EX-99.2
Exhibit 99.2
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
Overview
We are a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that
compromise a woman’s reproductive health and pregnancy. We are focused on providing therapeutic solutions for women between the ages of 15 and 49 who suffer from reproductive health conditions that affect their quality of life, ability to
conceive or that complicate pregnancy and the health of newborns. Our goal is to build the leading women’s reproductive health and pregnancy company focused on conditions where current treatment options are limited and significant unmet needs
exist.
We are developing OBE2109 as a novel, oral gonadotropin releasing hormone, or GnRH, receptor antagonist, for the treatment of pain associated with
endometriosis and heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women. We are currently conducting a multiple-dose, placebo-controlled Phase 2b clinical trial of OBE2109 in
approximately 330 patients with endometriosis, or the EDELWEISS clinical trial. Patient recruitment was completed in November, and we expect to report results from the first 12-week evaluation period of this
trial around mid-2018, with subsequent Phase 3 initiation planned by the end of 2018. For the uterine fibroids indication, in April 2017, we initiated a Phase 3 clinical development program with two Phase 3
clinical trials, or the PRIMROSE clinical trials. We expect to report data from the first 24-week evaluation period of these Phase 3 clinical trials in the second half of 2019 and 52-week data in the first half of 2020.
We are also developing nolasiban, an oral oxytocin receptor antagonist, to
improve clinical pregnancy and live birth rates in women undergoing in-vitro fertilization, or IVF. We completed randomization of 778 patients in our European Phase 3 clinical trial in women undergoing IVF, or
the IMPLANT2 clinical trial, in October 2017 and expect to report data for the primary endpoint in the first quarter of 2018.
In addition, we are
developing OBE022, an oral and selective prostaglandin F2α receptor antagonist, for preterm labor in weeks 24 to 34 of
pregnancy. Based on results of Phase 1 clinical trials completed in February and March 2017, we are advancing OBE022 into Phase 2a Proof-of-Concept clinical trial, or
the PROLONG clinical trial, in the fourth quarter of 2017 to assess its safety and efficacy to delay birth in women 24 to 34 weeks pregnant who face preterm labor and potentially preterm delivery. We expect initial PK/safety results from Part A of
this trial in the second quarter of 2018 and preliminary efficacy from Part B in late 2018.
We were founded in November 2012 and our operations to date
have included organizing and staffing our company, raising capital, in-licensing rights to OBE2109, nolasiban and OBE022 and conducting nonclinical studies and clinical trials. To date, we have not generated
any revenue from product sales as none of our product candidates have been approved for commercialization. We have historically financed our operations exclusively through the sale of equity. As of September 30, 2017, we have raised an
aggregate of $181.8 million of net proceeds, including the proceeds from our initial public offering, and also acquired license rights on product candidates from the sale of equity securities. Additionally, in October 2017 we raised
approximately $ 56.3 million of net proceeds, in a private placement with institutional investors.
We have never been profitable and have incurred
significant net losses in each period since our inception. Our net losses were $17.0 million and $7.9 million for the three-month periods ended September 30, 2017, and 2016, respectively, and $49.9 million and $19.1 million
for the nine-month periods ended September 30, 2017, and 2016, respectively. As of September 30, 2017, we had accumulated losses of $120.1 million, out of which $30.6 million were offset with share premium. This reclassification
transaction had no impact on total equity. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate that our expenses will increase significantly in connection with our ongoing activities as
we:
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continue to invest in the clinical development of our product candidates and specifically in connection with our ongoing EDELWEISS, PRIMROSE, IMPLANT2 clinical trials and our planned PROLONG clinical trial, and any
additional clinical trials and nonclinical studies that we may conduct for product candidates; |
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hire additional research and development, and general and administrative personnel; |
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maintain, expand and protect our intellectual property portfolio; |
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identify and in-license or acquire additional product candidates; and |
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continue to incur additional costs associated with operating as a public company. |
We will need substantial
additional funding to support our operating activities as we advance our product candidates through clinical development, seek regulatory approval and prepare for, and if any of our product candidates are approved, proceed to commercialization.
Adequate funding may not be available to us on acceptable terms, or at all.
We have no manufacturing facilities, and all of our manufacturing activities
are contracted out to third parties. Additionally, we currently utilize third-party Contract Research Organizations, or CROs, to carry out our clinical development and trials. We do not yet have a commercialization organization.
Strategic Licensing Agreements
OBE2109
In November 2015, we entered into the Kissei license and supply agreement with Kissei Pharmaceutical Co., Ltd., or Kissei. Pursuant to the Kissei
license and supply agreement we received an exclusive license to develop, manufacture and commercialize products, or the Product, containing the compounds which is a specified GnRH antagonist and covered by certain licensed patent rights, or the
Compound, throughout the world except for specified Asian countries and we arranged to exclusively acquire from Kissei the material necessary to produce OBE2109.
In consideration for the license, we made an initial $10.0 million upfront payment. In addition, we agreed to make aggregate milestone payments of up to
$63.0 million upon the achievement of specified developmental milestones, such as the initiation of clinical trials and receipt of regulatory approvals. In connection with the initiation of the Phase 3 clinical program for OBE2109 in uterine
fibroids in the second quarter of 2017, a $5.0 million milestone was paid. With respect to any products we commercialize under the Kissei license and supply agreement, we agreed to make further payments of up to an additional
$125.0 million to Kissei upon the achievement of specified commercial milestones.
Pursuant to the Kissei license and supply agreement, we have
agreed to exclusively purchase the active pharmaceutical ingredient for OBE2109 from Kissei. During the development stage, we are obligated to pay Kissei a specified supply price. Following the first commercial sale of licensed product, we are
obligated to pay Kissei a royalty payment in the low twenty percent range as a percentage of net sales, which includes payment for Kissei’s supply of the active pharmaceutical ingredient until the latest of the date that the valid claim of a
patent for the Product has expired, the expiration of our regulatory exclusivity period or 15 years from the first commercial sale of such product on a
country-by-country and product-by-product basis. During the term, we are restricted from
developing, marketing and selling GnRH agonists and GnRH antagonists other than the Compound to the extent allowed by applicable laws.
Nolasiban
In August 2013, we entered into the 2013 license agreement with Ares Trading S.A., an affiliate of Merck Serono, or Merck Serono, pursuant to
which we received a worldwide exclusive license to develop, manufacture and commercialize compounds covered by the licensed patent rights, including nolasiban. In consideration for the license, we issued 914,069 Series A preferred shares to Merck
Serono at the time of our Series A financing, which had a fair-value of $4.9 million based on an exchange rate of $1.00 for CHF 0.9244 as of the date of the transaction. With respect to any products we commercialize under the 2013 license
agreement, we agreed to pay Merck Serono royalties based on a high-single-digit percentage of annual net sales of each product, subject to specified reductions, until the later of the date that all of the patent rights for that product have expired,
as determined on a country-by-country and product-by-product basis, or ten years from the
first commercial sale of such product on a country-by-country and product-by-product
basis.
2
OBE022
In June 2015, we entered into the 2015 license agreement with Merck Serono, which we amended in July 2016, pursuant to which we received a worldwide exclusive
license to develop, manufacture and commercialize compounds covered by the licensed patent rights, including OBE022. In consideration for the license, we issued 325,000 Series A preferred shares to Merck Serono in September 2016 upon the initiation
of a Phase 1 clinical trial for a licensed product. With respect to any products we commercialize under the 2015 license agreement, we agreed to pay Merck Serono royalties based on a mid-single-digit
percentage of annual net sales of each product, subject to specified reductions, until the later of the date that all of the patent rights for that product have expired, as determined on a country-by-country and product-by-product basis or ten years from the first commercial sale of such product on a country-by-country and product-by-product basis.
Components of Results of Operations
Revenue
To date, we have not generated any revenue from product sales and do not expect to generate any revenue from product sales for the foreseeable
future.
Operating Expenses
Research and
Development Expenses
Research and development expenses consist primarily of costs incurred in connection with our research and development activities
and consist mainly of direct research costs, which include: costs associated with the use of CROs and consultants hired to assist on our research and development activities; personnel expenses, which include salaries, benefits and share-based
compensation expenses for our employees; expenses related to regulatory affairs and intellectual property; manufacturing costs in connection with conducting nonclinical studies and clinical trials; and depreciation expense for assets used in
research and development activities. Research and development costs are generally expensed as incurred. However, costs for certain activities, such as manufacturing and nonclinical studies and clinical trials, are generally recognized based on an
evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and collaborators.
We typically use
our employee, consultant and infrastructure resources across our development programs. We track outsourced research and development costs by product candidate or nonclinical program, but we do not allocate personnel costs, other internal costs or
external consultant costs to specific product candidates.
From inception through September 30, 2017, we have incurred $95.8 million in research
and development expenses to advance the development of our product candidates.
The following table provides a breakdown of our outsourced research and
development expenses that are directly attributable to the specified product candidates for the three-month and nine-month periods ended September 30, 2017 and 2016.
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Three-month period ended
September 30, |
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Nine-month period ended
September 30, |
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2017 |
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2016 |
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2017 |
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|
2016 |
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|
(in thousands) |
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(unaudited) |
|
| OBE2109 |
|
$ |
(7,644 |
) |
|
$ |
(2,604 |
) |
|
$ |
(24,171 |
) |
|
$ |
(5,538 |
) |
| Nolasiban |
|
|
(2,743 |
) |
|
|
(543 |
) |
|
|
(6,519 |
) |
|
|
(3,029 |
) |
| OBE022 |
|
|
(514 |
) |
|
|
(1,336 |
) |
|
|
(1,706 |
) |
|
|
(2,687 |
) |
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|
|
|
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| Total outsourced research and development expenses |
|
$ |
(10,901 |
) |
|
$ |
(4,483 |
) |
|
$ |
(32,396 |
) |
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$ |
(11,254 |
) |
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3
We expect our research and development expense will increase for the foreseeable future as we seek to advance the
development of our product candidates. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of our product candidates. We are also unable to
predict when, if ever, material net cash inflows will commence from sales of our product candidates. This is due to the numerous risks and uncertainties associated with developing such product candidates, including:
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the number of clinical sites included in the trials; |
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the length of time required to enroll suitable patients; |
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the number of patients that ultimately participate in the trials; |
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the number of doses patients receive; |
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the duration of patient follow-up; and |
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the results of our clinical trials. |
In addition, the probability of success for any of our product candidates
will depend on numerous factors, including competition, manufacturing capability and commercial viability. A change in the outcome of any of these variables with respect to the development of any of our product candidates would significantly change
the costs, timing and viability associated with the development of that product candidate.
General and Administrative Expenses
General and administrative expenses consist primarily of personnel expenses, including salaries, benefits and share-based compensation expense, for personnel
in executive, finance, accounting, business development, legal and human resource functions. General and administrative expense also includes corporate facility costs not otherwise included in research and development expenses, legal fees related to
corporate matters and fees for accounting and consulting services.
We anticipate that our general and administrative expense will increase in the future
to support continued research and development activities. We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance and director and officer insurance costs, as well as investor and public relations expenses,
associated with operating as a public company.
Finance Result, Net
Finance result, net, consists mainly of interest income and expense on our cash and cash equivalents and foreign exchange gains and losses.
Taxation
We are subject to corporate taxation in
Switzerland, Ireland and the United States. Since we have only incurred net losses since our inception and our Irish subsidiary has no activity, our U.S. subsidiary was the only entity to generate income tax expenses as of September 30, 2017.
In 2015, the Canton of Geneva granted us a ten year tax holiday for all income and capital taxes on a communal and cantonal level commencing in fiscal
year 2013 and valid through to 2022, subject to our Swiss domiciliation and compliance with certain reporting provisions.
We are also entitled under
Swiss laws to carry forward any losses incurred for a period of seven years and can offset our losses carried forward against future taxes. As of December 31, 2016, we had tax loss carryforwards totaling $57.0 million. We do not believe it
is probable that we will generate sufficient profits to avail ourselves of these tax loss carryforwards.
4
Analysis of Results of Operations
Comparison of the three-month periods ended September 30, 2017 and 2016
Operating Expenses
Research and Development
Expenses
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Three-month period ended
September 30, |
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2017 |
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2016 |
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(in thousands) |
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(unaudited) |
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| Research and development expenses by product candidate |
|
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| OBE2109 |
|
$ |
(7,644 |
) |
|
$ |
(2,604 |
) |
| Nolasiban |
|
|
(2,743 |
) |
|
|
(543 |
) |
| OBE022 |
|
|
(514 |
) |
|
|
(1,336 |
) |
| Unallocated expenses |
|
|
|
|
|
|
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| Staff costs |
|
|
(2,573 |
) |
|
|
(1,083 |
) |
| Other research and development costs |
|
|
(436 |
) |
|
|
(412 |
) |
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| Total research and development expenses |
|
$ |
(13,910 |
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|
$ |
(5,978 |
) |
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Research and development expenses increased by $7.9 million in the three-month period ended September 30, 2017
compared to the three-month period ended September 30, 2016 primarily due to the increased costs of $5.0 million resulting from our ongoing PRIMROSE and EDELWEISS clinical trials with OBE2109, the increased costs of $2.2 million
resulting from our ongoing IMPLANT2 clinical trial with nolasiban and increased staff costs of $1.5 million associated with increased headcount and share-based compensation.
General and Administrative Expenses
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Three-month period ended
September 30, |
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2017 |
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2016 |
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(in thousands) |
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(unaudited) |
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| Staff costs |
|
$ |
(1,983 |
) |
|
$ |
(348 |
) |
| Professional fees |
|
|
(554 |
) |
|
|
(1,458 |
) |
| Other general and administrative costs |
|
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(464 |
) |
|
|
(140 |
) |
|
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| Total general and administrative expenses |
|
$ |
(3,001 |
) |
|
$ |
(1,946 |
) |
|
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|
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General and administrative expenses increased by $1.1 million in the three-month period ended September 30, 2017
compared to the three-month period ended September 30, 2016 primarily due to increased staff costs of $1.6 million associated with increased headcount and share-based compensation, which were partially offset by decreased professional fees
of $0.9 million, mainly related to costs of preparation of our initial public offering in the three-month period ended September 30, 2016.
Finance Result, Net
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Three-month period ended
September 30, |
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2017 |
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2016 |
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(in thousands)
(unaudited) |
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| Finance result, net |
|
$ |
(107 |
) |
|
$ |
(29 |
) |
5
Finance losses in the three-month periods ended September 30, 2017 and 2016 primarily consisted of foreign
exchange gains and losses.
Comparison of the nine-month periods ended September 30, 2017 and 2016
Operating Expenses
Research and Development
Expenses
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Nine-month period ended
September 30, |
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2017 |
|
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2016 |
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(in thousands) |
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(unaudited) |
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| Research and development expenses by product candidate |
|
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| OBE2109 |
|
$ |
(24,171 |
) |
|
$ |
(5,538 |
) |
| Nolasiban |
|
|
(6,519 |
) |
|
|
(3,029 |
) |
| OBE022 |
|
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(1,706 |
) |
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(2,687 |
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| Unallocated expenses |
|
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| Staff costs |
|
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(7,189 |
) |
|
|
(3,234 |
) |
| Other research and development costs |
|
|
(1,398 |
) |
|
|
(1,056 |
) |
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| Total research and development expenses |
|
$ |
(40,983 |
) |
|
$ |
(15,544 |
) |
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Research and development expenses increased by $25.4 million in the nine-month period ended September 30, 2017
compared to the nine-month period ended September 30, 2016 primarily due to the increased costs of $18.6 million resulting from our ongoing PRIMROSE and EDELWEISS clinical trials with OBE2109, the increased costs of $3.5 million
resulting from our ongoing IMPLANT2 clinical trial with nolasiban and increased staff costs of $4.0 million associated with increased headcount and share-based compensation.
General and Administrative Expenses
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Nine-month period ended
September 30, |
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|
2017 |
|
|
2016 |
|
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(in thousands) |
|
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|
(unaudited) |
|
| Staff costs |
|
$ |
(5,937 |
) |
|
$ |
(1,140 |
) |
| Professional fees |
|
|
(2,317 |
) |
|
|
(1,768 |
) |
| Other general and administrative costs |
|
|
(1,347 |
) |
|
|
(413 |
) |
|
|
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|
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|
|
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| Total general and administrative expenses |
|
$ |
(9,601 |
) |
|
$ |
(3,321 |
) |
|
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|
|
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|
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General and administrative expenses increased by $6.3 million in the nine-month period ended September 30, 2017
compared to the nine-month period ended September 30, 2016 primarily due to increased staff costs of $4.8 million associated with increased headcount and share-based compensation, and an increase of $0.9 million in other general and
administrative costs mainly associated with operating as a public company.
Finance Result, Net
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Nine-month period ended
September 30, |
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2017 |
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2016 |
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(in thousands)
(unaudited) |
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| Finance result, net |
|
$ |
753 |
|
|
$ |
(233 |
) |
Finance profit in the nine-month period ended September 30, 2017 and finance loss in the nine-month period ended
September 30, 2016 primarily consisted of foreign exchange gains and losses.
6
Liquidity and Capital Resources
Since our inception, we have not generated any revenue and have incurred net losses and negative cash flows from our operations. We have funded our operations
primarily through the sale of equity. From inception through September 30, 2017, we have raised an aggregate of $181.8 million of net proceeds from the sale of equity securities. In January 2017, we completed our initial public offering of
6,450,000 common shares at a public offering price of $15.00 per share. We received $88.6 million in net proceeds after deducting $8.2 million of underwriting discounts and commissions and other offering expenses. Additionally, in October
2017, we raised $60.0 million of gross proceeds through the issuance of 7,500,000 shares at a price of $8.00 per share in a private placement with institutional investors.
As of September 30, 2017, we had $68.4 million in cash and cash equivalents.
Our primary uses of cash are to fund operating expenses, primarily research and development expenditures. Cash used to fund operating expenses is impacted by
the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses. We currently have no ongoing material financing commitments, such as lines of credit or guarantees.
We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of, continue or
initiate clinical trials of, and seek marketing approval for, our product candidates. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to program sales,
marketing, manufacturing and distribution to the extent that such sales, marketing and distribution are not the responsibility of potential collaborators. Furthermore, we expect to continue to incur additional costs associated with operating as a
public company. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate
our research and development programs or future commercialization efforts.
We expect our existing cash and cash equivalents, including the net proceeds
from the October 2017 offering, will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2019. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our
available capital resources sooner than we currently expect. Our future capital requirements will depend on many factors, including:
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the scope, progress, results and costs of our ongoing and planned nonclinical studies and clinical trials for OBE2109, nolasiban and OBE022; |
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the cost and timing of ongoing and planned manufacturing activities including active pharmaceutical ingredient and drug product pharmaceutical development and clinical trial supplies production for OBE2109, nolasiban
and OBE022; |
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the timing and amount of milestone and royalty payments we are required to make under our license agreements; |
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the extent to which we in-license or acquire other product candidates and technologies; |
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the number and development requirements of other product candidates that we may pursue; |
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the costs, timing and outcome of regulatory review of our product candidates; |
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the costs and timing of future commercialization activities, including drug manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval; |
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the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; |
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our ability to establish strategic collaborations; and |
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the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims. |
Identifying potential product candidates and conducting nonclinical studies and clinical trials is a time-consuming, expensive and uncertain process that
takes many years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our product candidates, if approved, may not achieve commercial success. Our revenue,
if any, will be derived from sales of products that we do not expect to be commercially available for many years, if at all.
Until such time, if ever, as
we can generate substantial product revenue, we may finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements.
To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the
terms of any additional securities may include liquidation or other preferences that adversely affect your rights as a shareholder. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to
take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
If we raise funds through additional
collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may
not be favorable to us.
If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit,
reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
The following table shows a summary of our cash flows for the nine-month periods ended September 30, 2017 and 2016:
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Nine-month period ended
September 30, |
|
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|
2017 |
|
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2016 |
|
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(in thousands) |
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(unaudited) |
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| Cash and cash equivalents at beginning of period |
|
$ |
25,508 |
|
|
$ |
54,275 |
|
| Net cash used in operating activities |
|
|
(41,539 |
) |
|
|
(16,589 |
) |
| Net cash used in investing activities |
|
|
(5,244 |
) |
|
|
(38 |
) |
| Net cash from financing activities |
|
|
88,879 |
|
|
|
19 |
|
| Effect of exchange rates |
|
|
754 |
|
|
|
1,243 |
|
|
|
|
|
|
|
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| Cash and cash equivalents at end of period |
|
$ |
68,358 |
|
|
$ |
38,910 |
|
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|
|
|
|
|
|
|
|
Operating Activities
Net
cash used in operating activities consists of net loss before tax adjusted for changes in net working capital, that is current assets less current liabilities, and for non-cash items such as depreciation and
amortization and the value of share-based services.
During the nine-month period ended September 30, 2017, operating activities used
$41.5 million of cash, primarily as the result of our net loss before tax of $49.8 million, as adjusted for non-cash items and changes in the net working capital.
Non-cash items amounted to $6.1 million and mainly consisted of share-based payments. Changes in the net working capital included primarily a $1.3 million increase in accrued expenses, mainly due to
the costs of our clinical trial supplies for our PRIMROSE and EDELWEISS clinical trials.
During the nine-month period ended September 30, 2016,
operating activities used $16.6 million of cash, primarily as the result of our net loss before tax of $19.1 million, as adjusted for non-cash items and changes in the net working capital. Non-cash items amounted to $0.7 million and mainly consisted of share-based payments. Changes in the net working capital included primarily a $2.1 million increase in accrued expenses, mainly due to our
ongoing Phase 2b clinical trial of OBE2109 in endometriosis during the period.
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Investing Activities
During the nine-month period ended September 30, 2017, net cash used in investing activities consisted primarily of a $5.0 million milestone payment
to Kissei made upon initiation of the Phase 3 clinical program for OBE2109 in uterine fibroids.
During the nine-month period ended September 30,
2016, net cash used in investing activities consisted primarily of investments in furniture and fixtures.
Financing Activities
During the nine-month period ended September 30, 2017, net cash from financing activities consisted primarily of proceeds from the sale of equity
securities in our IPO.
Main Contractual Obligations and Commitments
Under our license agreements with Kissei and Merck Serono, we may be required to pay royalties in the future. In addition, pursuant to the Kissei license and
supply agreement, we have agreed to make aggregate milestone payments of up to $63.0 million upon the achievement of specified developmental milestones, such as the initiation of clinical trials and receipt of regulatory approvals, out of which
$5.0 million were already paid as of September 30, 2017. With respect to any product we commercialize under the Kissei license and supply agreement, we have agreed to make additional aggregate milestone payments of up to
$125.0 million to Kissei upon the achievement of specified commercial milestones.
We enter into contracts in the normal course of business with CROs
for clinical trials, nonclinical studies, manufacturing and other services and products for operating purposes. These contracts generally provide for termination upon notice, and therefore we believe that our
non-cancelable obligations under these agreements are not material.
Off-Balance Sheet Arrangements
As of the date of this discussion and analysis, we do not have any, and during the periods presented we did not have any,
off-balance sheet arrangements.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated interim financial statements,
which we have prepared in accordance with International Accounting Standard 34 Interim Financial Reporting as issued by the International Accounting Standards Board.
The accounting policies used in the preparation and presentation of these consolidated interim financial statements are consistent with those used in the
consolidated financial statements for the year ended December 31, 2016, which should be read in conjunction with these consolidated interim financial statements and management’s discussion and analysis as they provide an update of
previously reported information.
The preparation of our consolidated interim financial statements requires us to make estimates and assumptions that
affect the reported amounts of revenues, expenses, assets, liabilities and disclosure of contingent liabilities at the date of the interim financial statements. We base our estimates and assumptions on historical experience and other factors that we
believe to be reasonable under the circumstances. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates.
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Recent Accounting Pronouncements
There are no IFRS standards as issued by the IASB or interpretations issued by the IFRS interpretations committee that are effective for the first time for the
financial year beginning on or after January 1, 2017 that would be expected to have a material impact on our financial position.
Controls and
procedures
As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in such
internal control. Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, requires that we evaluate and determine the effectiveness of our internal control over financial reporting and, beginning with our annual report on Form
20-F for our year ending December 31, 2017, provide a management report on internal control over financial reporting. The process of designing and implementing internal control over financial reporting
required to comply with Section 404 of the Sarbanes-Oxley Act will be time consuming, costly and complicated. If during the evaluation and testing process, we identify material weaknesses in our internal control over financial reporting, our
management will be unable to assert that our internal control over financial reporting is effective. If we are unable to assert that our internal control over financial reporting is effective, we will need to undertake various actions, such as
implementing new internal controls and procedures and hiring additional staff to remediate the material weaknesses.
JOBS Act Exemption
In April 2012, the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, was enacted. Section 107 of the JOBS Act provides that an “emerging
growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended for complying with new or revised accounting standards. Thus, an emerging growth company can
delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this extended transition period and, as a result, we will adopt new or revised
accounting standards on the relevant dates on which adoption of such standards is required for other public companies.
As an emerging growth company,
subject to certain conditions, we are relying on certain of exemptions under the JOBS Act, including without limitation, (1) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to
Section 404(b) of the Sarbanes-Oxley Act and (2) complying with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report
providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an emerging growth company until the earlier to occur of (1) the last day of the fiscal year
(a) following the fifth anniversary of the completion of this offering, (b) in which we have total annual gross revenues of at least $1.07 billion or (c) in which we are deemed to be a “large accelerated filer” under
the rules of the U.S. Securities and Exchange Commission, which means the market value of our common shares that is held by non-affiliates exceeds $700 million as of the prior June 30, and
(2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.
Cautionary Statement Regarding Forward-Looking Statements
Forward-looking statements appear in a number of places in this discussion and analysis and include, but are not limited to, statements regarding our intent,
belief or current expectations. Many of the forward-looking statements contained in this discussion and analysis can be identified by the use of forward-looking words such as “anticipate”, “believe”, “continue”,
“could”, “estimate”, “expect”, “intend”, “may”, “might”, “ongoing”, “objective”, “plan”, “potential”, “predict”, “should”,
“will” and “would”, or the negative of these and similar expressions. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements
are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those identified under the section entitled
“Item 3.D—Risk Factors” in the Annual Report on Form 20-F for the year ended December 31, 2016, or the Annual Report, filed with the U.S. Securities and Exchange Commission, or the
SEC, pursuant to the U.S. Securities and Exchange Act of 1934, as amended. These risks and uncertainties include factors relating to:
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the success, cost, timing and potential indications of our product candidates’ development activities and clinical trials, including our ongoing and future trials of OBE2109, nolasiban and OBE022;
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our ability to obtain and maintain regulatory approval of our product candidates, including OBE2109, nolasiban and OBE022, in any of the indications for which we plan to develop them, and any related restrictions,
limitations or warnings in the label of an approved product; |
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the results of ongoing or future clinical trials, including of OBE2109, nolasiban and OBE022; |
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our ability to obtain funding for our operations, including funding necessary to complete the clinical trials of any of our product candidates, and the terms on which we are able to raise that additional capital;
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our plans to research, develop and commercialize our product candidates; |
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the timing of our regulatory filings for our product candidates; |
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the clinical utility of our product candidates; |
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the size and growth potential of the markets for our product candidates; |
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our commercialization, marketing and manufacturing capabilities and strategy; |
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our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates and our ability to operate our business without infringing on the intellectual property rights of
others; |
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the timing and amount of milestone and royalty payments we are required to make under our license agreements; |
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our ability to attract and retain qualified employees and key personnel; |
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our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; |
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the activities of our competitors and the success of competing therapies that are or become available; |
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our plans to in-license or acquire additional product candidates; |
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how long we will qualify as an emerging growth company or a foreign private issuer; |
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our estimates regarding future revenue, expenses and needs for additional financing; |
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regulatory developments in the United States and foreign countries; and |
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other risks and uncertainties, including those listed in the Annual Report, titled “Item 3.D—Risk Factors.” |
Forward-looking statements speak only as of the date they are made, and we do not undertake any obligation to update them in light of new information or
future developments or to release publicly any revisions to these statements in order to reflect later events or circumstances or to reflect the occurrence of unanticipated events.
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