MyoKardia Reports Third Quarter 2020 Financial Results
05 November 2020 - 10:13PM
MyoKardia, Inc. (Nasdaq: MYOK) today reported financial results for
the third quarter ended September 30, 2020.
Recent Clinical Program
Highlights
Mavacamten for Hypertrophic Cardiomyopathy
(HCM)
- EXPLORER-HCM
Data Presented at the
European Society of Cardiology 2020 Virtual
Congress and
Published in The
Lancet: Results from MyoKardia’s Phase 3
clinical study of mavacamten for the potential treatment of
symptomatic, obstructive HCM demonstrated statistically significant
improvements in patient symptoms and cardiac function, as well as
reductions in left ventricular outflow tract (LVOT) obstruction. In
addition to meeting the primary and all secondary endpoints,
mavacamten showed reductions in biomarkers of cardiac wall stress
and myocardial injury and was well tolerated, with a safety profile
similar to placebo. The benefits observed were consistent across
multiple prespecified subgroups.
Danicamtiv (formerly MYK-491) for Dilated
Cardiomyopathy (DCM)
- Initiated
Phase 2 Clinical Trial of
Danicamtiv in Genetic
DCM: Danicamtiv binds directly to and
activates myosin, the heart’s motor protein, to boost the power of
each contraction without impacting the ability of the heart to
relax and fill with oxygenated blood. MyoKardia’s Phase 2 study of
danicamtiv is enrolling patients with DCM with documented genetic
variants of MYH7 or titin. Pathogenic variants in single genes
encoding proteins of the sarcomere have been associated with the
contractile dysfunction underlying approximately 20-30 percent of
dilated cardiomyopathies.
Recent Corporate Highlights
- Entered
into Strategic Partnership
with LianBio to Develop and Commercialize
Mavacamten in China: The partnership will initially pursue
a registration strategy for mavacamten in China for obstructive
HCM, with plans for additional indications to follow, in keeping
with MyoKardia’s development strategy.
- Bristol-Myers Squibb to
Acquire MyoKardia for
$13.1 Billion in
Cash: Bristol-Myers Squibb (BMS) and
MyoKardia announced a definitive merger agreement under which BMS
will acquire MyoKardia for $13.1 billion, or $225.00 per share in
cash. The transaction is expected to close during the fourth
quarter of 2020.
Third Quarter 2020
Financial Results
- Cash
Position: Cash, cash equivalents and investments as
of September 30, 2020 were $895.9 million, compared to
$430.3 million as of December 31, 2019. The quarter end cash
receipts include $40.0 million from LianBio related to the
strategic partnership to develop and commercialize mavacamten in
greater China.
- R&D Expenses:
Research and development expenses were $59.1 million in the third
quarter of 2020, up from $47.4 million for the same period in 2019.
The increase in R&D expenses was primarily driven by the
payment of approximately $10.0 million to Fulcrum Therapeutics, as
well as increases in personnel, facility and information technology
expenses, offset by reductions in clinical expenses due to
completion of our EXPLORER clinical trial.
- G&A Expenses:
General and administrative expenses were $26.3
million for the third quarter of 2020, compared to $17.7
million for same period in 2019. The increase in G&A
expense was primarily driven by increases in personnel and
professional fees.
- Net Loss: Net loss
was $84.7 million ($1.60 loss per share) for the third quarter of
2020, compared to a net loss of $141.8 million ($3.07 loss per
share) for the third quarter of 2019.
About
MyoKardiaMyoKardia is a clinical-stage
biopharmaceutical company discovering and developing targeted
therapies for the treatment of serious cardiovascular diseases. The
company is pioneering a precision medicine approach to its
discovery and development efforts by 1) understanding the
biomechanical underpinnings of disease; 2) targeting the proteins
that modulate a given condition; 3) identifying patient populations
with shared disease characteristics; and 4) applying learnings from
research and clinical studies to inform and guide pipeline growth
and product advancement. MyoKardia’s initial focus is on small
molecule therapeutics aimed at the proteins of the heart that
modulate cardiac muscle contraction to address diseases driven by
excessive contraction, impaired relaxation, or insufficient
contraction. Among its discoveries are three clinical-stage
therapeutics: mavacamten (formerly MYK-461); danicamtiv (formerly
MYK-491) and MYK-224.
MyoKardia’s mission is to change the world for
people with serious cardiovascular disease through bold and
innovative science.
Forward-Looking StatementsThis
press release contains “forward-looking statements” relating to the
development and commercialization of MyoKardia’s product
candidates, MyoKardia’s collaboration agreement with LianBio, and
the pending acquisition of MyoKardia by Bristol Myers Squibb. Such
forward-looking statements are generally identified by terminology
such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,”
“could,” “intends,” “target,” “projects,” “contemplates,”
“believes,” “estimates,” “predicts,” “potential” or “continue” or
the negative of these terms or other similar words. These
statements are only predictions, and such forward-looking
statements are based on current expectations and involve inherent
risks and uncertainties, including factors that could delay, divert
or change any of them, and could cause actual outcomes and results
to differ materially from current expectations. No forward-looking
statement can be guaranteed. Among other risks are (i) the
development and commercialization of MyoKardia’s product candidates
may be delayed or halted for a variety of reasons,
(ii) MyoKardia may not realize the anticipated benefits of its
collaboration with LianBio, (iii) there can be no guarantee that
the acquisition of MyoKardia by Bristol Myers Squibb will be
completed, or if it is completed, that it will close within the
anticipated time period or that the expected benefits of the
acquisition will be realized, (iv) the outcome of any legal
proceedings that may be instituted against the parties and others
related to the merger agreement and (v) unanticipated difficulties
or expenditures relating to the proposed transaction, the response
of business partners and competitors to the announcement of the
proposed transaction and/or potential difficulties in employee
retention as a result of the announcement and pendency of the
proposed transaction. Forward-looking statements in this report
should be evaluated together with the many uncertainties that
affect MyoKardia’s business, particularly those identified in the
risk factors in MyoKardia’s most recent Annual Report on Form 10-K
for the year ended December 31, 2019 and subsequent quarterly
reports filed on Form 10-Q with the SEC, as well as other documents
that may be filed by MyoKardia from time to time with the SEC.
Except to the extent required by applicable law, MyoKardia
undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. The forward-looking statements made in this
communication relate only to events as of the date on which the
statements are made.
Additional Information about the
Proposed Transaction and Where to Find ItThis press
release is neither an offer to purchase nor a solicitation of an
offer to sell shares, nor is it a substitute for the tender offer
materials that Bristol-Myers Squibb and its acquisition subsidiary
filed with the SEC upon commencement of the tender offer.
Bristol-Myers Squibb and its acquisition subsidiary have filed a
tender offer statement on Schedule TO with the SEC, and MyoKardia
has filed a solicitation/recommendation statement on Schedule 14D-9
with respect to the tender offer. THE TENDER OFFER STATEMENT
(INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL
AND OTHER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION
STATEMENT CONTAIN IMPORTANT INFORMATION THAT SHOULD BE READ
CAREFULLY AND CONSIDERED BY MYOKARDIA’S STOCKHOLDERS BEFORE ANY
DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. Both the
tender offer statement and the solicitation/recommendation
statement were mailed to MyoKardia’s stockholders free of
charge. A free copy of the tender offer statement and the
solicitation/recommendation statement is also available to all
stockholders of MyoKardia by accessing www.myokardia.com or by
contacting MyoKardia’s Investor Relations contact at
ir@myokardia.com. In addition, the tender offer statement and
the solicitation/recommendation statement (and all other documents
filed with the SEC) are available at no charge on the SEC’s
website: www.sec.gov.
MYOKARDIA’S STOCKHOLDERS ARE ADVISED TO READ THE
SCHEDULE TO AND THE SCHEDULE 14D-9, AS EACH MAY BE AMENDED OR
SUPPLEMENTED FROM TIME TO TIME, AND ANY OTHER RELEVANT DOCUMENTS
FILED WITH THE SEC BEFORE THEY MAKE ANY DECISION WITH RESPECT TO
THE TENDER OFFER, BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT
THE PROPOSED TRANSACTION AND THE PARTIES THERETO.
Contacts Michelle Corral
Executive Director, Corporate Communications and Investor Relations
MyoKardia, Inc. 650-351-4690 ir@myokardia.com
Hannah Deresiewicz (investors) Stern Investor
Relations, Inc. 212-362-1200 hannah.deresiewicz@sternir.com
Julie Normant
(media)W2O628-213-3754jnormart@w2ogroup.com
MYOKARDIA, INC.
Condensed Consolidated Balance
Sheets(In thousands, except share and per share
amounts)(Unaudited)
|
|
September 30,2020 |
|
|
December 31,2019 |
|
Assets |
|
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
675,541 |
|
|
$ |
101,436 |
|
Short-term investments |
|
|
220,338 |
|
|
|
314,691 |
|
Consideration due from related party |
|
|
35,000 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
|
12,865 |
|
|
|
7,709 |
|
Total current assets |
|
|
943,744 |
|
|
|
423,836 |
|
Property
and equipment, net |
|
|
19,982 |
|
|
|
15,743 |
|
Operating lease right-of-use assets |
|
|
50,433 |
|
|
|
417 |
|
Long-term investments |
|
|
— |
|
|
|
14,153 |
|
Related
party warrant derivative asset |
|
|
18,765 |
|
|
|
— |
|
Restricted cash and other |
|
|
2,737 |
|
|
|
1,945 |
|
Total assets |
|
$ |
1,035,661 |
|
|
$ |
456,094 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
4,554 |
|
|
$ |
6,237 |
|
Accrued liabilities |
|
|
40,043 |
|
|
|
41,292 |
|
Operating lease liabilities - current |
|
|
7,891 |
|
|
|
383 |
|
Total current liabilities |
|
|
52,488 |
|
|
|
47,912 |
|
Operating lease liability |
|
|
43,717 |
|
|
|
— |
|
Related
party liability |
|
|
93,765 |
|
|
|
— |
|
Other
long-term liabilities |
|
|
713 |
|
|
|
1,908 |
|
Total liabilities |
|
|
190,683 |
|
|
|
49,820 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
|
|
Preferred stock, $0.0001 par value; 5,000,000 shares authorized;
none issued and outstanding |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value, 150,000,000 shares
authorized at September 30, 2020 and December 31, 2019;
53,308,689 and 46,379,073 shares issued and outstanding at
September 30, 2020 and December 31, 2019, respectively |
|
|
5 |
|
|
|
5 |
|
Additional paid-in capital |
|
|
1,541,679 |
|
|
|
884,486 |
|
Accumulated other comprehensive income |
|
|
257 |
|
|
|
549 |
|
Accumulated deficit |
|
|
(696,963 |
) |
|
|
(478,766 |
) |
Total stockholders’ equity |
|
|
844,978 |
|
|
|
406,274 |
|
Total liabilities and stockholders’ equity |
|
$ |
1,035,661 |
|
|
$ |
456,094 |
|
|
|
|
|
|
|
|
|
|
MYOKARDIA, INC.
Condensed Consolidated Statements
of Operations and Comprehensive
Loss(In thousands, except share and per share
amounts)(Unaudited)
|
|
Three Months
EndedSeptember 30, |
|
|
Nine Months
EndedSeptember 30, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
59,074 |
|
|
$ |
47,372 |
|
|
$ |
155,286 |
|
|
$ |
101,270 |
|
Selling, general and administrative |
|
|
26,329 |
|
|
|
17,746 |
|
|
|
66,482 |
|
|
|
45,153 |
|
Repurchase of royalty rights |
|
|
— |
|
|
|
80,000 |
|
|
|
— |
|
|
|
80,000 |
|
Total operating expenses |
|
|
85,403 |
|
|
|
145,118 |
|
|
|
221,768 |
|
|
|
226,423 |
|
Loss from operations |
|
|
(85,403 |
) |
|
|
(145,118 |
) |
|
|
(221,768 |
) |
|
|
(226,423 |
) |
Interest and other income, net |
|
|
668 |
|
|
|
3,332 |
|
|
|
3,592 |
|
|
|
8,775 |
|
Loss before income taxes |
|
|
(84,735 |
) |
|
|
(141,786 |
) |
|
|
(218,176 |
) |
|
|
(217,648 |
) |
Income tax expense
(benefit) |
|
|
9 |
|
|
|
16 |
|
|
|
21 |
|
|
|
(202 |
) |
Net loss |
|
|
(84,744 |
) |
|
|
(141,802 |
) |
|
|
(218,197 |
) |
|
|
(217,446 |
) |
Other comprehensive (loss) income |
|
|
(495 |
) |
|
|
(44 |
) |
|
|
(292 |
) |
|
|
520 |
|
Comprehensive loss |
|
$ |
(85,239 |
) |
|
$ |
(141,846 |
) |
|
$ |
(218,489 |
) |
|
$ |
(216,926 |
) |
Net loss per share, basic and
diluted |
|
$ |
(1.60 |
) |
|
$ |
(3.07 |
) |
|
$ |
(4.38 |
) |
|
$ |
(4.91 |
) |
Weighted average number of
shares used to compute net loss per share, basic and diluted |
|
|
53,101,453 |
|
|
|
46,133,068 |
|
|
|
49,860,879 |
|
|
|
44,255,657 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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