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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2021

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: 001-38899

Milestone Pharmaceuticals Inc.

(Exact Name of Registrant as Specified in its Charter)

Québec

    

Not applicable

(State or other jurisdiction of
incorporation or organization)

(I.R.S. Employer
Identification No.)

1111 Dr. Frederik-Philips Boulevard, Suite 420

Montréal, Québec CA H4M 2X6

(514) 336-0444

(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:

Title of each class

    

Trading Symbol(s)

    

Name of each exchange on which registered

Common Shares

MIST

The Nasdaq Stock Market LLC

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.    Yes      No  

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).    Yes      No  

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

Non-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      No  

As of November 4th, 2021, the registrant had 29,872,535 common shares, no par value per share, outstanding.

Table of Contents

Table of Contents

Page

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

1

PART I.

FINANCIAL INFORMATION

3

Item 1.

Financial Statements (Unaudited)

3

Condensed Consolidated Balance Sheets

3

Condensed Consolidated Statements of Loss

4

Condensed Consolidated Statements of Shareholders’ Equity

5

Condensed Consolidated Statements of Cash Flows

6

Notes to Unaudited Condensed Consolidated Financial Statements

7

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

16

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

28

Item 4.

Controls and Procedures

28

PART II.

OTHER INFORMATION

29

Item 1.

Legal Proceedings

29

Item 1A.

Risk Factors

29

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

29

Item 3.

Defaults Upon Senior Securities

29

Item 4.

Mine Safety Disclosures

29

Item 5.

Other Information

29

Item 6.

Exhibits

30

Table of Contents

“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;

1

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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.

2

Table of Contents

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

  

 

  

Current assets

  

 

  

Cash and cash equivalents

$

111,426

 

$

72,310

Short-term investment (note 4)

15,000

70,000

Research and development tax credits receivable

275

 

725

Prepaid expenses

5,968

 

5,428

Other receivables

89

 

223

Total current assets

132,758

 

148,686

Operating lease assets

780

980

Property and equipment

238

 

308

Total assets

$

133,776

 

$

149,974

Liabilities, and Shareholders' Equity

  

 

  

Current liabilities

  

 

  

Accounts payable and accrued liabilities (note 5)

$

5,593

 

$

5,914

Operating lease liabilities

254

 

245

Total current liabilities

5,847

 

6,159

Operating lease liabilities (net of current portion)

512

 

696

Total liabilities

6,359

 

6,855

Shareholders’ Equity (note 6, note 7)

  

 

  

Common shares, no par value, unlimited shares authorized 29,869,785 shares issued and outstanding as of September 30, 2021, 29,827,997 shares issued and outstanding as of December 31, 2020

251,766

 

251,682

Pre-funded warrants - 12,327,780 issued and outstanding as of September 30, 2021 and 11,417,034 as of December 31, 2020

52,927

48,007

Additional paid-in capital

13,793

 

8,530

Cumulative translation adjustment

(1,634)

 

(1,634)

Accumulated deficit

(189,435)

 

(163,466)

Total shareholders’ equity

127,417

 

143,119

Total liabilities and shareholders’ equity

$

133,776

 

$

149,974

The accompanying notes are an integral part of these interim condensed consolidated financial statements.

3

Table of Contents

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)

$

 

$

$

15,000

 

$

Operating expenses

 

 

  

 

Research and development, net of tax credits

 

9,733

 

8,228

27,755

 

28,722

General and administrative

 

2,961

 

2,952

8,612

 

8,611

Commercial

 

1,579

 

905

4,788

 

4,615

Loss from operations

 

(14,273)

 

(12,085)

(26,155)

 

(41,948)

Interest income, net

 

48

 

89

186

 

630

Loss before income taxes

(14,225)

(11,996)

(25,969)

(41,318)

Income tax benefit

 

17

 

17

Net loss

 

$

(14,225)

 

$

(11,979)

$

(25,969)

 

$

(41,301)

Weighted average number of shares and pre-funded warrants outstanding, basic & diluted

42,182,887

29,774,065

41,707,563

26,329,581

Net loss per share, basic and diluted (note 8)

 

$

(0.34)

 

$

(0.40)

$

(0.62)

 

$

(1.57)

The accompanying notes are an integral part of these interim condensed consolidated financial statements.

4

Table of Contents

Milestone Pharmaceuticals Inc.

Condensed Consolidated Statements of Shareholders’ Equity (Unaudited)

(in thousands, except share data)

Common Shares

Pre-funded warrants

    

Number
of shares

    

Amount

    

Number
of warrants

    

Amount

    

Additional
paid-in
capital

    

Cumulative
translation
adjustment

    

Accumulated
deficit

    

Total

Balance as of June 30, 2020

24,692,953

$

226,676

$

$

5,795

$

(1,634)

$

(142,821)

$

88,016

Transactions in three-month period ended September 30, 2020

Net loss

(11,979)

(11,979)

Exercise of stock options

34,047

82

(34)

48

Share-based compensation

1,343

1,343

Pre-funded warrants - Private Placement

6,655,131

24,770

24,770

Balance as of September 30, 2020

24,727,000

$

226,758

6,655,131

$

24,770

$

7,104

$

(1,634)

$

(154,800)

$

102,198

Balance as of June 30, 2021

29,846,000

$

251,716

12,327,780

$

52,927

$

11,795

$

(1,634)

$

(175,210)

$

139,594

Transactions in three-month period ended September 30, 2021

Net income

(14,225)

(14,225)

Exercise of stock options (note 7)

23,785

50

(26)

24

Private Placement (note 7)

Share-based compensation (note 7)

2,024

2,024

Balance as of September 30, 2021

29,869,785

$

251,766

12,327,780

$

52,927

$

13,793

$

(1,634)

$

(189,435)

$

127,417

Common Shares

Pre-funded warrants

    

Number
of shares

    

Amount

    

Number
of warrants

    

Amount

    

Additional
paid-in
capital

    

Cumulative
translation
adjustment

    

Accumulated
deficit

    

Total

Balance as of December 31, 2019

24,505,748

$

226,245

$

$

3,805

$

(1,634)

$

(113,499)

$

114,917

Transactions in nine-month period ended September 30, 2020

Net loss

(41,301)

(41,301)

Exercise of stock options

221,252

513

(216)

297

Share-based compensation

3,515

3,515

Pre-funded warrants - Private Placement

6,655,131

24,770

24,770

Balance as of September 30, 2020

24,727,000

$

226,758

6,655,131

$

24,770

$

7,104

$

(1,634)

$

(154,800)

$

102,198

Balance as of December 31, 2020

29,827,997

$

251,682

11,417,034

$

48,007

$

8,530

$

(1,634)

$

(163,466)

$

143,119

Transactions in nine-month period ended September 30, 2021

Net income

(25,969)

(25,969)

Exercise of stock options (note 7)

41,788

84

(41)

43

Private Placement (note 7)

910,746

4,920

4,920

Share-based compensation (note 7)

5,304

5,304

Balance as of September 30, 2021

29,869,785

$

251,766

12,327,780

$

52,927

$

13,793

$

(1,634)

$

(189,435)

$

127,417

The accompanying notes are an integral part of these interim condensed consolidated financial statements.

5

Table of Contents

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

$

(25,969)

$

(41,301)

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation of property and equipment

70

72

Share-based compensation expense (note 7)

5,304

3,515

Changes in operating assets and liabilities:

Other receivables

134

75

Research and development tax credits receivable

450

(244)

Prepaid expenses

(540)

(1,659)

Operating lease assets and liabilities

25

(83)

Accounts payable and accrued liabilities

(321)

(2,350)

Net cash used in operating activities

(20,847)

(41,975)

Cash provided by (used in) investing activities

Acquisition of short-term investments

(15,000)

(60,000)

Redemption of short-term investments

70,000

4,000

Net cash provided by (used in) investing activities

55,000

(56,000)

Cash provided by financing activities

Proceeds from exercise of options (note 7)

43

297

Proceeds from issuance of pre-funded warrants, net of issuance cost (note 6)

4,920

24,770

Cash provided by financing activities

4,963

25,067

Net increase (decrease) in cash and cash equivalents

39,116

(72,908)

Cash and cash equivalents – Beginning of period

72,310

119,818

Cash and cash equivalents – End of period

$

111,426

$

46,910

The accompanying notes are an integral part of these interim condensed consolidated financial statements.

6

Table of Contents

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 $126.4 million and an accumulated deficit of $189.4 million.

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 14% of the Company’s common shares. Under 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 following territories: People’s Republic of China, including mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, and Taiwan (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 subsequently entered into by the Company and Ji Xing as contemplated by the License Agreement (the Supply Agreement).  The Company received a non-refundable upfront cash payment of $15 million (see note 3) and the right to future payments of up to $107.5 million in total development and sales milestone payments. In addition, the Company is entitled to receive tiered royalty payments ranging from a percentage in the low double digits to the high double digits of Net Sales (as defined in the License Agreement) of all products sold in the Territory.

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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 $15 million, in the form of a non-refundable upfront cash payment in connection with the License Agreement, explained in more detail below.  

In addition to the $15 million of non-refundable upfront cash payments already received, the Company has the potential to earn the following additional future milestone payments:

Development
Milestones

Sales
Milestones

Ji Xing License and Collaboration Agreement

$

15,500

$

92,000

Total Potential Milestone Payments

$

15,500

$

92,000

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 $15 million, and the right to receive up to $107.5 million in future milestone payments and royalties on any sales of etripamil in the Territory.

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 two material and distinct performance obligations to account for under ASC 606 at the inception of the License Agreement.

The Company determined that the transaction price consists of the $15 million non-refundable upfront cash payment and the constrained variable consideration of the development milestone payments. As the development milestones are contingent on occurrences out of the direct control of the Company, the estimate of the variable consideration is $0.  Variable constraint does not apply to sales- or usage-based royalties derived from the licensing of Intellectual property; rather, consideration from such royalties is only recognized as revenue at the later of when the performance obligation is satisfied or when the uncertainty is resolved (e.g., when subsequent sales or usage occurs), therefore the sales and royalty milestones are not included in the transaction price. The Company will re-evaluate the transaction price at the end of each

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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 $5 million of pre-funded warrants (see note 6). The Company considered whether this equity investment should be evaluated  as part of the transaction price, and concluded that as the fair value of the company’s common shares on a per share basis was equal to the fair value of the pre-funded warrants at the date of the investment, there was no premium or discount on the shares that should be allocated and included in the transaction price. The Company accounted for the issuance of pre-funded warrants as equity and included in basic and diluted loss per share in the accompanying financial statements. See note 6 for additional details.

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 $15 million was allocated to the technology transfer and recognized at a point in time when the technology has been transferred.  The technology transfer was completed on June 22, 2021, and the $15 million was recognized at that point in time as collaboration revenue in the related statement of comprehensive loss.

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

 

$

4,200

$

4,641

Accrued compensation and benefits payable

 

1,016

957

Accrued research and development liabilities

 

38

152

Other accrued liabilities

 

339

164

 

$

5,593

$

5,914

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 29,869,785 shares were issued and outstanding as of September 30, 2021.

As of September 30, 2021, there were 822,100 common shares available for issuance under the Employee Stock Purchase Plans and no common shares have been issued under such plan.

Additional paid-in capital

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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)

Three months ended September 30, 

Nine months ended September 30, 

2021

    

2020

2021

    

2020

Opening balance

$

11,795

 

$

5,795

$

8,530

 

$

3,805

Share-based compensation expense

2,024

 

1,343

5,304

 

3,515

Exercise of stock options

(26)

 

(34)

(41)

 

(216)

Closing balance

$

13,793

 

$

7,104

$

13,793

 

$

7,104

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 910,746 of the Company’s common shares, at a purchase price of $5.48 per pre-funded warrant pursuant to the License Agreement for aggregate net proceeds of $4.9 million (the Private Placement).  The Private Placement closed on May 21, 2021. Each pre-funded warrant is exercisable for one of the Company’s common shares at an exercise price of $0.01 per share, has no expiration date, and is immediately exercisable, subject to certain beneficial ownership limitations. The pre-funded warrants are classified and accounted for as equity.

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: 25% vest and are exercisable on the one year anniversary of the grant date and one thirty-sixth (1/36th) of the remaining options vest and are exercisable each month thereafter, such that options are vested in full on four-year anniversary of the grant date.

On January 1, 2021, the number of the Company’s common shares reserved for issuance under the 2019 Plan increased by 1,193,119 common shares. In addition, 72,186 options have been forfeited under the 2011 Plan after adoption of the 2019 Plan and became available for issuance under the 2019 Plan. As of September 30, 2021, there were 4,566,467 shares available for issuance under the 2019 Plan, of which 806,126 shares were available for future grants.

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

 

2,080,087

2,080,087

$

2.15

 

2,364,526

2,364,526

$

2.15

Outstanding at beginning of year - 2019 Plan

1,706,190

1,706,190

13.55

220,140

220,140

20.78

Granted - 2019 Plan

2,065,200

2,065,200

6.24

1,474,460

1,474,460

12.91

Exercised - 2011 Plan

(40,538)

(40,538)

0.97

(221,252)

(221,252)

1.34

Exercised - 2019 Plan

(1,250)

(1,250)

3.74

Forfeited - 2011 Plan

 

 

(28,478)

(28,478)

2.57

Forfeited - 2019 Plan

(13,882)

(13,882)

12.81

(37,913)

(37,913)

21.46

Cancelled - 2019 Plan

(1,167)

(1,167)

21.48

 

(2,997)

(2,997)

21.48

Outstanding at end of period

 

3,755,091

2,039,549

5,794,640

$

6.94

 

1,653,690

2,114,796

3,768,486

$

7.30

Outstanding at end of period - Weighted average exercise price

$

9.53

$

2.18

$

13.78

$

2.23

Exercisable at end of period

938,433

1,764,146

2,702,579

$

5.39

155,501

1,445,244

1,600,745

$

2.77

Exercisable at end of period - Weighted average exercise price

 

$

11.61

$

2.08

 

$

10.11

$

1.99

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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 weighted average remaining contractual life was 8.0 and 8.2 years for outstanding options as of September 30, 2021 and 2020, respectively. The weighted average remaining contractual life was 6.9 and 7.2 years for vested options, as of September 30, 2021 and 2020, respectively.

There was $17,318 and $17,847 total unrecognized compensation cost related to non-vested share options as of September 30, 2021 and 2020, respectively. The share options are expected to be recognized over a remaining weighted average vesting period of 2.6 years and 2.4 years as of September 30, 2021 and 2020, respectively.

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

 

543,192

543,192

 

$

1.81

 

 

1,152,300

1,152,300

 

$

1.88

Non-vested share options at beginning of year - 2019 Plan

1,438,026

1,438,026

 

$

10.28

218,975

218,975

 

$

14.44

Granted - 2019 Plan

 

2,065,200

2,065,200

4.71

 

1,471,463

1,471,463

9.13

Vested, outstanding 2011 Plan

(267,789)

(267,789)

 

1.64

 

(454,270)

(454,270)

 

1.87

Vested, outstanding 2019 Plan

(672,686)

(672,686)

9.17

(154,336)

(154,336)

6.99

Forfeited - 2011 Plan

 

 

 

 

(28,478)

(28,478)

 

1.84

Forfeited - 2019 Plan

(13,882)

(13,882)

9.18

(37,913)

(37,913)

15.21

Non-vested share options at end of period

 

2,816,658

275,403

3,092,061

 

$

6.07

 

 

1,498,189

669,552

2,167,741

 

$

7.48

Non-vested share options at end of period - Weighted average fair value

$

6.47

$

1.98

$

9.97

$

1.90

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

$

5.96

 

$

$

6.24

 

$

12.91

Share price

$

5.96

 

$

$

6.24

 

$

12.91

Volatility

 

94

%  

%

 

94

%  

84

%

Risk-free interest rate

 

0.94

%  

%

 

1.04

%  

1.06

%

Expected life

 

6.08

 

 

6.01

 

5.89

Dividend

 

0

%  

%

 

0

%  

0

%

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.

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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 recognized share-based compensation expense as follows: