UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number:
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(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ | |
☒ | Smaller reporting company | |||
Emerging growth company |
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.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
As of November 4th, 2021, the registrant had
Table of Contents
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Notes to Unaudited Condensed Consolidated Financial Statements | 7 | |
Management’s Discussion and Analysis of Financial Condition and Results of Operations | 16 | |
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“Milestone Pharmaceuticals” and the Milestone logo appearing in this Quarterly Report on Form 10-Q are unregistered trademarks of Milestone Pharmaceuticals Inc. All other trademarks, trade names and service marks appearing in this Quarterly Report on Form 10-Q are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Quarterly Report on Form 10-Q may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert their rights thereto.
This Quarterly Report on Form 10-Q contains references to United States dollars and Canadian dollars. All dollar amounts referenced, unless otherwise indicated, are expressed in United States dollars. References to “$” are to United States dollars and references to “C$” are to Canadian dollars.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future financial condition, future operations, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "predict," "positioned," "potential," "seek," "should," "target," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology.
We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of known and unknown risks, uncertainties and assumptions, including risks described in the section titled "Risk Factors" and elsewhere in this Quarterly Report on Form 10-Q, regarding, among other things:
● | the initiation, timing, progress and results of our current and future clinical trials of etripamil, including our Phase 3 clinical trials of etripamil for the treatment of paroxysmal supraventricular tachycardia, our Phase 2 clinical trial of etripamil for the treatment of atrial fibrillation with rapid ventricular rate, and of our research and development programs; |
● | uncertain impacts that the COVID-19 pandemic may have on our business, strategy, clinical trial progress and research and development efforts; |
● | our plans to develop and commercialize etripamil and any future product candidates; |
● | our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; |
● | our ability to develop and, if approved by regulatory authorities, commercialize etripamil in China and Taiwan through our license agreement with Ji Xing Pharmaceuticals; |
● | our ability to establish collaborations or obtain additional funding; |
● | our ability to obtain regulatory approval of our current and future product candidates; |
● | our expectations regarding the potential market size and the rate and degree of market acceptance of etripamil and any future product candidates; |
● | our ability to fund our working capital requirements and expectations regarding the sufficiency of our capital resources; |
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● | the implementation of our business model and strategic plans for our business, etripamil and any future product candidates; |
● | our intellectual property position and the duration of our patent rights; |
● | developments or disputes concerning our intellectual property or other proprietary rights; |
● | our expectations regarding government and third-party payer coverage and reimbursement; |
● | our ability to compete in the markets we serve; |
● | the impact of government laws and regulations; |
● | developments relating to our competitors and our industry; and |
● | other factors that may impact our financial results. |
The foregoing list of risks is not exhaustive. Other sections of this Quarterly Report on Form 10-Q and the section titled "Risk Factors" previously disclosed in Part I, Item 1A. in our Annual Report on Form 10-K may include additional factors that could harm our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements.
In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report on Form 10-Q, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur at all. You should refer to the section titled "Risk Factors" previously disclosed in Part I, Item 1A. in our Annual Report on Form 10-K, filed with the SEC on March 29, 2021, for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
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PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
Milestone Pharmaceuticals Inc.
Condensed Consolidated Balance Sheets (Unaudited)
(in thousands, except share data)
| September 30, 2021 |
| December 31, 2020 | |||
Assets |
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Current assets |
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Cash and cash equivalents | $ | |
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Short-term investment (note 4) | | | ||||
Research and development tax credits receivable | |
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Prepaid expenses | |
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Other receivables | |
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Total current assets | |
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Operating lease assets | | | ||||
Property and equipment | |
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Total assets | $ | |
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Liabilities, and Shareholders' Equity |
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Current liabilities |
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Accounts payable and accrued liabilities (note 5) | $ | |
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Operating lease liabilities | |
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Total current liabilities | |
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Operating lease liabilities (net of current portion) | |
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Total liabilities | |
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Shareholders’ Equity (note 6, note 7) |
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Common shares, | |
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Pre-funded warrants - | | | ||||
Additional paid-in capital | |
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Cumulative translation adjustment | ( |
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Accumulated deficit | ( |
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Total shareholders’ equity | |
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Total liabilities and shareholders’ equity | $ | |
| $ | |
The accompanying notes are an integral part of these interim condensed consolidated financial statements.
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Milestone Pharmaceuticals Inc.
Condensed Consolidated Statements of Loss (Unaudited)
(in thousands, except share and per share data)
Three months ended September 30, | Nine months ended September 30, | |||||||||||
| 2021 |
| 2020 |
| 2021 |
| 2020 | |||||
Revenue (note 3) | $ | — |
| $ | — | $ | |
| $ | — | ||
Operating expenses |
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Research and development, net of tax credits |
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General and administrative |
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Commercial |
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Loss from operations |
| ( |
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Interest income, net |
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Loss before income taxes | ( | ( | ( | ( | ||||||||
Income tax benefit | — |
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Net loss |
| $ | ( |
| $ | ( | $ | ( |
| $ | ( | |
Weighted average number of shares and pre-funded warrants outstanding, basic & diluted | | | | | ||||||||
Net loss per share, basic and diluted (note 8) |
| $ | ( |
| $ | ( | $ | ( |
| $ | ( | |
The accompanying notes are an integral part of these interim condensed consolidated financial statements.
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Milestone Pharmaceuticals Inc.
Condensed Consolidated Statements of Shareholders’ Equity (Unaudited)
(in thousands, except share data)
Common Shares | Pre-funded warrants | |||||||||||||||||||||
| Number |
| Amount |
| Number |
| Amount |
| Additional |
| Cumulative |
| Accumulated |
| Total | |||||||
Balance as of June 30, 2020 | | $ | | — | $ | — | $ | | $ | ( | $ | ( | $ | | ||||||||
Transactions in three-month period ended September 30, 2020 | ||||||||||||||||||||||
Net loss | — | — | — | — | — | — | ( | ( | ||||||||||||||
Exercise of stock options | | | — | — | ( | — | — | | ||||||||||||||
Share-based compensation | — | — | — | — | | — | — | | ||||||||||||||
Pre-funded warrants - Private Placement | — | — | | | — | — | — | | ||||||||||||||
Balance as of September 30, 2020 | | $ | | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||||
Balance as of June 30, 2021 | | $ | | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||||
Transactions in three-month period ended September 30, 2021 | ||||||||||||||||||||||
Net income | — | — | — | — | — | — | ( | ( | ||||||||||||||
Exercise of stock options (note 7) | | | — | — | ( | — | — | | ||||||||||||||
Private Placement (note 7) | — | — | — | — | — | — | — | — | ||||||||||||||
Share-based compensation (note 7) | — | — | — | — | | — | — | | ||||||||||||||
Balance as of September 30, 2021 | | $ | | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||||
Common Shares | Pre-funded warrants | |||||||||||||||||||||
| Number |
| Amount |
| Number |
| Amount |
| Additional |
| Cumulative |
| Accumulated |
| Total | |||||||
Balance as of December 31, 2019 | | $ | | — | $ | — | $ | | $ | ( | $ | ( | $ | | ||||||||
Transactions in nine-month period ended September 30, 2020 | ||||||||||||||||||||||
Net loss | — | — | — | — | — | — | ( | ( | ||||||||||||||
Exercise of stock options | | | — | — | ( | — | — | | ||||||||||||||
Share-based compensation | — | — | — | — | | — | — | | ||||||||||||||
Pre-funded warrants - Private Placement | — | — | | | — | — | — | | ||||||||||||||
Balance as of September 30, 2020 | | $ | | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||||
Balance as of December 31, 2020 | | $ | | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||||
Transactions in nine-month period ended September 30, 2021 | ||||||||||||||||||||||
Net income | — | — | — | — | — | — | ( | ( | ||||||||||||||
Exercise of stock options (note 7) | | | — | — | ( | — | — | | ||||||||||||||
Private Placement (note 7) | — | — | | | — | — | — | | ||||||||||||||
Share-based compensation (note 7) | — | — | — | — | | — | — | | ||||||||||||||
Balance as of September 30, 2021 | | $ | | | $ | | $ | | $ | ( | $ | ( | $ | |
The accompanying notes are an integral part of these interim condensed consolidated financial statements.
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Milestone Pharmaceuticals Inc.
Condensed Consolidated Statements of Cash Flows (Unaudited)
(in thousands)
Nine months ended September 30, | ||||||
2021 |
| 2020 | ||||
Cash flows used in operating activities | ||||||
Net loss | $ | ( | $ | ( | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
Depreciation of property and equipment | | | ||||
Share-based compensation expense (note 7) | | | ||||
Changes in operating assets and liabilities: | ||||||
Other receivables | | | ||||
Research and development tax credits receivable | | ( | ||||
Prepaid expenses | ( | ( | ||||
Operating lease assets and liabilities | | ( | ||||
Accounts payable and accrued liabilities | ( | ( | ||||
Net cash used in operating activities | ( | ( | ||||
Cash provided by (used in) investing activities | ||||||
Acquisition of short-term investments | ( | ( | ||||
Redemption of short-term investments | | | ||||
Net cash provided by (used in) investing activities | | ( | ||||
Cash provided by financing activities | ||||||
Proceeds from exercise of options (note 7) | | | ||||
Proceeds from issuance of pre-funded warrants, net of issuance cost (note 6) | | | ||||
Cash provided by financing activities | | | ||||
Net increase (decrease) in cash and cash equivalents | | ( | ||||
Cash and cash equivalents – Beginning of period | | | ||||
Cash and cash equivalents – End of period | $ | | $ | |
The accompanying notes are an integral part of these interim condensed consolidated financial statements.
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For The Three and Nine Months Ended September 30, 2021 and 2020 (Unaudited)
(in thousands, except where noted and for share and per share data)
1 Organization and nature of operations
Milestone Pharmaceuticals Inc. (Milestone or the Company) is a biopharmaceutical company incorporated under the Business Corporations Act of Québec. Milestone is focused on the development and commercialization of cardiovascular medicines. Milestone’s lead product candidate, etripamil, is a novel, potent short-acting calcium channel blocker that the Company designed and is developing as a rapid-onset nasal spray to be administered by patients. The Company is developing etripamil to treat paroxysmal supraventricular tachycardia, atrial fibrillation, and other cardiovascular indications.
2 Summary of significant accounting policies
a) Basis of consolidation
The consolidated financial statements include the accounts of the Company and Milestone Pharmaceuticals USA, Inc. All intercompany transactions and balances have been eliminated.
b) Basis of presentation and use of accounting estimates and significant accounting policies
These unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (US GAAP) and on a basis consistent with those accounting principles followed by the Company and disclosed in note 2 of its most recent annual consolidated financial statements. Certain information, in particular the accompanying notes normally included in the annual financial statements prepared in accordance with US GAAP have been omitted or condensed. Accordingly, the unaudited interim condensed consolidated financial statements do not include all the information required for full annual financial statements, and therefore, should be read in conjunction with the annual consolidated financial statements and the notes thereto for the year ended December 31, 2020.
In the opinion of the Company's management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments, consisting of only normal recurring adjustments, necessary for a fair statement of its balance sheet as of September 30, 2021, and its statements of loss, shareholders’ equity for the three and nine months ended September 30, 2021 and 2020 and its statement of cash flows for the nine months ended September 30, 2021.
The condensed consolidated balance sheet as of December 31, 2020, was derived from audited annual consolidated financial statements, but does not contain all the footnote disclosures required by accounting principles generally accepted in the United States of America.
These unaudited interim condensed consolidated financial statements are presented in US dollars, which is the Company’s functional currency.
The preparation of unaudited interim condensed consolidated financial statements with US GAAP requires the Company to make estimates and judgments that affect certain reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited interim condensed consolidated financial statements and the reported amounts of revenue and expenses during the period. The Company bases its estimates and assumptions on current facts, historical experience and various other factors that it believes are reasonable under the circumstances, to determine the carrying values of assets and liabilities that are not readily apparent from other sources. Significant estimates and judgments include, but are not limited to, research and development tax credits recoverable, progress of activities performed by the Contract Resource Organizations (CROs) and Contract Manufacturing Organizations (CMOs) which are used to calculate the research and development expense incurred, and share-based compensation. Accordingly, actual results may differ from those estimates and such differences may be material.
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For The Three and Nine Months Ended September 30, 2021 and 2020 (Unaudited)
(in thousands, except where noted and for share and per share data)
The Company’s significant accounting policies are described in Note 2—Summary of Significant Accounting Policies, in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020. There has been no material change to the significant accounting policies during the nine months ended September 30, 2021, except for the addition of the new policies described below.
Collaborative Arrangements
The Company considers the nature and contractual terms of arrangements and assesses whether an arrangement involves a joint operating activity pursuant to which the Company is an active participant and is exposed to significant risks and rewards dependent on the commercial success of the activity. If the Company is an active participant and is exposed to significant risks and rewards dependent on the commercial success of the activity, the Company accounts for such an arrangement as a collaborative arrangement under Accounting Standards Codification (ASC) 808, Collaborative Arrangements (ASC 808), which requires that certain transactions between the Company and collaborators be recorded in its consolidated statements of comprehensive loss on either a gross basis or net basis, depending on the characteristics of the collaborative relationship, and requires enhanced disclosure of collaborative relationships. The Company evaluates its collaboration agreements for proper classification in its consolidated statements of comprehensive loss based on the nature of the underlying activity. If payments to and from collaborative partners are not within the scope of other authoritative accounting literature, the consolidated statements of loss classification for the payments is based on a reasonable, rational analogy to authoritative accounting literature that is applied in a consistent manner. If the Company concludes that it has a customer relationship with one of its collaborators, the Company follows the guidance in Accounting Standards Codification (ASC) Topic 606, Revenue From Contracts With Customers (ASC 606).
Please refer to note 3, “Revenue” for additional details regarding the Company’s License and Collaboration Agreement (the License Agreement) with Ji Xing Pharmaceuticals, Limited (Ji Xing).
Revenue from Contracts with Customers
In accordance with ASC 606, revenue is recognized when a customer obtains control of promised goods or services. The amount of revenue recognized reflects the consideration to which the Company expects to be entitled in exchange for these goods and services. To achieve this core principle, the Company applies the following five steps: 1) identify the customer contract; 2) identify the contract’s performance obligations; 3) determine the transaction price; 4) allocate the transaction price to the performance obligations; and 5) recognize revenue when or as a performance obligation is satisfied. The Company evaluates all promised goods and services within a customer contract and determines which of such goods and services are separate performance obligations. This evaluation includes an assessment of whether the good or service is capable of being distinct and whether the good or service is separable from other promises in the contract. In assessing whether promised goods or services in licensing arrangements are distinct, the Company considers factors such as the stage of development of the underlying intellectual property and the capabilities of the customer to develop the intellectual property on their own or whether the required expertise is readily available. Licensing arrangements are analyzed to determine whether the promised goods or services, which often include licenses, research and development services and governance committee services, are distinct or whether they must be accounted for as part of a combined performance obligation. If the license is considered not to be distinct, the license would then be combined with other promised goods or services as a combined performance obligation. If the Company is involved in a governance committee, it assesses whether its involvement constitutes a separate performance obligation. When governance committee services are determined to be separate performance obligations, the Company determines the fair value to be allocated to this promised service. Certain contracts contain optional and additional items, which are considered marketing offers and are accounted for as separate contracts with the customer if such option is elected by the customer, unless the option provides a material right which would not be provided without entering into the contract. An option that is considered a material right is accounted for as a separate performance obligation. The transaction price is determined based on the consideration to which the Company will be entitled in exchange for transferring goods and services to the customer. A contract may contain variable consideration, including potential payments for both milestone and research and development services. For certain potential milestone payments, the Company estimates the amount of variable consideration by using the most
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For The Three and Nine Months Ended September 30, 2021 and 2020 (Unaudited)
(in thousands, except where noted and for share and per share data)
likely amount method. In making this assessment, the Company evaluates factors such as the clinical, regulatory, commercial and other risks that must be overcome to achieve the milestone. Each reporting period the Company re-evaluates the probability of achievement of such variable consideration and any related constraints. Milestone will include variable consideration, without constraint, in the transaction price to the extent it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved.
If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price among the performance obligations on a relative standalone selling price basis unless a portion of the transaction price is variable and meets the criteria to be allocated entirely to a performance obligation or to a distinct good or service that forms part of a single performance obligation.
The Company allocates the transaction price based on the estimated standalone selling price of the underlying performance obligations or in the case of certain variable consideration to one or more performance obligations. The Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. The Company utilizes key assumptions to determine the stand-alone selling price, which may include other comparable transactions, pricing considered in negotiating the transaction and the estimated costs to complete the respective performance obligation. Certain variable consideration is allocated specifically to one or more performance obligations in a contract when the terms of the variable consideration relate to the satisfaction of the performance obligation and the resulting amounts allocated to each performance obligation are consistent with the amount the Company would expect to receive for each performance obligation.
When a performance obligation is satisfied, revenue is recognized for the amount of the transaction price, excluding estimates of variable consideration that are constrained, that is allocated to that performance obligation on a relative standalone selling price basis. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations under an arrangement.
For performance obligations consisting of licenses and other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non- refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company will recognize revenue from non-refundable, up-front fees allocated to the license at the point in time when the license is transferred to the customer and the customer is able to use and benefit from the license.
c) Significant Risks and Uncertainties
The COVID-19 pandemic has had an impact on our business, operations and clinical development timelines. Government orders and restrictions in order to control the spread of the disease have impacted patient recruitment, enrollment and follow-up visits at clinical sites. With the global spread of the ongoing COVID-19 pandemic, the Company has implemented business continuity plans designed to address and mitigate the impact of the COVID-19 pandemic on its business. The Company anticipates that the COVID-19 pandemic will continue to have an impact on the development timelines for its clinical programs. The extent to which the COVID-19 pandemic continues to impact its business, its clinical development and regulatory efforts, its corporate development objectives and the value of and market for its common shares will depend on future developments that remain highly uncertain and cannot be predicted with confidence at this time, such as the evolution of new variants, the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S., Europe and other countries, and the effectiveness of actions
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For The Three and Nine Months Ended September 30, 2021 and 2020 (Unaudited)
(in thousands, except where noted and for share and per share data)
taken globally to contain and treat the disease. The global economic slowdown, the overall disruption of global healthcare systems and the other risks and uncertainties associated with the pandemic could have a material adverse effect on the Company’s business, financial condition, results of operations and growth prospects.
In addition, the Company is subject to other challenges and risks specific to its business and its ability to execute on its strategy, as well as risks and uncertainties common to companies in the pharmaceutical industry, including, without limitation, risks and uncertainties associated with: obtaining regulatory approval of its product candidate; delays or problems in the supply of its study drug or failure to comply with manufacturing regulations; identifying, acquiring or in-licensing product candidates; pharmaceutical product development and the inherent uncertainty of clinical success; and the challenges of protecting and enhancing its intellectual property rights; and complying with applicable regulatory requirements.
d) Recent Accounting Pronouncements
The Company has considered recent accounting pronouncements and concluded that they are either not applicable to the business or that the effect is not expected to be material to the unaudited condensed consolidated financial statements as a result of future adoption.
e) Sources of Liquidity and Funding Requirements
The Company has incurred operating losses and has experienced negative operating cash flows since its inception with the and anticipates to continue to incur losses for at least the next several years. As of September 30, 2021, the Company had cash, cash equivalents and short-term investments of $
On May 15, 2021, the Company entered into the License Agreement with Ji Xing, which is an entity affiliated with RTW Investments, LP, (RTW) a beneficial owner of approximately
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For The Three and Nine Months Ended September 30, 2021 and 2020 (Unaudited)
(in thousands, except where noted and for share and per share data)
3 Revenue
General
To date, the Company has not generated revenue from product sales. During the nine months ended September 30, 2021, the Company recognized collaboration revenue of $
In addition to the $
Development | Sales | |||||
Ji Xing License and Collaboration Agreement | $ | | $ | | ||
Total Potential Milestone Payments | $ | | $ | |
Strategic partnerships
Ji Xing
Pursuant to the License Agreement, the Company granted Ji Xing exclusive development and commercialization rights to any pharmaceutical product that uses a device to deliver the Company’s proprietary calcium channel blocker known as etripamil by nasal spray for all prophylactic and therapeutic uses in humans in the Territory.
Ji Xing will be responsible for development and regulatory activities in the Territory, and the Company will remain responsible for certain manufacturing activities in the Territory, subject to the Supply Agreement.
Milestone received a non-refundable upfront cash payment consisting of $
Management evaluated all of the promised goods or services within the contract and determined which such goods and services were separate performance obligations. The Company determined that the license granted was a separate performance obligation as Ji Xing can benefit from the license granted on its own after the transfer of the license, as it does not require any significant development, regulatory or commercialization activities from Milestone. Ji Xing is responsible for all development, regulatory and commercialization activities in the Territory, including the performance of clinical trials necessary for regulatory approval, and is responsible for all such related costs. Supply of the product can be provided by another entity, as Milestone currently uses a CMO for the production of etripamil without subsequent significant modification or customization by the Company, therefore the Company determined the obligation to supply product is a separate and distinct obligation. The Company concluded that the obligation for participation on the various governance committees was distinct as the services could be performed by an outside party, however it was determined to be immaterial after estimating the stand alone cost compared to the License Agreement as a whole. As a result, the Company concluded there were
The Company determined that the transaction price consists of the $
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For The Three and Nine Months Ended September 30, 2021 and 2020 (Unaudited)
(in thousands, except where noted and for share and per share data)
reporting period and as uncertain events are resolved, or other changes in circumstances occur, adjust its estimate of the transaction price if necessary. As of September 30, 2021, the Company has recognized the non-refundable upfront payment as collaboration revenue, for the reasons described in the preceding paragraph.
Concurrent with the License Agreement, Ji Xing acquired $
For any future subsequent purchases of product pursuant to the Supply Agreement, each order will be accounted for as a separate purchase and the order price will be allocated to the products based on the standalone selling price of the products. Under this methodology, the order price will be allocated to the single performance obligation to supply the products. As Milestone has not previously licensed a product for a territory, the residual approach was used by deducting the estimated stand-alone selling price of the other obligations from the total transaction price to determine the stand-alone selling price of the remaining goods and services, which consisted of the transfer of intellectual property pursuant to the license. Therefore, the remaining transaction price of $
4 Short-term investments
Short-term investments are comprised of term deposits issued in US currency. These short-term investments are in scope of ASC 320, Investments - Debt Securities, since the short-term investments maturity is greater than 90 days but less than one year, they are classified as held to maturity, recorded as current assets and are accounted for at amortized cost.
5 Accounts payable and accrued liabilities
Accounts payable and accrued liabilities are comprised of the following:
| September 30, 2021 |
| December 31, 2020 | |||
Trade accounts payable |
| $ | | $ | | |
Accrued compensation and benefits payable |
| | | |||
Accrued research and development liabilities |
| | | |||
Other accrued liabilities |
| | | |||
| $ | | $ | |
6 Shareholders’ equity
Authorized share capital
The Company has authorized and issued common shares, voting and participating, without par value, of which unlimited shares were authorized and
As of September 30, 2021, there were
Additional paid-in capital
12
Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For The Three and Nine Months Ended September 30, 2021 and 2020 (Unaudited)
(in thousands, except where noted and for share and per share data)
Three months ended September 30, | Nine months ended September 30, | ||||||||||||
2021 |
| 2020 | 2021 |
| 2020 | ||||||||
Opening balance | $ | |
| $ | $ | |
| $ | | ||||
Share-based compensation expense | |
| |
| | ||||||||
Exercise of stock options | ( |
| ( | ( |
| ( | |||||||
Closing balance | $ | |
| $ | | $ | |
| $ | |
Pre-funded warrants
On May 15, 2021, the Company entered into a securities purchase agreement to sell and issue in a private placement pre-funded warrants to purchase up to
7 Share Based Compensation
Under the Company’s 2019 Equity Incentive Plan (the 2019 Plan) and the Company’s Stock Option Plan (the 2011 Plan), unless otherwise decided by the Board of Directors, options vest and are exercisable as follows:
On January 1, 2021, the number of the Company’s common shares reserved for issuance under the 2019 Plan increased by
The total outstanding and exercisable options from the 2011 Plan and 2019 Plan as of September 30 were as follows:
2021 | 2020 | |||||||||||||||||||||
Weighted | Weighted | |||||||||||||||||||||
Number | average | Number | average | |||||||||||||||||||
of shares | exercise | of shares | exercise | |||||||||||||||||||
| 2019 Plan |
| 2011 Plan |
| Total |
| price |
| 2019 Plan |
| 2011 Plan |
| Total |
| price | |||||||
Outstanding at beginning of year - 2011 Plan |
| — | | | $ | |
| — | | | $ | | ||||||||||
Outstanding at beginning of year - 2019 Plan | | — | | | | — | | | ||||||||||||||
Granted - 2019 Plan | | — | | | | — | | | ||||||||||||||
Exercised - 2011 Plan | — | ( | ( | | — | ( | ( | | ||||||||||||||
Exercised - 2019 Plan | ( | — | ( | | — | — | — | — | ||||||||||||||
Forfeited - 2011 Plan |
| — | — | — | — |
| — | ( | ( | | ||||||||||||
Forfeited - 2019 Plan | ( | — | ( | | ( | — | ( | | ||||||||||||||
Cancelled - 2019 Plan | ( | — | ( | |
| ( | — | ( | | |||||||||||||
Outstanding at end of period |
| | | | $ | |
| | | | $ | | ||||||||||
Outstanding at end of period - Weighted average exercise price | $ | | $ | | $ | | $ | | ||||||||||||||
Exercisable at end of period | | | | $ | | | | | $ | | ||||||||||||
Exercisable at end of period - Weighted average exercise price |
| $ | | $ | |
| $ | | $ | |
13
Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For The Three and Nine Months Ended September 30, 2021 and 2020 (Unaudited)
(in thousands, except where noted and for share and per share data)
The weighted average remaining contractual life was
There was $
Options granted are valued using the Black-Scholes option pricing model. Amortization of the fair value of the options over vesting years has been expensed and credited to additional paid-in capital in shareholders’ equity.
The non-vested options as of September 30 were as follows:
2021 | 2020 | ||||||||||||||||||
Number | Weighted | Number | Weighted | ||||||||||||||||
of options | average | of options | average | ||||||||||||||||
| 2019 Plan | 2011 Plan |
| Total |
| fair value |
|
| 2019 Plan | 2011 Plan |
| Total |
| fair value | |||||
Non-vested share options at beginning of year - 2011 Plan |
| — | | |
| $ | |
|
| — | | |
| $ | | ||||
Non-vested share options at beginning of year - 2019 Plan | | — | |
| $ | | | — | |
| $ | | |||||||
Granted - 2019 Plan |
| | — | | |
| | — | | | |||||||||
Vested, outstanding 2011 Plan | — | ( | ( |
| |
| — | ( | ( |
| | ||||||||
Vested, outstanding 2019 Plan | ( | — | ( | | ( | — | ( | | |||||||||||
Forfeited - 2011 Plan |
| — | — | — |
| — |
|
| — | ( | ( |
| | ||||||
Forfeited - 2019 Plan | ( | — | ( | | ( | — | ( | | |||||||||||
Non-vested share options at end of period |
| | | |
| $ | |
|
| | | |
| $ | | ||||
Non-vested share options at end of period - Weighted average fair value | $ | | $ | | $ | | $ | |
The fair value of share-based payment transaction is measured using Black-Scholes valuation model. This model also requires assumptions, including expected option life, volatility, risk-free interest rate and dividend yield, which greatly affect the calculated values.
The fair value of options granted was estimated using the Black-Scholes option pricing model, resulting in the following weighted average assumptions for the options granted:
Three months ended September 30, | Nine months ended September 30, | ||||||||||||
2021 |
| 2020 |
| 2021 |
| 2020 |
| ||||||
Exercise price | $ | |
| $ | — | $ | |
| $ | | |||
Share price | $ | |
| $ | — | $ | |
| $ | | |||
Volatility |
| | % | — | % |
| | % | | % | |||
Risk-free interest rate |
| | % | — | % |
| | % | | % | |||
Expected life |
|
| — |
|
| ||||||||
Dividend |
| % | — | % |
| % | % |
Expected volatility is determined using comparable companies for which the information is publicly available. The risk-free interest rate is determined based on the U.S. sovereign rates benchmark in effect at the time of grant with a remaining term equal to the expected life of the option. Expected option life is determined based on the simplified method as the Company does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate expected term. The simplified method is an average of the contractual term of the options and its ordinary vesting period. Dividend yield is based on the share option’s exercise price and expected annual dividend rate at the time of grant.
14
Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For The Three and Nine Months Ended September 30, 2021 and 2020 (Unaudited)
(in thousands, except where noted and for share and per share data)