IPO Report: MyoKardia (MYOK)

Francis Gaskins  |

Based in South San Francisco, CA, MyoKardia (MYOK) is a clinical stage biopharmaceutical company pioneering a precision medicine approach to discover, develop and commercialize targeted therapies for the treatment of serious and neglected rare cardiovascular diseases.

Another company is scheduled to IPO in the week of Oct. 26. The full IPO calendar is available at IPO Premium.

MYOK scheduled a $75 million IPO with a market capitalization of $408 million at a price range midpoint of $16 for Thursday, October 29, 2015, on Nasdaq.  SEC Documents

Manager, Joint-managers: Credit Suisse and Cowen and Company

Co-managers: Wedbush and PacGrow

MyoKardia (MYOK) IPO Conclusion


Therapies for the treatment of  rare cardiovascular diseases.

Collaboration partner Sanofi & shareholder expects to purchase $25mm, 33%

PE of -21 , indicate moderate cash burn (expected to increase substantially) relative to market cap,

Price to book of 3.5

End of lockup (180 days): Tuesday, Apri 26, 2016

End of 25-day quiet period: November 23, 2015

MyoKardia (MYOK) IPO Valuation


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MyoKardia (MYOK)








MyoKardia (MYOK) Business

MYOK is a clinical stage biopharmaceutical company pioneering a precision medicine approach to discover, develop and commercialize targeted therapies for the treatment of serious and neglected rare cardiovascular diseases.

MYOK's initial focus is on the treatment of heritable cardiomyopathies, a group of rare, genetically-driven forms of heart failure that result from biomechanical defects in cardiac muscle contraction.

MYOK has used its precision medicine platform to generate an initial pipeline of four therapeutic programs for the chronic treatment of the two most common forms of heritable cardiomyopathy—hypertrophic cardiomyopathy, or HCM, and dilated cardiomyopathy, or DCM.

Lead Product Candidate

The lead product candidate, MYK-461, is an orally-administered small molecule designed to reduce excessive cardiac muscle contractility leading to HCM.

In preclinical models of HCM, MYK-461 has been shown to prevent and reverse disease progression.

MYOK is currently evaluating MYK-461 in three Phase 1 clinical trials.

In the first Phase 1 clinical trial of single ascending doses of MYK-461 in 48 healthy adult volunteers, MYK-461 was shown to be well tolerated across multiple dose levels up to 48 mg and has demonstrated clinical proof of mechanism in reducing cardiac contractility, an important biomarker of disease.

MYOK is currently enrolling two additional Phase 1 clinical trials of MYK-461, the first of which is an open-label single ascending dose, or SAD, trial in adult HCM patients, and the second is a double blind, placebo-controlled, multiple ascending dose, or MAD, trial in healthy adult volunteers.

MYOK1 expects to receive final data from both trials in the middle of 2016 and advance MYK-461 into Phase 2 clinical development in the second half of 2016.

MYOK believes that if approved, MYK-461 would be the first targeted therapy to treat an underlying biomechanical defect leading to HCM.

Second Program

The second program is DCM-1, where MYOK is evaluating several novel drug compounds designed to treat heritable DCM by restoring normal contractility in the diseased DCM heart.

MYOK has identified compounds that have been shown to improve cardiac muscle contractility in animal models at doses above the expected therapeutic range without adverse events or impact on cardiac rhythms.

MYOK intends to initiate a Phase 1 clinical trial of a DCM compound in the first half of 2017.

MYOK believes that if approved, a product candidate from the DCM-1 program would be the first targeted therapy to treat an underlying biomechanical defect leading to DCM.

Clinical trial
In MYOK's first Phase 1 clinical trial, demonstrated proof of mechanism was demonstrated, or the ability of MYK-461 to reduce cardiac muscle contraction, an important biomarker of disease. MYOK intends to expand its approach to deliver treatments with disease-modifying potential for patients with other forms of genetically-driven heart failure.

License and Collaboration Agreement with Sanofi

In August 2014, MYOK entered into the Collaboration Agreement with Aventis, Inc., a wholly-owned subsidiary of Sanofi S.A., that covers three main research programs: the first program in HCM (referred to as MYK- 461 or HCM-1), a second program in HCM (referred to as HCM-2) and the first program in DCM (referred to as DCM-1). For purposes of this presentation, we refer to Sanofi as our co-party to the Collaboration Agreement.

Under the Collaboration Agreement, MYOK is responsible for conducting research and development activities through early human efficacy studies, except for specified research activities to be conducted by Sanofi.

Thereafter, MYOK will lead worldwide development and U.S. commercial activities for the MYK-461 and HCM-2 programs, Sanofi will lead global development and commercial activities for DCM-1 and Sanofi will lead commercial activities for the MYK-461 and HCM-2 programs where it has ex-U.S. commercialization rights.

Sanofi also has the option to co-promote the MYK-461 and HCM-2 programs in the United States only in the event of a potential expanded cardiovascular disease indication outside of the genetically targeted indications for MYK-461 and HCM-2. MYOK has co-commercialization rights to DCM-1 in the United States, at our option.

MYOK is entitled to receive tiered royalties beginning in the mid-single digits to the mid-teens on net sales of certain HCM and DCM finished products outside the United States and on net sales of certain DCM finished products in the United States.

Sanofi is eligible to receive tiered royalties beginning in the mid-single digits to the low teens on our net sales of certain HCM finished products in the United States.

Under the Collaboration Agreement, Sanofi also agreed to provide up to $200.0 million in upfront and milestone payments, equity investments and research and development support.

To date, of such amount, MYOK received from Sanofi an initial non-refundable upfront cash payment of $35.0 million and equity investments of $10.0 million in exchange for Series A-1 redeemable convertible preferred stock and $5.0 million in exchange for Series B redeemable convertible preferred stock.

The total payments MYOK was originally eligible to receive also include a $45.0 million continuation payment, a $25.0 million milestone payment, $45.0 million of approved in-kind research and clinical activities and an obligation to purchase an additional $40.0 million of MYOK capital stock if Sanofi provides notice of its intent to continue the collaboration prior to December 31, 2016.

Under the Collaboration Agreement, Sanofi’s obligation to purchase the additional $40.0 million of  capital stock (which was reduced by $5.0 million for its purchase of the Series B redeemable convertible preferred stock) terminates in connection with certain financing events, including consummation of this offering.

MyoKardia (MYOK) Intellectual Property

MYOK's patent estate includes 2 allowed U.S. patent applications, 2 pending Patent Cooperation Treaty, or PCT, applications, and 2 additional U.S. provisional applications, all of which are exclusively owned by MYOK, with claims relating to all current clinical-stage drug candidates.

With respect to lead drug candidates in the HCM program, MYOK exclusively owns one allowed U.S. patent application relating to the chemical composition of MYK-461 and use thereof.

MyoKardia (MYOK) Competition

In the field of heart failure drug development, principal competitors include Amgen Inc., Bayer AG, Bristol-Myers Squibb Company, C.H. Boehringer Sohn AG & Co. KG, Gilead Sciences, Inc., Novartis AG and Takeda Pharmaceutical Company Limited.

Specific to MYOK's initial drug discovery and development focus areas, it is believed that Gilead Sciences, Inc., Heart Metabolics Limited and Novartis AG have ongoing programs in HCM and that Array BioPharma Inc., Kasiak Research Pvt Ltd., Novartis AG, Vericel Corp. and Zensun (Shanghai) Sci. &Tech. Co., Ltd. have ongoing programs in DCM. Additionally, there may be other companies pursuing therapeutic candidates from which we face current or future competition.

MyoKardia (MYOK) 5% Shareholders pre-IPO

Entities affiliated with Third Rock Ventures 52%

Entities affiliated with Fidelity 13%

Aventis Inc. 11%

MyoKardia (MYOK) Dividends

No dividends planned.

MyoKardia (MYOK) IPO Use of Proceeds

MYOD expects to net $67mm from the IPO, allocated as follows:

$35.0 million to fund the clinical development of MYK-461 through the completion of the planned Phase 2 clinical trials;

$25.0 million to advance ongoing preclinical, discovery and research programs and the expansion of the platform, including SHaRe; and

remaining proceeds, if any, to fund new and ongoing research and development activities, working capital and other general corporate purposes.

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to: http://www.equities.com/disclaimer



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