been named herein as the party of the first part, and may thereafter exercise every right and power of, the Company under this Indenture. Such Successor Company thereupon may cause to be signed, and may issue either in its own name or in the name of the Company any or all of the Notes issuable hereunder which theretofore shall not have been signed by the Company and delivered to the Trustee; and, upon the order of such Successor Company instead of the Company and subject to all the terms, conditions and limitations in this Indenture prescribed, the Trustee shall authenticate and shall deliver, or cause to be authenticated and delivered, any Notes that previously shall have been signed and delivered by the Officers of the Company to the Trustee for authentication, and any Notes that such Successor Company thereafter shall cause to be signed and delivered to the Trustee for that purpose. All the Notes so issued shall in all respects have the same legal rank and benefit under this Indenture as the Notes theretofore or thereafter issued in accordance with the terms of this Indenture as though all of such Notes had been issued at the date of the execution hereof. In the event of any such consolidation, merger, sale, conveyance or transfer (but not in the case of a lease), upon compliance with this ?Article 11 the Person named as the “Company” in the first paragraph of this Indenture (or any successor that shall thereafter have become such in the manner prescribed in this ?Article 11) may be dissolved, wound up and liquidated at any time thereafter and, except in the case of a lease, such Person shall be released from its liabilities as obligor and maker of the Notes and from its obligations under this Indenture and the Notes.
In case of any such consolidation, merger, sale, conveyance, transfer or lease, such changes in phraseology and form (but not in substance) may be made in the Notes thereafter to be issued as may be appropriate.
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Section 11.03. Opinion of Counsel to Be Given to Trustee. If the Company is not the Successor Company, no such consolidation, merger, sale, conveyance, transfer or lease shall be effective unless the Trustee shall receive an Officer’s Certificate and an Opinion of Counsel as conclusive evidence that any such consolidation, merger, sale, conveyance, transfer or lease and any such assumption and, if a supplemental indenture is required in connection with such transaction, such supplemental indenture, complies with the provisions of this ?Article 11, that all conditions precedent to such consolidation, merger, sale, conveyance, transfer or lease have been complied with, and such Opinion of Counsel shall state that this Indenture, the Notes, and such supplemental indenture, if any, are the legal, valid and binding obligations of the Successor Company, enforceable against it in accordance with their terms subject to customary qualifications and exceptions.
ARTICLE 12
Immunity of Incorporators, Stockholders, Officers and Directors
Section 12.01. Indenture and Notes Solely Corporate Obligations. No recourse for the payment of the principal of or accrued and unpaid interest on or the payment or delivery of consideration due upon conversion of any Note, or the payment or delivery of consideration due upon conversion, nor for any claim based thereon or otherwise in respect thereof, and no recourse under or upon any obligation, covenant or agreement of the Company in this Indenture or in any supplemental indenture or in any Note, nor because of the creation of any indebtedness represented thereby, shall be had against any incorporator, stockholder, employee, agent, Officer or director or Subsidiary, as such, past, present or future, of the Company or of any successor corporation, either directly or through the Company or any successor corporation, whether by virtue of any constitution, statute or rule of law, or by the enforcement of any assessment or penalty or otherwise; it being expressly understood that all such liability is hereby expressly waived and released as a condition of, and as a consideration for, the execution of this Indenture and the issue of the Notes.
FACT-MASTER
1 day ago
Just taking one last look at this tonight, did a speed read the other day and thought there was a connection to the RIPA debt.
The logic to the moves ESPR mgmt is making, is becoming clearer.
Besides all the great news in and of the past 6-8 months, it's possible, imo, the issue of the convertible notes is the final impediment to the share price moving higher and /or a potential purchaser stepping forward. ( DS, imo is most logical)
Article 13 (particularly Section 13.01 (b)) gives good insight into the pieces of the ESPR puzzle and mgmt's strategic approach to mitigating the various indebtness, imo.
( will be busy all day tomorrow, if you can please post details of the Jeffries chat)
ARTICLE 13
Subordination of the Notes
Section 13.01. Agreement of Subordination. (a) The Company covenants and agrees, and each Holder of Notes issued hereunder by its acceptance thereof likewise covenants and agrees, that all Notes shall be issued subject to the provisions of this ?Article 13; and each Person holding any Note, whether upon original issue or upon transfer, assignment or exchange thereof, accepts and agrees to be bound by such provisions.
(b) The payment in cash of the principal of and accrued and unpaid interest, if any, on, the Redemption Price or Fundamental Change Repurchase Price of, or any cash portion of the Conversion Obligation (if the Company has elected Cash Settlement or Combination Settlement) (excluding cash payable in lieu of delivering fractional shares of Common Stock) due upon conversion of, the Notes is subordinated to the prior payment in full, in cash or other payment satisfactory to the holders of the RIPA Debt, of all obligations under the RIPA Debt.
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(c) No provision of this ?Article 13 shall prevent the occurrence of any default or Event of Default hereunder.
Section 13.02. Payments to Holders. (a) The Company shall not make any payment on or distribution to the Trustee or any Holder in respect of the Company’s obligations under the Notes or repurchase, redeem or otherwise acquire the Notes if:
(i) a default in the payment of any RIPA Debt occurs and is continuing beyond any applicable period of grace; or
(ii) any other default (a “Nonpayment Default”) of RIPA Debt occurs and is continuing that permits any holder, or agent or representative for the holders, of RIPA Debt to accelerate its maturity and the Trustee receives a notice of such default (a “Payment Blockage Notice”) from the Company, any such holder, agent or representative or any other Person permitted to give such notice under this Indenture.
If the Trustee receives any Payment Blockage Notice pursuant to clause (ii) above, no subsequent Payment Blockage Notice shall be effective for purposes of this Section 13.02 unless at least 365 days shall have elapsed since the Trustee’s receipt of the immediately prior Payment Blockage Notice. No Nonpayment Default that existed or was continuing on the date of receipt of any Payment Blockage Notice by the Trustee shall be, or be made, the basis for a subsequent Payment Blockage Notice.
(b) The Company may resume payments on or distributions to the Trustee or any Holder in respect of the Company’s obligations under the Notes or repurchase, redeem or otherwise acquire the Notes:
(i) in the case of a default referred to in clause ?(a)(i) above, upon the date on which such default is cured or waived or ceases to exist; and
(ii) in the case of a Nonpayment Default, the earlier of (i) the date on which such Nonpayment Default is cured, waived or ceases to exist, (ii) 179 days after the date on which the Payment Blockage Notice is received by the Trustee unless the maturity of any RIPA Debt has been accelerated, and (iii) the date on which all obligations in respect of the RIPA Debt have been paid in full in cash or other payment satisfactory to the holders of the RIPA Debt.
(c) Upon any dissolution, winding-up, liquidation or reorganization of the Company (whether voluntary or involuntary) or in bankruptcy, insolvency or similar proceedings, the Company shall pay the holders of RIPA Debt in full in cash or other payment satisfactory to the holders of the RIPA Debt all amounts due and owing thereunder before the Company pays the Holders.
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(d) If the Notes are accelerated because of an Event of Default or subject to repurchase by the Company at the option of the Holders following a Fundamental Change, the Company shall pay the holders of the RIPA Debt in full in cash or other payment satisfactory to the holders of the RIPA Debt all amounts due and owing thereunder before the Company pays the Holders.
(e) In the event that either the Trustee or any Holder of the Notes receives any payment of any obligations with respect to the Notes when (i) the payment is prohibited by this ?Article 13 and (ii) the Trustee or the Holder has actual knowledge that the payment is prohibited, the Trustee or the Holder, as the case may be, shall hold the payment in trust for the benefit of the holders of the RIPA Debt. Upon the proper written request of the holders of RIPA Debt or their agent or representative, the Trustee or the Holder, as the case may be, shall deliver the amounts held in trust to the holders of RIPA Debt or their proper agent or representative.
Section 13.03. Subrogation of Notes. (a) Subject to the payment in full, in cash or other payment satisfactory to the holders of the RIPA Debt, of all obligations under the RIPA Debt, the rights of the Holders shall be subrogated to the extent of the payments or distributions made to the holders of such RIPA Debt pursuant to the provisions of this Section 13.03 (equally and ratably with the holders of all indebtedness of the Company which by its express terms is subordinated to the RIPA Debt to substantially the same extent as the Notes are subordinated and is entitled to like rights of subrogation) to the rights of the holders of the RIPA Debt to receive payments or distributions of cash, property or securities of the Company applicable to the RIPA Debt until the principal of and accrued and unpaid interest, if any, on, the Redemption Price or Fundamental Change Repurchase Price of, or any cash portion of the Conversion Obligation (if the Company has elected Cash Settlement or Combination Settlement) (excluding cash payable in lieu of delivering fractional shares of Common Stock) due upon conversion of, the Notes shall be paid in full, in cash or other payment satisfactory to the holders of the Notes; and, for the purposes of such subrogation, no payments or distributions to the holders of the RIPA Debt of any cash, property or securities to which the Holders or the Trustee would be entitled under this Indenture except for the provisions of this ?Article 13, and no payment over, pursuant to the provisions of this ?Article 13, to or for the benefit of the holders of the RIPA Debt by the Holders or the Trustee shall, as between the Company, its creditors other than holders of the RIPA Debt and the Holders, be deemed to be a payment by the Company to or on account of the Notes. It is understood that the provisions of this ?Article 13 are and are intended solely for the purposes of defining the relative rights of the Holders, on the one hand, and the holders of the RIPA Debt, on the other hand.
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(b) Nothing contained in this ?Article 13 or elsewhere in this Indenture or in the Notes is intended to or shall impair, as among the Company, its creditors other than the holders of the RIPA Debt and the Holders, the obligation of the Company, which is absolute and unconditional, to pay to the Holders the principal of the cash portion of the Conversion Obligation, if any, and any interest on the Notes as and when the same shall become due and payable in accordance with their terms, or is intended to or shall affect the relative rights of the Holders and creditors of the Company other than the holders of the RIPA Debt, nor shall anything herein or therein prevent the Trustee or any Holder from exercising all remedies otherwise permitted by applicable law upon default under this Indenture, subject to the rights, if any, under this ?Article 13 of the holders of the RIPA Debt in respect of cash, property or securities of the Company received upon the exercise of any such remedy.
(c) Upon any payment or distribution of assets of the Company referred to in this ?Article 13, the Trustee and the Holders shall be entitled to rely upon any order or decree made by any court of competent jurisdiction in which such bankruptcy, dissolution, winding-up, liquidation or reorganization proceedings are pending, or a certificate of the receiver, trustee in bankruptcy, liquidating trustee, agent or other Person making such payment or distribution, delivered to the Trustee or to the Holders, for the purpose of ascertaining the Persons entitled to participate in such distribution, the holders of the RIPA Debt and other indebtedness of the Company, the amount thereof or payable thereon and all other facts pertinent thereto or to this ?Article 13.
Section 13.04. Authorization to Effect Subordination. Each Holder by the Holder’s acceptance thereof authorizes and directs the Trustee on the Holder’s behalf to take such action as may be necessary or appropriate to effectuate the subordination as provided in this ?Article 13 and appoints the Trustee to act as the Holder’s attorney-in-fact for any and all such purposes.
Section 13.05. Notice to Trustee. The Company shall give prompt written notice to the Trustee and to any Paying Agent of any fact known to the Company that would prohibit the making of any payment of monies to or by the Trustee or any Paying Agent in respect of the Notes pursuant to the provisions of this ?Article 13. Notwithstanding the provisions of this ?Article 13 or any other provision of this Indenture, the Trustee shall not be charged with knowledge of the existence of any facts which would prohibit the making of any payment of monies to or by the Trustee in respect of the Notes pursuant to the provisions of this ?Article 13, unless and until a Responsible Officer of the Trustee shall have received written notice thereof at the Corporate Trust Office from the Company or from a holder or holders of the RIPA Debt or from any trustee, agent or representative thereof; and before the receipt of any such written notice, the Trustee shall be entitled in all respects to assume that no such facts exist
The Trustee shall be entitled to rely on the delivery to it of a written notice by a Person representing himself to be a holder of the RIPA Debt (or a trustee, agent or representative on behalf of such holder) to establish that such notice has been given by a holder of the RIPA Debt or a trustee, agent or representative on behalf of any such holder or holders. In the event that the Trustee determines in good faith that further evidence is required with respect to the right of any Person as a holder of the RIPA Debt to participate in any payment or distribution pursuant to this ?Article 13, the Trustee may request such Person to furnish evidence to the reasonable satisfaction of the Trustee as to the amount of the RIPA Debt held by such Person, the extent to which such Person is entitled to participate in such payment or distribution and any other facts pertinent to the rights of such Person under this ?Article 13, and if such evidence is not furnished the Trustee may defer any payment to such Person pending judicial determination as to the right of such Person to receive such payment.
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Section 13.06. Trustee’s Relation to RIPA Debt. The Trustee in its individual capacity shall be entitled to all the rights set forth in this ?Article 13 in respect of the RIPA Debt at any time held by it, to the same extent as any other holder of the RIPA Debt, and nothing in this Indenture shall deprive the Trustee of any of its rights as such holder. Any claims of the Trustee for compensation or indemnification shall not be subordinate to the RIPA Debt and shall be senior to the claims of Holders in respect of all funds collected or held by the Trustee.
With respect to the holders of the RIPA Debt, the Trustee undertakes to perform or to observe only such of its covenants and obligations as are specifically set forth in this Article 13, and no implied covenants or obligations with respect to the holders of the RIPA Debt shall be read into this Indenture against the Trustee. The Trustee shall not be deemed to owe any fiduciary duty to the holders of the RIPA Debt, and, except with respect to its express obligations under this ?Article 13 the Trustee shall not be liable to any such holders of the RIPA Debt if the Trustee in good faith mistakenly pays over or distributes to Holders or to the Company or to any other Person, cash, property or securities to which any holders of the RIPA Debt are entitled by virtue of this ?Article 13 or otherwise.
Section 13.07. No Impairment of Subordination. No right of any present or future holder of the RIPA Debt to enforce subordination as herein provided shall at any time in any way be prejudiced or impaired by any act or failure to act on the part of the Company or by any act or failure to act, in good faith, by any such holder or by any noncompliance by the Company with the terms, provisions and covenants of this Indenture, regardless of any knowledge thereof that any such holder may have or otherwise be charged with.
Section 13.08. Certain Conversions Not Deemed Payment. Notwithstanding anything to the contrary in this ?Article 13, the issuance and delivery of shares of the Common Stock (and cash in lieu of fractional shares of Common Stock) upon conversion of any Note in accordance with this Indenture and the Notes or otherwise in exchange for any Note shall be deemed not to constitute a payment on or distribution in respect of the obligations of the Company under any Note or any repurchase, redemption or other acquisition of any Note.
Section 13.09. Article Applicable to Paying Agents. If at any time any Paying Agent other than the Trustee shall have been appointed by the Company and be then acting hereunder, the term “Trustee” as used in this Article shall (unless the context otherwise requires) be construed as extending to and including such Paying Agent within its meaning as fully for all intents and purposes as if such Paying Agent were named in this Article in addition to or in place of the Trustee; provided, however, that the first paragraph of ?Section 13.05 shall not apply to the Company or any Affiliate of the Company if it or such Affiliate acts as Paying Agent.
FACT-MASTER
3 weeks ago
ESPR: Esperion Announces Monetization of European Royalties and Concurrent Payoff and Termination of Existing Revenue Interest Facility
https://finance.yahoo.com/news/esperion-announces-monetization-european-royalties-110000339.html
Esperion Therapeutics, Inc.
– OMERS Life Sciences to Purchase Esperion’s European Royalty on Bempedoic Acid Products for $304.7 Million with European Royalties Reverting to Esperion Once OMERS Receives 1.7 Times its Investment –
– Esperion Retains Rights to Receive all Potential Future Milestones of up to $300 Million Based on Commercial Performance from its Exclusive European Licensee, Daiichi Sankyo Europe –
– Agreement Provides Increased Operational and Financial Flexibility and Strategically Leverages an Asset to Unencumber Balance Sheet from Senior Secured Liens –
ANN ARBOR, Mich., June 28, 2024 (GLOBE NEWSWIRE) -- Esperion (Nasdaq: ESPR) announced today that it has entered into a Royalty Purchase Agreement (the Agreement) with OMERS Life Sciences (OMERS), under which Esperion received approximately $304.7 million in cash from OMERS in exchange for 100% interest, subject to a cap, in Esperion’s royalty entitlement on Daiichi Sankyo Europe’s (DSE) net sales of bempedoic acid products in the European territories for which DSE has an exclusive license from Esperion (see previous announcement here).
Under the terms of the Agreement, OMERS will receive this tiered royalty, which ranges from 15-25% of net bempedoic acid product sales in Europe, until it has received an aggregate amount equal to 1.7x investment. Thereafter, all future DSE royalties will revert back to Esperion. Esperion will continue to receive any earned sales-based milestone payments following the first achievement of defined net sales under the DSE agreement, which could cumulatively amount to up to $300 million in potential future payments.
Concurrently, the company announced that funds received from this transaction have been used for the early, discounted payoff and termination of the Oberland Capital revenue interest facility.
“This transformational transaction provides Esperion with increased operational and financial flexibility. It strategically unencumbers our balance sheet from senior secured liens and leverages what we believe is an undervalued asset that has not been fully recognized in the market,” stated Sheldon Koenig, President and CEO, Esperion. “Importantly, this mutually beneficial deal underscores the potential for our bempedoic acid products in Europe and allows us to benefit from the potential upside of the triple combination product our partner, DSE, is currently pursuing.”
“This agreement significantly enhances our balance sheet and better positions us to focus on optimizing our U.S. commercialization efforts as we build Esperion into a leading biopharmaceutical company bringing new medicines to patients that address unmet medical need,” commented Ben Halladay, Chief Financial Officer, Esperion.
“We are pleased to invest in the future European sales of bempedoic acid, a product which we expect to benefit millions of patients throughout Europe,” said Rob Missere, Managing Director & Head of Life Sciences. “This deal furthers our mandate to deliver an attractive source of long-term return for our more than 600,000 members.”
J. Wood Capital Advisors served as the financial advisor to the company on the royalty sale transaction.
About OMERS Life Sciences
OMERS Life Sciences provides royalty financings and other non-dilutive solutions to biopharma companies and academic institutions, supporting their efforts to address unmet medical needs and improve the quality of life of patients around the world.
OMERS is a jointly sponsored, defined benefit pension plan, with 1,000 participating employers ranging from large cities to local agencies, and over 600,000 active, deferred and retired members. Our members include union and non-union employees of municipalities, school boards, local boards, transit systems, electrical utilities, emergency services and children’s aid societies across Ontario. OMERS teams work in Toronto, London, New York, Amsterdam, Luxembourg, Singapore, Sydney and other major cities across North America and Europe – serving members and employers, and originating and managing a diversified portfolio of high-quality investments in bonds, public and private credit, public and private equity, infrastructure and real estate.
About Esperion Therapeutics
At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases. The status quo is not meeting the health needs of millions of people with high cholesterol – that is why our team of passionate industry leaders is breaking through the barriers that prevent patients from reaching their goals. Providers are moving toward reducing LDL-cholesterol levels as low as possible, as soon as possible; we provide the next steps to help get patients there. Because when it comes to high cholesterol, getting to goal is not optional. It is our life’s work. For more information, visit esperion.com and esperionscience.com and follow us on X at twitter.com/EsperionInc.
FACT-MASTER
2 months ago
ESPR: Esperion Receives Five Year Patent Extension for Bempedoic Acid, Contained in NEXLETOL® and NEXLIZET®
https://finance.yahoo.com/news/esperion-receives-five-patent-extension-120000020.html
Esperion Therapeutics, Inc.
ANN ARBOR, Mich., May 14, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) announced today that the U.S. Patent and Trademark Office (USPTO) issued a U.S. Patent Term Extension (PTE) certificate for bempedoic acid, which is contained in NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets. The certificate extends the term of U.S. Patent No. 7,335,799 by five years through December 3, 2030. The PTE certificate was granted under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984.
This PTE will be listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration (FDA).
INDICATION
NEXLIZET and NEXLETOL are indicated:
The bempedoic acid component of NEXLIZET and NEXLETOL is indicated to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with:
established cardiovascular disease (CVD), or
at high risk for a CVD event but without established CVD.
As an adjunct to diet:
NEXLIZET, alone or in combination with other LDL-C lowering therapies, to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.
NEXLETOL, in combination with other LDL-C lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.
IMPORTANT SAFETY INFORMATION
NEXLIZET and NEXLETOL are contraindicated in patients with a prior hypersensitivity to bempedoic acid or ezetimibe or any of the excipients. Serious hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported.
Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels, which may lead to gout. Hyperuricemia may occur early in treatment and persist throughout treatment, returning to baseline following discontinuation of treatment. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.
Tendon Rupture: Bempedoic acid, a component of NEXLIZET and NEXLETOL, is associated with an increased risk of tendon rupture or injury. Tendon rupture may occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders. Discontinue NEXLIZET or NEXLETOL at the first sign of tendon rupture. Consider alternative therapy in patients who have a history of tendon disorders or tendon rupture.
The most common adverse reactions in the primary hyperlipidemia trials of bempedoic acid, a component of NEXLIZET and NEXLETOL, in ≥2% of patients and greater than placebo were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes.
Adverse reactions reported in ≥2% of patients treated with ezetimibe (a component of NEXLIZET) and at an incidence greater than placebo in clinical trials were upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue, and influenza.
In the primary hyperlipidemia trials of NEXLIZET, the most commonly reported adverse reactions (incidence ≥3% and greater than placebo) observed with NEXLIZET, but not observed in clinical trials of bempedoic acid or ezetimibe, were urinary tract infection, nasopharyngitis, and constipation.
The most common adverse reactions in the cardiovascular outcomes trial for bempedoic acid, a component of NEXLIZET and NEXLETOL, at an incidence of ≥2% and 0.5% greater than placebo were hyperuricemia, renal impairment, anemia, elevated liver enzymes, muscle spasms, gout, and cholelithiasis.
Discontinue NEXLIZET or NEXLETOL when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. Because of the potential for serious adverse reactions in a breast-fed infant, breastfeeding is not recommended during treatment with NEXLIZET or NEXLETOL.
Report pregnancies to Esperion Therapeutics, Inc. Adverse Event reporting line at 1-833-377-7633.
Please see full Prescribing Information for NEXLIZET and NEXLETOL.
Esperion Therapeutics
At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases. The status quo is not meeting the health needs of millions of people with high cholesterol – that is why our team of passionate industry leaders is breaking through the barriers that prevent patients from reaching their goals. Providers are moving toward reducing LDL-cholesterol levels as low as possible, as soon as possible; we provide the next steps to help get patients there. Because when it comes to high cholesterol, getting to goal is not optional. It is our life’s work. For more information, visit esperion.com and esperionscience.com and follow us on X at twitter.com/EsperionInc.
FACT-MASTER
2 months ago
https://www.sec.gov/ix?doc=/Archives/edgar/data/1434868/000162828024021717/espr-20240508.htm
Item 8.01. Other Events.
As previously disclosed, in March and April 2024, Esperion Therapeutics, Inc. (“Esperion”) received notice letters from nine pharmaceutical companies, six of which filed exclusively with respect to NEXLETOL® (bempedoic acid) Tablet and three of which filed with respect to NEXLETOL and NEXLIZET® (bempedoic acid and ezetimibe) Tablet (each, an “ANDA Filer”), notifying Esperion that each company had filed an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration (“FDA”) seeking approval of a generic version of NEXLETOL and/or NEXLIZET in the United States, as applicable.
On May 8, 2024, Esperion filed a patent infringement lawsuit under the Hatch-Waxman Act in the United States District Court, District of New Jersey, against Micro Labs USA Inc. (along with an affiliate), an ANDA Filer with respect to NEXLETOL. Esperion’s complaint alleges that by filing the applicable ANDA, such ANDA Filer has infringed NEXLETOL’s Orange Book patents included in its Paragraph IV certifications, and seek an injunction preventing FDA from granting final approval of the ANDA before the expiration of the asserted patents, and a permanent injunction to prevent the ANDA Filer from commercializing a generic version of NEXLETOL until the expiration of the asserted patents. Esperion intends to file similar patent infringement lawsuits under the Hatch-Waxman Act against the other ANDA Filers with respect to NEXLETOL and/or NEXLIZET, as applicable.
The ANDAs each contained Paragraph IV certifications alleging that certain of Esperion’s Orange Book listed patents covering NEXLETOL or NEXLIZET, as applicable, are invalid and/or will not be infringed by each ANDA Filer’s manufacture, use or sale of the medicine for which the ANDA was submitted.
Esperion intends to vigorously defend its intellectual property. The filing of the lawsuit within 45 days of receipt of the notice letter from the applicable ANDA filer triggered a stay of FDA approval of such ANDA for up to 30 months following the expiry of the New Chemical Entity exclusivity in accordance with the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”).
Forward Looking Statements
This Current Report on Form 8-K contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including, without limitation, statements related to anticipated patent infringement litigation. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties, including, among others: fluctuations in the Company’s stock price, changes in market conditions, and the risks detailed in the Company’s filings with the Securities and Exchange Commission (the “Commission”), including in the Company’s most recent Annual Report on Form 10-K and in subsequent filings with the Commission. Any forward-looking statements contained in this Current Report on Form 8-K speak only as of their respective dates, and the Company disclaims any obligation or undertaking to update or revise any forward-looking statements, other than to the extent required by law.
FACT-MASTER
2 months ago
ESPR: Esperion Reports First Quarter 2024 Financial Results
https://finance.yahoo.com/news/esperion-reports-first-quarter-2024-100000893.html
Esperion Therapeutics, Inc.
– Q1 Total Revenue Grew 467% Y/Y to $137.7 Million, Reflecting Strong Growth Globally –
– Q1 U.S. Net Product Revenue Grew 46% Y/Y to $24.8 Million –
– Q1 Retail Prescription Equivalents Grew 43% Y/Y and 6% Q/Q, Increased Momentum from Label Expansions Expected Throughout 2024 –
– Received U.S. FDA Approval of Broad New Label Expansions for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet, Becoming the First LDL-C Lowering Non-Statins to Prevent Heart Attacks and Reduce Cardiovascular Risk in Primary and Secondary Prevention Patients –
– Received Positive Opinion from the Committee for Medical Products for Human Use (CHMP); European Commission Decision for Expanded Labels Anticipated in Q2 2024 –
– Conference Call and Webcast Today at 8:00 a.m. ET –
ANN ARBOR, Mich., May 07, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today reported financial results for the first quarter ended March 31, 2024, and provided a business update.
“We are proud of our strong start to 2024 and the continued momentum and growth we again delivered in the first quarter,” said Sheldon Koenig, President and CEO. “We posted retail prescription equivalent growth of 43% year-over-year, generated our highest level of revenue yet, and ended the quarter with a cash balance that positions us to capitalize on our new label and deliver long term value growth.”
“We also received FDA approval of our highly anticipated label expansions for NEXLETOL and NEXLIZET, which we believe positions us for a meaningful uptick in growth. As the only oral LDL-cholesterol (LDL-C) lowering non-statins approved for reducing cardiovascular risk in both primary and secondary prevention patients, our expanded labels will enable us to potentially reach more than 70 million new patients in need of an alternative therapy. We believe this approval brings us closer to bridging the statin gap, which encompasses an underserved patient population that is unable to reach their LDL-C goal on current therapies alone.”
“We have prioritized investment in our commercial strategy, including ramping up our sales force, launching our new Lipid Lurker consumer campaign, developing a suite of new promotional materials, and initiating partnerships to provide improved interim access with the payer and patient communities. We’re also pleased to report utilization management criteria updates that will be made by two major payers in the next two months that covers 40 million lives, and anticipate additional payers aligning with our new labels on a weekly basis. Looking to our global ex-U.S. franchise., our partner Daiichi Sankyo Europe (DSE) continued to drive increased sales across newly launched territories, signaling the growth potential of these products globally. In summary, with our reinforced commercial infrastructure and recent payer wins, we are poised for significant growth and I look forward to sharing our progress in the coming quarters.”
First Quarter 2024 Key Accomplishments and Recent Highlights
Granted expanded label from the FDA for NEXLETOL and NEXLIZET on March 22, 2024. The label expansion added prevention of heart attacks and reduction of cardiovascular risk as indications and expanded the LDL-C lowering indication to include use with or without a statin. The updates to the label expand accessibility by approximately 70 million patients in the U.S.
Initiated new commercial initiatives to increase patient awareness of NEXLETOL and NEXLIZET’s expanded labels. Expanded our sales force to 150 representatives in the U.S. and developed new promotional materials and tools to supplement salesforce efforts. Initiated partnerships to provide interim patient access while working with payers to update utilization management criteria and streamline transition to the new and expanded labels.
Received positive opinions from the Committee for Medical Products for Human Use (CHMP) of the European Medical Agency (EMA) on March 22, 2024. The opinions were based on the updated label of NILEMDO® (bempedoic acid) and NUSTENDI® (bempedoic acid / ezetimibe fixed dose combination), which were recommended for the reduction of LDL-C and cardiovascular risk. The European Commission is expected to deliver its determination on the pending label update applications in the second quarter of 2024.
Reported royalty revenue of $6.6 million in the first quarter, representing a year-over-year increase of 164%. DSE launched in the Netherlands, Czech Republic, and Slovakia during the first quarter of 2024. Daiichi Sankyo Company, Limited (“DS ASCA”) received approvals in Thailand and Myanmar during the first quarter of 2024.
Presented prespecified subgroup analyses from the CLEAR Outcomes trial at ACC 2024. The subgroup analyses evaluated key underserved and understudied populations, including patients with obesity, women, and Hispanics/Latinx. CLEAR Outcomes enrolled 48% women and 17% Hispanic/Latinx patients, setting a new standard for diversity and inclusion in clinical trials. NEXLETOL demonstrated a 23% reduction in major adverse cardiovascular events (MACE-4) versus placebo in obese patients and had clinical benefits in women and Hispanic/Latinx patients with and without cardiovascular disease.
Initiated the technology transfer process for NILEMDO and NUSTENDI tablet manufacturing to DSE for its territories, which we expect to be completed in the second half of 2025. Additionally, as part of our amended partnership, we authorized DSE to proceed with commercialization of a triple formulation product comprising bempedoic acid, ezetimibe, and a statin, which, if approved, has the potential to meaningfully extend the product’s lifecycle in Europe.
Our collaboration with Otsuka in Japan remains on track, with Otsuka’s phase III study expected to close out in Q2 2024, an anticipated Japan New Drug Application (JNDA) filing in late 2024, and approval and National Health Insurance (NHI) pricing in 2025.
First Quarter 2024 Financial Results
Total revenue was $137.7 million, compared to $24.3 million for the comparable period in 2023, an increase of approximately 467%.
U.S. net product revenue was $24.8 million, compared to $17.0 million for the comparable period in 2023, an increase of approximately 46%, driven by retail prescription growth of 43%.
Collaboration revenue was $113.0 million, compared to $7.3 million for the comparable period in 2023, an increase of 1,448%, driven by increased tablet sales to our international partners and sales growth within partner territories along with the settlement related milestone payment.
Research and development expenses were $13.4 million, compared to $31.4 million for the comparable period in 2023, a decrease of 57%. The decrease is primarily related to the close-out of our CLEAR Outcomes study.
Selling, general and administrative expenses were $42.0 million, compared to $29.9 million for the comparable period in 2023, an increase of 40%. The increase is primarily related to the ramp up of our sales force ahead of our commercial launch in addition to bonus payments and promotional costs.
Total net income for the quarter was $61.0 million, compared to a net loss of $61.7 million for the comparable period in 2023.
Basic net income per share was $0.36, compared to basic and diluted net loss per share of $0.79 for the comparable period in 2023. Diluted net income per share was $0.34.
As of March 31, 2024, cash and cash equivalents totaled $226.6 million, which includes our legal settlement and $90.7 million in net proceeds from our underwritten public offering in January 2024, compared with $82.2 million as of December 31, 2023.
The Company ended the quarter with approximately 187.9 million shares of common stock outstanding, excluding 2.0 million treasury shares to be purchased in the prepaid forward transaction as part of the convertible debt financing.
2024 Financial Outlook
The Company still expects full year 2024 operating expenses to be approximately $225 million to $245 million, including $20 million in non-cash expenses related to stock compensation.
Conference Call and Webcast Information
Esperion will host a webcast at 8:00 a.m. ET to discuss financial results and business progress. Please click here to pre-register to participate in the conference call and obtain your dial in number and PIN.
A live audio webcast can be accessed on the investor and media section of the Esperion website at esperion.com/investor-relations/events. Access to the webcast replay will be available approximately two hours after completion of the call and will be archived on the Company's website for approximately 90 days.
INDICATION
NEXLIZET and NEXLETOL are indicated:
The bempedoic acid component of NEXLIZET and NEXLETOL is indicated to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with:
established cardiovascular disease (CVD), or
at high risk for a CVD event but without established CVD.
As an adjunct to diet:
NEXLIZET, alone or in combination with other LDL-C lowering therapies, to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.
NEXLETOL, in combination with other LDL-C lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.
IMPORTANT SAFETY INFORMATION
NEXLIZET and NEXLETOL are contraindicated in patients with a prior hypersensitivity to bempedoic acid or ezetimibe or any of the excipients. Serious hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported.
Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels, which may lead to gout. Hyperuricemia may occur early in treatment and persist throughout treatment, returning to baseline following discontinuation of treatment. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.
Tendon Rupture: Bempedoic acid, a component of NEXLIZET and NEXLETOL, is associated with an increased risk of tendon rupture or injury. Tendon rupture may occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders. Discontinue NEXLIZET or NEXLETOL at the first sign of tendon rupture. Consider alternative therapy in patients who have a history of tendon disorders or tendon rupture.
The most common adverse reactions in the primary hyperlipidemia trials of bempedoic acid, a component of NEXLIZET and NEXLETOL, in =2% of patients and greater than placebo were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes.
Adverse reactions reported in =2% of patients treated with ezetimibe (a component of NEXLIZET) and at an incidence greater than placebo in clinical trials were upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue, and influenza.
In the primary hyperlipidemia trials of NEXLIZET, the most commonly reported adverse reactions (incidence =3% and greater than placebo) observed with NEXLIZET, but not observed in clinical trials of bempedoic acid or ezetimibe, were urinary tract infection, nasopharyngitis, and constipation.
The most common adverse reactions in the cardiovascular outcomes trial for bempedoic acid, a component of NEXLIZET and NEXLETOL, at an incidence of =2% and 0.5% greater than placebo were hyperuricemia, renal impairment, anemia, elevated liver enzymes, muscle spasms, gout, and cholelithiasis.
Discontinue NEXLIZET or NEXLETOL when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. Because of the potential for serious adverse reactions in a breast-fed infant, breastfeeding is not recommended during treatment with NEXLIZET or NEXLETOL.
Report pregnancies to Esperion Therapeutics, Inc. Adverse Event reporting line at 1-833-377-7633.
Please see full Prescribing Information for NEXLIZET and NEXLETOL.
Esperion Therapeutics
At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases. The status quo is not meeting the health needs of millions of people with high cholesterol – that is why our team of passionate industry leaders is breaking through the barriers that prevent patients from reaching their goals. Providers are moving toward reducing LDL-cholesterol levels as low as possible, as soon as possible; we provide the next steps to help get patients there. Because when it comes to high cholesterol, getting to goal is not optional. It is our life’s work. For more information, visit esperion.com and esperionscience.com and follow us on X at twitter.com/EsperionInc.
CLEAR Cardiovascular Outcomes Trial
CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet. The CLEAR Program seeks to generate important clinical evidence on the safety and efficacy of bempedoic acid, a first in a class ATP citrate lyase inhibitor contained in NEXLETOL and NEXLIZET and its potential role in addressing additional critical unmet medical needs. More than 60,000 people will have participated in the program by the time of its completion. The CLEAR Program includes 5 label-enabling Phase III studies as well as other key Phase IV studies with the potential to reach more than 70 million people with or at risk for CVD based on elevated LDL-C.
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