EX-99.27 28 d805932dex9927.htm EX-99.27 EX-99.27

Exhibit 99.27

 

LOGO

MANAGEMENT’S DISCUSSION AND ANALYSIS

FOR THE SIX-MONTH PERIOD ENDED MAY 31, 2018

The following Management’s Discussion and Analysis, or MD&A, provides Management’s comments on the financial position and results of operations of Theratechnologies Inc., on a consolidated basis, for the three- and six-month periods ended May 31, 2018 as compared to the three- and six-month periods ended May 31, 2017. Unless otherwise indicated or unless the context requires otherwise, all references in this MD&A to “Theratechnologies”, the “Company”, the “Corporation”, “we”, “our”, “us” or similar terms refer to Theratechnologies Inc. and its subsidiaries on a consolidated basis. This MD&A is dated July 3, 2018, was approved by our Audit Committee on July 4, 2018, and should be read in conjunction with our unaudited interim consolidated financial statements and the notes thereto as at May 31, 2018, or Interim Financial Statements, as well as the MD&A and audited annual consolidated financial statements, including the notes thereto, as at November 30, 2017. The Interim Consolidated Financial Statements for the three- and six-month periods ended May 31, 2018 have not been reviewed by our auditors.

Except as otherwise indicated, the financial information contained in this MD&A and in our audited consolidated financial statements has been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB.

The Company’s functional currency is the United States dollar, or USD, because the vast majority of its operational activities and sales occur in the United States. However, since we believe that Canadian dollar currency, or CAD, is more useful to users of these documents, except where otherwise indicated, all monetary amounts set forth in this MD&A and the Interim Financial Statements and the notes thereto are expressed in CAD for reporting purposes. The average and closing exchange rates for the second quarter of fiscal 2018 (CAD equivalents of 1 USD) were 1.2843 and 1.2955 respectively, compared to 1.3475 and 1.3510 for the second quarter of fiscal 2017. In accordance with IFRS, the exchange difference arising from the translation of our USD-denominated financial statements to CAD for reporting purposes is included in “accumulated other comprehensive income”. References to $ and C$ are to CAD and references to US$ are to USD.

In this MD&A, the use of EGRIFTA® refers to tesamorelin for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy and TrogarzoTM (ibalizumab-uiyk) injection refers to ibalizumab for the treatment of multidrug resistant HIV-1 infected patients.

This MD&A contains information that we believe may affect our prospective financial condition, cash flows and results of operations. Readers are cautioned to consult the section, “Forward-Looking Information”, below.

Business Overview

We are a specialty pharmaceutical company addressing unmet medical needs to promote healthy living and an improved quality of life among HIV patients.

 

Theratechnologies Inc.

2015 Peel, 5th Floor

Montreal, Quebec H3A 1T8

  


Our business strategy is to build a portfolio of complementary products, compatible with our expertise and our commercial platform, that will fuel sustainable revenue and cash flow growth and build value for our shareholders.

Our first product, EGRIFTA® (tesamorelin for injection), was approved by the United States Food and Drug Administration, or FDA, in November 2010, by Health Canada in March 2015, and by COFEPRIS, Mexico’s health agency, in March 2016. It is, to date, the only approved therapy for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. We have established an integrated commercial platform to market EGRIFTA® in the United States and Canada. We also have agreements in place for the distribution and commercialization of EGRIFTA® in markets outside of the United States and Canada. In all cases, our commercial partners are responsible for the distribution and marketing of EGRIFTA®, if approved. However, we no longer view those markets as material to grow our revenues.

In March 2016, we entered into an agreement with TaiMed Biologics, Inc., or TaiMed, to acquire the commercial rights to Trogarzo for the United States and Canada, or TaiMed Agreement.

In March 2017, the TaiMed Agreement was amended to include the commercial rights to ibalizumab in the European Union countries and in other countries such as Israel, Norway, Russia and Switzerland.

Trogarzo is a humanized monoclonal antibody and is indicated for the treatment of human immunodeficiency virus type 1, or HIV-1, infection in heavily treatment-experienced adults with multidrug resistant, or MDR, HIV-1 infection failing their current antiretroviral regimen.

Trogarzo was approved by the FDA on March 6, 2018 and has been commercially available since April 30, 2018.

Since the second half of fiscal 2017, we have been working on building the foundation for ibalizumab in Europe to achieve marketing approval in a timely and efficient manner.

Fiscal 2018 Business Plan Update

Consolidated revenue for the three-month period ended May 31, 2018 was $12,326,000 compared to $10,016,000 for the same period ended May 31, 2017, representing an increase of 23.1%.

Second quarter results demonstrate the sustained positive impact of the expanded sales force on EGRIFTA® revenues even though the exchange rate between the U.S. and Canadian dollars was not favourable given that revenues are reported in Canadian dollars.

Trogarzo has been commercially available in the United States since April 30, 2018 which allowed Theratechnologies to record its first revenues from Trogarzo.

Obtaining patient access to Trogarzo remains a key priority for Theratechnologies and our managed market team which has been diligently working with public and private payers to facilitate formulary inclusion. As of the date hereof, 48% of privately and publicly covered lives in the United States had access to Trogarzo.

 

Theratechnologies Inc.

2015 Peel, 5th Floor

Montreal, Quebec H3A 1T8

   2


Since early April, Theratechnologies’ sales team has met with more than 2,000 physicians across the United States. In many cases, physicians have received more than one visit from one of our key account managers.

As we develop the United States market for Trogarzo, we will also continue to work towards securing European marketing authorization through the centralized approval procedure. As part of our preparatory work in Europe, technical meetings with representatives from the rapporteur and co-rapporteur countries took place in April 2018. Based on those meetings, Theratechnologies has been permitted to seek regulatory approval from the European Medicines Agency, or EMA, for Trogarzo using efficacy and safety data from the clinical trials submitted to the FDA.

In September 2016, we announced that we were moving forward with the development of a single-vial formulation of EGRIFTA®, or F4 Formulation. EGRIFTA® currently comes in two vials. Presented in a single daily vial, the F4 Formulation has the advantage of being four times more concentrated, thus significantly reducing the volume of administration. The F4 Formulation has also previously been shown to be stable at room temperature, which would be a significant improvement as refrigeration by pharmacies and patients would no longer be required. The necessary F4 Formulation bioequivalence studies and additional stability testing have now been completed and show bioequivalence to the current 1mg formulation. The supplemental New Drug Application, or sNDA, for the new formulation was submitted to the FDA on July 3, 2018.

Adjusted EBITDA in the second quarter of fiscal 2018 was $(1,054,000) compared to $(3,739,000) in the second quarter of fiscal 2017. We use adjusted EBITDA to measure cash flow generation. See “Non-IFRS Financial Measures” below.

Revenue

(in thousands of Canadian dollars)

 

     Three-month
periods ended
May 31,
     Six-month
periods ended
May 31,
 
     2018      2017      2018      2017  

Net Sales

     12,326        10,015        22,543        19,049  

Royalties

     —          1        1        2  
  

 

 

    

 

 

    

 

 

    

 

 

 

Revenue

     12,326        10,016        22,544        19,051  
  

 

 

    

 

 

    

 

 

    

 

 

 

Consolidated revenue for the three- and six-month periods ended May 31, 2018 was $12,326,000 and $22,544,000 compared to $10,016,000 and $19,051,000 for the same periods ended May 31, 2017, an increase of 23.1% and 18.3% respectively. Revenue growth for the last quarter compared to the same quarter last year reflects the added contribution of Trogarzo.

 

Theratechnologies Inc.

2015 Peel, 5th Floor

Montreal, Quebec H3A 1T8

   3


Net sales of EGRIFTA® were our strongest ever for a second quarter. EGRIFTA® net sales revenue was $11,140,000 in the second quarter of fiscal 2018, compared to $10,015,000 in the second quarter of the prior year, representing an increase of 11.2%. In USD, net EGRIFTA® sales in the second quarter of fiscal 2018 were $8,674,000 compared to $7,432,000 in the second quarter of fiscal 2017, an increase of 16.7%.

Trogarzo has been commercially available in the United States since April 30, 2018 which allowed Theratechnologies to record its first revenues from Trogarzo. For the second quarter of 2018, Trogarzo revenues amounted to $1,186,000 or US$924,000.

Cost of Sales

For the three- and six-month periods ended May 31, 2018, cost of sales was $2,789,000 and $4,935,000 compared to $2,041,000 and $4,091,000 in the comparable periods of fiscal 2017. Cost of goods sold was $2,049,000 and $3,234,000 compared to $1,179,000 and $2,265,000 for the same periods last year. The increase in cost of goods sold is mainly due to the introduction of Trogarzo.

Cost of sales also includes royalties due under the terms of the agreement terminating the collaboration and licensing agreement with EMD Serono, Inc (the “Termination Agreement”). In the three- and six-month periods of 2018, royalties recorded on EGRIFTA® sales amounted to $578,000 and $1,699,000 as compared to $987,000 and $1,773,000 during the same periods in 2017.

R&D Expenses

R&D expenses in the three- and six-month periods ended May 31, 2018 amounted to $2,436,000 and $4,834,000 compared to $3,654,000 and $5,674,000 in the comparable periods of fiscal 2017.

Several factors contributed to the lowering of R&D expenses including costs associated with two Phase 4 clinical trials, which amounted to $351,000 and $768,000 in the three- and six-month periods ended May 31, 2018 compared to $632,000 and $1,079,000 in the comparable periods of fiscal 2017. On May 1, 2018, Theratechnologies announced that it had been released from its last post-approval commitments by the FDA (see note 25(e) of our audited annual consolidated financial statements for the year ended November 30, 2017).

The reduction in R&D expenses is also explained by a decrease in medical affairs initiatives as the approval of Trogarzo shifted more focus towards marketing initiatives. Costs associated with the development of the F4 Formulation were also down significantly in the second quarter of 2018 compared to the same quarter last year which, at the time, included a non-recurring expense for a product batch required for the bioequivalence study. R&D expenses also include regulatory affairs activities, such as preparation for the European filing of Trogarzo, quality assurance and medical affairs initiatives for EGRIFTA®.

Selling and Market Development Expenses

Selling and market development expenses in the three- and six-month periods ended May 31, 2018 amounted to $7,651,000 and $14,344,000 compared to $7,191,000 and $10,958,000 in the comparable periods of fiscal 2017. While this item is slightly more compared to the same period last year, it is mostly stable quarter over quarter.

 

Theratechnologies Inc.

2015 Peel, 5th Floor

Montreal, Quebec H3A 1T8

   4


Compared to the same quarter last year, selling and market development expenses in the second quarter of fiscal 2018 were impacted by higher spending to prepare the commercialization strategy of Trogarzo in Europe as well as expenses related to the launch meeting held in Montreal to train our sales force after the approval of Trogarzo by the FDA. Selling and market development expenses also include promotion of EGRIFTA® and Trogarzo in the territories where they are approved.

Amortization of the intangible asset value established for the EGRIFTA® and Trogarzo, since April 30, 2018, commercialization rights is also included in selling and market development expenses. We recorded an expense of $532,000 and $1,008,000 in the three- and six-month periods ended May 31, 2018 compared to $509,000 and $1,008,000 in the prior-year periods.

General and Administrative Expenses

General and administrative expenses in the three- and six-month periods ended May 31, 2018 amounted to $1,642,000 and $3,155,000 compared to $1,698,000 and $2,932,000 reported in the comparable periods of fiscal 2017.

Finance Income

Finance income, consisting of interest income, for the three- and six-month periods ended May 31, 2018 was $100,000 and $200,000 compared to $84,000 and $149,000 in the comparable periods of fiscal 2017.

Finance Costs

Finance costs for the three- and six-month periods ended May 31, 2018 were $368,000 and $563,000 compared to $4,625,000 and $6,897,000 in the comparable periods of fiscal 2017. Finance costs no longer include losses related to the change in the fair value of warrant liability ($4,020,000 in the second quarter of 2017) as the last outstanding warrants were exercised in the third quarter of 2017.

Accretion expense on the long-term obligation was $242,000 and $524,000 for the three- and six-month periods of 2018 compared to $384,000 and $802,000 for the same periods last year, reflecting the lower outstanding balance during these periods.

Adjusted EBITDA

Adjusted EBITDA for the three- and six- month periods ended May 31, 2018 was $(1,054,000) and $(3,075,000) compared to $(3,739,000) and $(3,014,000) in the comparable periods of fiscal 2017. See “Non-IFRS Financial Measures” below.

Net Loss

Taking into account the revenue and expense variations described above, we recorded a net loss of $2,460,000 or $(0.03) per share in the second quarter of fiscal 2018 and a net loss of $5,087,000 or $(0.07) per share for the six-month period ended May 31,2018 compared a net loss of $9,109,000 or $(0.12) per share in the three months ended May 31, 2017 and a net loss of $11,352,000 or $(0.16) per share compared for the six-month period ended May 31, 2017.

 

Theratechnologies Inc.

2015 Peel, 5th Floor

Montreal, Quebec H3A 1T8

   5


Financial Position

For the three- and six-month periods ended May 31, 2018, cash flow used in operating activities was $(4,128,000) and $(5,273,000) compared to $(88,000) and $2,472,000 for the same periods last year.

In the second quarter of fiscal 2018, changes in operating assets and liabilities had a negative impact on cash flow of $(2,714,000). These changes include an increase in trade and other receivables of $3,498,000 as a result of higher sales and a $2,113,000 increase in accounts payable and accrued liabilities.

In the first six months of fiscal 2018, changes in operating assets and liabilities negatively affected cash flow by $1,213,000 compared to an increase in cash flow of $5,761,000 in the comparable period of fiscal 2017. As was the case in the second quarter of fiscal 2017, the most significant changes were a decrease in trade and other receivables of $369,000, and decreased accounts payable and accrued liabilities of $425,000.

In the second quarter of 2018, the Company received cash consideration of $122,000 for the exercise of broker options and $284,000 for stock options exercised during the period.

Financing activities in the second quarters of fiscal 2018 and fiscal 2017 also included scheduled payments against the long-term obligation of US$4,000,000 ($5,137,000 in fiscal 2018 compared to $5,390,000 in fiscal 2017).

As at May 31, 2018, cash, cash equivalents and bonds amounted to $24,149,000 compared to $32,929,900 at November 30, 2017.

 

Theratechnologies Inc.

2015 Peel, 5th Floor

Montreal, Quebec H3A 1T8

   6


Quarterly Financial Information

The following table is a summary of our unaudited consolidated operating results for the last eight quarters.

(In thousands of dollars, except per share amounts)

 

     2018                       2017                  2016  
     Q2     Q1     Q4     Q3     Q2     Q1     Q4      Q3  

Net sales

     12,326       10,217       12,595       11,217       10,015       9,034       10,376        8,924  

Royalties and license fees

     —         1       1       —         1       1       1        1  

Revenue

     12,326       10,218       12,596       11,217       10,016       9,035       10,377        8,925  

Net (loss) profit

     (2,460     (2,627     (4,216     (2,882     (9,109     (2,243     173        888  

Basic and diluted (loss) earnings per share

     (0.03     (0.04     (0.06     (0.04     (0.12     (0.03     —          0.01  

The issuance of common share purchase warrants in 2015 has had a significant effect on quarterly earnings. Variations in the fair value of the warrant liability, a non-cash item, resulted in the following gains and losses: 2017 – (Q1) a loss of $1,909,000, (Q2) a loss of $4,020,000, (Q3) a loss of $725,000, (Q4) no impact; 2016, (Q3) a gain of $782,000, (Q4) a loss of $805,000.

Factors Affecting the Variability of Quarterly Results

There are quarter-over-quarter variations in net sales revenue, principally due to changes in distributor inventory levels with some additional impact from time to time related to average net selling price, which is affected by changes in the mix of private payors versus government drug reimbursement plans.

CAD/USD currency fluctuations also have an effect when sales figures are converted to CAD for reporting purposes. Since regaining commercial rights to EGRIFTA®, sales have kept an overall upward trend as measured by unit sales and dollar value.

In the second quarter of fiscal 2017, the Company undertook a major expansion of its U.S. sales organization and added staffing to its medical science liaison and managed markets groups in order to cover additional territories and prepare for the potential launch of ibalizumab in the United States. As a result, EGRIFTA® patient numbers and, consequently, quarter over quarter sales have since been growing strongly. The Company views this initiative as a sound long-term investment in its future growth. However, in the short term, the related additional expenses have negatively affected earnings as illustrated above.

 

Theratechnologies Inc.

2015 Peel, 5th Floor

Montreal, Quebec H3A 1T8

   7


Subsequent Events

On June 19, 2018, Theratechnologies closed a transaction of a note offering, or the Offering, which grossed US$57,500,000 including the full exercise of the over-allotment option.

The notes are direct, senior, unsecured obligations of Theratechnologies and bear interest at a rate of 5.75% per annum, payable semi-annually on June 30 and December 31 of each year, commencing on December 31, 2018.

Theratechnologies used the net proceeds of the Offering to fund payments totaling US$23,850,000 due under the third amendment to the EMD Serono termination and transfer agreement, or the Renegotiated Agreement. Theratechnologies also intends to use an amount of approximately US$5,000,000 for the approval and commercialization of Trogarzo in Europe and other jurisdictions, an amount of approximately US$5,000,000 to fund working capital and the remainder will be allocated for other general corporate purposes, including potential acquisitions in the execution of its business plan.

The Renegotiated Agreement signed with EMD Serono enabled Theratechnologies to realize savings from a reduction of future payment obligations and also to eliminate a royalty payment that was previously impacting the company’s gross profit margins. The transaction is expected to be accretive to the company’s EBITDA by over US$4.5 million per year for the next four or five years. Furthermore, as part of the Renegotiated Agreement, EMD Serono agreed to cancel all liens, hypothec and security interest over Theratechnologies’ assets.

Giving effect to the Notes offering and the Renegotiated Agreement, the pro forma cash position was $64,263,000 at May 31, 2018.

Recent Changes in Accounting Standards

Amendments Adopted

Amendments to IAS 7

On January 7, 2016, the IASB issued Disclosure Initiative (amendments to IAS 7). The amendments require disclosures that enable users of consolidated financial statements to evaluate changes in liabilities arising from financing activities, including both changes arising from cash flows and non-cash changes. One way to meet this new disclosure requirement is to provide reconciliation between the opening and closing balances for liabilities from financing activities. The required disclosures are provided in note 7 to our Interim Financial Statements.

Outstanding Securities Data On July 3, 2018, the number of common shares issued and outstanding was 76,658,013 while outstanding options granted under our stock option plans were 2,392,371. We also had US$57,500,000 aggregate principal amount of 5.75% convertible unsecured senior notes due June 30, 2023 issued and outstanding as a result of the Offering. These notes are convertible into common shares at the option of the holder at a conversion price of US$14.85, representing a conversion rate of approximately 67.3401 common shares per US$1,000 principal amount of notes. The conversion of all of the outstanding notes would result in the issuance of 3,872,053 common shares.

 

Theratechnologies Inc.

2015 Peel, 5th Floor

Montreal, Quebec H3A 1T8

   8


Contractual Obligations

There was no material change in contractual obligations during the three-month period ended May 31, 2018, other than in the ordinary course of business except on May 1, 2018 when Theratechnologies announced that it had been released from post-approval commitments by the FDA as it was determined that these two large-scale post-approval clinical trials were no longer required as the current labeling adequately reflects the safety profile of EGRIFTA®.

Economic and Industry Factors

Economic and industry factors were substantially unchanged from those reported in our MD&A for the fiscal year ended November 30, 2017.

Internal Control

No significant changes have occurred in our internal control over financial reporting during the period beginning on March 1, 2018 and ending on May 31, 2018.

Non-IFRS Financial Measures

Reconciliation of net profit or loss to adjusted earnings before interest, taxes, depreciation and amortization (Adjusted EBITDA)

Adjusted EBITDA is a non-IFRS financial measure. A reconciliation of the Adjusted EBITDA to net profit (loss) is presented in the table below. We use adjusted financial measures to assess our operating performance. Securities regulations require that companies caution readers that earnings and other measures adjusted to a basis other than IFRS do not have standardized meanings and are unlikely to be comparable to similar measures used by other companies. Accordingly, they should not be considered in isolation. We use Adjusted EBITDA to measure operating performance from one period to the next without the variation caused by certain adjustments that could potentially distort the analysis of trends in our business, and because we believe it provides meaningful information on our financial condition and operating results.

We obtain our Adjusted EBITDA measurement by adding to net profit or loss, finance income and costs, depreciation and amortization, and income taxes. We also exclude the effects of certain non-monetary transactions recorded, such as share-based compensation for the stock option plan and write-downs (or related reversals) of inventories, for our Adjusted EBITDA calculation. We believe it is useful to exclude these items as they are either non-cash expenses, items that cannot be influenced by management in the short term, or items that do not impact core operating performance. Excluding these items does not imply they are necessarily nonrecurring. Share-based compensation costs are a component of employee remuneration and can vary significantly with changes in the market price of the Company’s shares. In addition, other items that do not impact core operating performance of the Company may vary significantly from one period to another. As such, Adjusted EBITDA provides improved continuity with respect to the comparison of our operating results over a period of time.

 

Theratechnologies Inc.

2015 Peel, 5th Floor

Montreal, Quebec H3A 1T8

   9


Our method for calculating Adjusted EBITDA may differ from that used by other companies.

Adjusted EBITDA

(In thousands of Canadian dollars)

 

     Three-month periods
ended May 31,
     Six-month periods
ended May 31,
 
     2018      2017      2018      2017  

 

   $        $        $        $    

Net loss

     (2,460      (9,109      (5,087      (11,352

Add (deduct):

           

Depreciation and amortization

     538        516        1,018        1,020  

Finance costs

     368        4,625        563        6,897  

Finance income

     (100      (84      (200      (149

Share-based compensation for stock option plan

     438        485        633        617  

Write-down of inventories

     162        (172      (2      (47
  

 

 

    

 

 

    

 

 

    

 

 

 

Adjusted EBITDA

     (1,054      (3,739      (3,075      (3,014
  

 

 

    

 

 

    

 

 

    

 

 

 

Forward-Looking Information

This MD&A contains forward-looking statements and forward-looking information, or collectively, forward-looking statement, within the meaning of applicable securities laws, that are based on our management’s beliefs and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as “may”, “will”, “should”, “could, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect”, and “estimate, or the negative of these terms, or variations of them. The forward-looking statements contained in this MD&A include, but are not limited to, statements regarding the building of a portfolio of products, the growth of our revenue and cash flow, the filing of a marketing authorization seeking the approval of Trogarzo in Europe, and the addition of Trogarzo on reimbursement formularies of public and private payers in the United States.

 

Theratechnologies Inc.

2015 Peel, 5th Floor

Montreal, Quebec H3A 1T8

   10


Forward-looking statement are based upon a number of assumptions and include, but are not limited to, the following: sales of EGRIFTA® will continue to grow, we will succeed in building a portfolio of products generating increasing revenues and cash flow, the FDA will approve the sNDA and private and public payers in the United States will add Trogarzo on their reimbursement formularies.

Forward-looking statements are subject to a variety of risks and uncertainties, many of which are beyond our control that could cause our actual results to differ materially from those that are disclosed in or implied by the forward-looking statement contained in this MD&A. These risks and uncertainties include, among others, the risk that we may not find products that are compatible with our commercial platform, or that those products do not generate the anticipated revenues and cash flow, the risk that the FDA does not approve the sNDA, the risk that private and public payers in the United States do not include Trogarzo as a reimbursed drug, or, even if reimbursed, that they include conditions that we are unaware of that must be met prior to reimbursing Trogarzo.

We refer potential investors to the “Risk Factors” section of our annual information form dated February 6, 2018 for additional risks regarding the conduct of our business and Theratechnologies. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-looking statements reflect current expectations regarding future events and speak only as of the date of this MD&A and represent our expectations as of that date.

We undertake no obligation to update or revise the information contained in this MD&A, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.

 

Theratechnologies Inc.

2015 Peel, 5th Floor

Montreal, Quebec H3A 1T8

   11