Mithra Reports 2018 Annual Results

Liege, Belgium, 01 March 2019– 7 :30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces its results for the year ended 31 December 2018, prepared in accordance with IFRS.

Financial highlights

• Revenues increased by over 42% to EUR 65.5 million (from EUR 46.3 million in 2017), mainly due to licensing revenues recognized for partnership agreements with leaders in Women’s Health such as Gedeon Richter for EUR 40 million.
• EBITDA[1] significantly improved to EUR 38.3 million in 2018 compared to EUR -18.4 million in 2017 – increase by 308 %.
• The company raised EUR 77.5 million in gross proceeds in May 2018 with a capital increase by means of a private placement of 2,672,414 new shares to fund clinical development of its key assets.
• Increase of EUR 18.5 million of non-recurring income in 2018 due to the gain on sale of disposal of Ceres Pharma realized in July 2018.
• Cash at December 31 2018 was EUR 119 million (EUR 36.2 million in 2017); with the cash generated from operating and investment activities strengthened by the private placement in May 2018.
• R&D spend decreases to EUR 35.7 million (from EUR 48.2 million in 2017), reflecting the completion of the Phase III Estelle® and Phase II Donesta® programs.

Key Highlights (including post-period end)

• Positive top-line results of Estelle® Phase III oral contraceptive study ("E4 Freedom") in both Europe/Russia and the United States/Canada. These results confirm the unique safety profile of Mithra's innovative contraceptive, as well as the previous data from the Estelle® Phase II study on hemostasis and ovarian function. Mithra intends to file with European and American regulatory agencies by the end of 2019.
• Positive top-line results of the Donesta® Phase II study ("E4 Relief") for the treatment of vasomotor symptoms, in particular hot flushesrelief, in postmenopausal women. Phase III studies are expected to launch in the second half of 2019, pending approvals.
• Expansion of the E4 development program with a third late stage clinical product candidate, PeriNesta™, for the underserved perimenopausal market. PeriNesta™ has the potential to offer women an improved benefit/risk contraceptive solution while addressing the challenge of hot flushes.
• Commercialization agreements signed for Estelle® in key international markets including Europe and Russia (Gedeon Richter), Canada (Searchlight Pharma), South Africa (Adcock Ingram), South Korea (Hyundai Pharm) and, post-period end MENA region[2] (ITROM).
• Commercialization agreements for Myring™ signed with Alvogen (Russia), Orifarm (Denmark), Laboratorio Pasteur (Chile), Neo Health (Australia/New Zealand) and ITROM (MENA region).
• First marketing authorization (MA) received for Myring™ in Europe (United Kingdom), followed by MAs in seven other Eastern European countries (Hungary, Latvia, Croatia, the Czech Republic, Poland, Slovakia and Slovenia).
• Abbreviated New Drug Application (ANDA) accepted for filling by the FDA for the U.S. commercialization of Myring™. The production of test batches for the additional bioequivalence data requested by the FDA in a Complete Response Letter (CRL) received by Mithra’s U.S partner Mayne Pharma will be finalized in the first half of 2019.
• Launch of the manufacturing process of Myring™ at Mithra CDMO[3] facility in Belgium, with the production of first commercial batches for the European market.
• Investment in new state-of-the-art equipment allowing Mithra CDMO to triple its production capacity to meet the expected international market demands.
• Strategic divestment of Belgian and Luxembourg activities to Ceres Pharma worth up to EUR 40 million.

François Fornieri, CEO Mithra Women’s Health, commented: “2018 was a very successful year from all points of view. Revenue growth in 2018 was significantly boosted by down payments and milestones from our strategic partnerships and divestment of non-strategic activities, increasing 42% to EUR 65.5 million in 2018 from 46.3 million in 2017. EBITDA also improved significantly to EUR 38.3 million, as did our cash position, which reached a record level of EUR 119 million. In 2019 and beyond, we expect further significant revenue growth based on the potential for further E4 partnerships in the U.S. and other international markets.

Our key clinical programs have successfully completed significant milestones, bringing our three potential blockbusters closer to the market. The positive top-line results of the Estelle® Phase III study in both Europe/Russia and the U.S./Canada confirmed the novel efficacy and safety profile and great potential of Estelle®, a true 5^th generation oral contraceptive, which will offer women a unique innovative therapeutic solution. We intend to file for approval with regulatory agencies by the end of 2019 and will continue negotiations for commercial partners for Estelle® in the United States as well as in other leading markets.

We are also continuing to progress our novel candidate for menopausal symptoms, Donesta®. The results of the Phase II study of Donesta® for the treatment of vasomotor symptoms in postmenopausal women confirmed its unique potential with an improved benefit/risk profile. Following these positive results, we are accelerating Phase III study plans and intend to start in the second half of 2019, pending approvals.

Mithra has also entered a major new and untapped commercial market, perimenopause. Our third potential blockbuster, PeriNesta™, has the potential to become the first product on the market for perimenopausal women, offering an improved benefit/risk contraceptive solution while addressing the first menopausal symptoms. Pending approvals, Mithra is targeting a marketing authorization for both Donesta® and PeriNesta™ product candidates in 2023. With our three innovative products, Mithra has the potential to provide the right therapeutic option for women at each stage of their entire hormonal cycle.

Our successful partnering strategy continued to develop in 2018, with major commercial contracts including Gedeon Richter for Estelle® in Europe and Russia and Alvogen for Myring™ in Russia. The continuing expansion of our international partnerships demonstrates Mithra’s growing reputation as a leading innovator in Women’s Health.

In order to meet the expected international market demands, our Mithra CDMO will strengthen its activities in both the R&D and production. Thanks to its new state-of-the-art equipment and proven expertise, we have tripled our production capacity to deliver the next commercial batches of the vaginal ring Myring™ in the second half of 2019.”

OPERATIONAL OVERVIEW

1. Estetrol (E4) Program

Estelle^® - The combined oral contraceptive (COC) product candidate, composed of 15 mg Estetrol (E4) and 3 mg Drospirenone (DRSP) – Phase III study (« E4 Freedom »)

Positive top-line results for the Phase III studies in Europe/Russia and U.S./Canada were announced in August 2018 and, post-period end, in January 2019, respectively. A total of 3,725 women were included in the studies and these positive results confirm the outstanding safety profile of Estelle® as a novel, next-generation combined oral contraceptive.

• In March 2018, Mithra announced positive results from its Phase II hemostasis study of Estelle® at the International Society of Gynecological Endocrinology Conference (ISGE) in Florence. The aim of the study was to determine the risk profile of Estelle® for deep venous thrombosis (DVT) and pulmonary embolism. As required by the regulatory agencies, LNG (levonogestrel) was included as a comparator. Mithra elected to include Yaz® (DRSP COC, benchmark for Estelle®) as an additional comparative arm, given the well-documented elevated DVT risk for current DRSP-based COCs relative to LNG-based products. These results corroborate earlier findings, delineate the unique safety profile and contribute to the potential of Estelle® as a ‘fifth generation pill’, combining the quality of life offered by DRSP with a safer hemostatic profile compared to other DRSP COC’s. Based on these positive data, Mithra applied for an additional patent relating to the E4 synthesis process and E4 as a potential new emergency option to further strengthen and extend the existing Estelle® and E4 intellectual property estate.
• In April 2018, Mithra announced it had signed a binding Heads of Terms agreement with Searchlight Pharma, for an exclusive license to commercialize Estelle® in Canada. Under the terms of the agreement, Mithra is eligible to receive up to EUR 15 million in upfront payments and sales-related income. Mithra will also manufacture Estelle® for Searchlight at its CDMO facility and will receive guaranteed annual recurring revenues based on Minimum Annual Quantities (MAQ). Mithra forecasts the agreement could achieve sales-related revenues of at least EUR 50 million for Mithra, based on market assumptions. The license and supply agreement was finalized with Searchlight Pharma in May 2018.
• In June 2018, Mithra announced it had signed a binding Heads of Terms agreement with Hyundai Pharm, for an exclusive license to commercialize Estelle® in South Korea. Under the terms of the agreement, finalized in September, Mithra is eligible to receive milestone payments, MAQ and further sales-related royalties. Mithra will also produce Estelle® for the South Korean market at its CDMO facility for the South Korean contraceptive market, which is worth approximately EUR 36 million a year, with Combined Oral Contraceptives (COCs)^[4] accounting for EUR 27 million.
• In August 2018, Mithra announced positive top-line results for the Phase III Estelle® study in Europe and Russia. The study successfully met its primary endpoint and achieved key secondary endpoints including outstanding bleeding profile, cycle control, quality of life and safety and tolerability. The primary endpoint was contraceptive efficacy measured by the number of pregnancies per 100 women per 12 months of exposure (Pearl Index; PI). The PI indicates a 99.5% efficacy rate over one year of use, exceeding the efficacy goals of the study.
• In September 2018, Mithra signed an exclusive license and supply agreement with Gedeon Richter to commercialize Estelle® in Europe/Russia, a key market that is valued at more than a fifth of the global oral contraception market (EUR 5.2 billion) ^[5]. Upon signature of the contract, Richter made an upfront payment of EUR 35 million. Additional milestone payments amounting to EUR 20 million will be made depending on the progress of the regulatory process of the product. Further sales-related milestones and royalties will be payable to Mithra subsequent to the launch of the product. Moreover, Mithra will receive guaranteed annual recurring revenues based on MAQ in addition to tiered royalties on net sales.
• In October 2018, Mithra announced an exclusive licence and supply agreement with Adcock Ingram for the commercialization of Estelle® in South Africa. Mithra is eligible to receive a downpayment of EUR 1.5 million. Mithra will also be eligible to receive additional commercialization milestone payments, further sales-related royalties, guaranteed annual recurring revenues based on MAQ, single digit tiered royalties on net sales and additional high double digit royalties on sales exceeding forecasts. Moreover, Mithra will produce Estelle® for Southern Africa at its CDMO facility in Belgium.
• Post-period end, in January 2019, Mithra announced positive topline results of Estelle® Phase III study in U.S./Canada. Primary efficacy endpoint indicates excellent contraceptive efficacy, with a Pearl Index (PI) of 2.41[6] per 100 women (98% efficacy rate), in line with expectations and similar to a recently FDA approved combined hormonal contraceptive (Annovera™^[7]) and one of the best-selling Combined Oral Contraceptives (COC) in the U.S. (Lo-loestrin®^[8]) with USD 527.7 million sales (15% yoy growth^[9]). Key secondary endpoints (same as the one for the EU/RU study) were also achieved.
• Post-period end, Mithra signed a partnership agreement with ITROM for commercialization of Estelle^® in the Middle East. Under the terms of the agreement, ITROM will distribute Estelle® in MENA territories where the COC market is estimated at EUR 30 million a year[10]. This agreement represents a deal worth up to EUR 55 million over the period.

Donesta® – next-generation hormone therapy (HT) product candidate with oral administration of Estetrol – Menopause – Phase II study (« E4 Relief »)

The results of the Phase II study of Donesta® for the treatment of vasomotor symptoms (VMS) in postmenopausal women confirmed the potential of Donesta® as a new generation hormonal therapy with a better benefit/risk profile.

• In April 2018, Mithra announced the first positive results of this Phase II study of Donesta®. The results showed that 15mg E4 significantly reduces the frequency and severity of hot flushes, as well as secondary menopausal symptoms such as vulvo-vaginal atrophy (VVA), while confirming a promising safety profile. Based on these positive results, Mithra applied for an additional patent to further strengthen and extend the existing Donesta® intellectual property estate.
• In June 2018, Mithra presented the Phase IIb study results for Donesta® at the 16^th World Congress on Menopause in Vancouver, Canada (these results were also presented at the North American Menopause Society in October 2018). These data reinforced the previously announced positive Phase IIb study results and also demonstrated an encouraging cardiovascular safety profile and lower bone turnover versus placebo^[11]. The promising safety profile at both haemostatic and metabolic levels is consistent with the findings obtained during Phase II of Estelle® contraceptive.
• These promising results move Mithra's blockbuster potential to the next stage of clinical development: the Donesta® Phase III study, a worldwide randomized, multicenter, double-blind, partial, placebo-controlled, multicenter Phase III trial. This study will evaluate the efficacy and safety of E4 for the treatment of moderate to severe vasomotor symptoms in postmenopausal women. The start of patient recruitment for this phase III with E4 monotherapy is planned for the second half of 2019 pending approvals, with a marketing authorization expected as early as 2023. The global menopause market currently stands at USD 8.6 billion and is expected to grow to approximately USD 16 billion by 2025^[12].

PeriNesta® – the candidate treatment for perimenopause (15 mg E4/3 mg DRSP + vitamin) - About to start Phase III study

Post-period end, Mithra announced the expansion of its E4 development program with a third product candidate, PeriNesta™, for the underserved perimenopausal market. This affects women between late reproductive and menopausal age. PeriNesta™ ((E4 15 mg/DRSP 3 mg/Vit) has the potential to be the first product on the market to meet the needs of women during this life phase. It would offer women experiencing perimenopause an improved benefit-risk contraceptive solution and address the first menopausal symptoms.

This third E4-based product candidate will be the subject of a limited safety study with a comparable formulation to E4 15mg/DRSP 3 mg in women aged around 50 years with vasomotor symptoms. The cost of the study will be low thanks to the extensive clinical data available. Mithra has also filed an additional patent application based on the existing data generated in previous clinical studies. This patent would strengthen and extend the E4 intellectual property estate for menopause and perimenopause until 2039.

This new blockbuster potential represents a significant new business opportunity while requiring limited additional investment. This addressable and underserved market is estimated up to 35 million patients each year in the U.S. and three major European markets[13]. This represents a multi billion EUR market value with no existing approved product on the market addressing the dual need of contraception and hot flushes relief and other menopausal symptoms during perimenopause. Pending regulatory agency approvals, Mithra should be in a position to target market authorizations in 2023.

2. Portofolio of complex therapeutic solutions

Myring™ - hormonal contraceptive vaginal ring made of ethylene vinyl acetate copolymers (EVA)

To date, Mithra has licensed Myring™ to industry leaders in eight international markets, including the United States, Austria, the Czech Republic, Russia, Denmark, Chile, MENA region, Australia and New Zealand. All contracts provide for the production of vaginal contraceptives at the Mithra CDMO facility in Belgium, which has tripled its production capacity to meet orders placed and the expected market increase.

• In March 2018, Mithra announced it had granted an exclusive license and supply agreement to Alvogen for the commercialization of Myring™ in Russia, a market worth approximately EUR 13 million^[14].
• Also In March, Mithra announced that the Abbreviated New Drug Application (ANDA) for its vaginal contraceptive ring, Myring™, had been accepted for filing by the U.S. Food and Drug Administration (FDA). The ANDA was submitted by Mithra’s partner for the U.S. commercialization of the vaginal ring, Mayne Pharma (ASX:MYX). For this contract, Mithra received a EUR 2.4 million down payment and is eligible to receive further milestones of at least EUR 7.6 million from approval by the U.S. FDA through to commercial launch of the product. Following the FDA's request in December 2018, new test batches will be produced at the Mithra CDMO facility in Belgium during the first half of 2019. According to the latest commercial information, Mayne Pharma is still one of the best positioned players to launch the first generic version of Merck's NuvaRing® in the U.S. market, which represents over 75% of NuvaRing®'s annual global revenues[15].
• In June 2018, Mithra announced an exclusive license and supply agreement with Orifarm for the commercialization of Myring™ in Denmark, a market worth approximately EUR 0.75 million^[16].
• In July 2018, Mithra received its first Marketing Authorization (MA) for Myring™ in the United Kingdom, following approval by the MHRA (Medicines and Healthcare Products Regulatory Agency). The UK market is worth approximately EUR 1.2 million^[17] with no generic competition on the market yet. Under the same decentralized procedure, MAs for seven other countries (Latvia, Hungary, Croatia, the Czech Republic, Poland, Slovakia and Slovenia) were also granted.
• In September 2018, an exclusive license and supply agreement for the commercialization of Myring™ in Chile was signed with Laboratorio Pasteur. The Chilean market for contraceptive rings accounts for €5.8 million and is fast-growing, with an 18% increase between 2016 and 2017[18].
• In November 2018, Mithra signed an exclusive license and supply agreement with Neo Health for Myring™ in Australia and New Zealand. An important area where the contraceptive market represents about 107 million euros with a growing demand for products such as the vaginal contraceptive ring[19].
• Post-period end, Mithra signed an exclusive license and supply agreement with ITROM for Myring™ in MENA region, where the hormonal contraceptive market is estimated at EUR 37.5 million[20].

Tibelia® – generic version of tibolone (Livial®) for use in Hormone Therapy (HT)

To date, Mithra has granted about ten Tibelia® licenses.

• In July 2018, Mithra signed an exclusive license and supply agreement with Mediner for the commercialization of Tibelia® in Hungary, a market worth approximately EUR 0.6 million[21].
• In September 2018, Mithra and Pei Li Pharm entered into an exclusive licensing and supply agreement for the commercialization of Tibelia® in Taiwan, which has a menopause market worth approximately EUR 4.1 million[22].
• In December 2018, Mithra signed a licensing agreement with UAE-based company ITROM for Tibelia® and Daphne Continu (contraceptive pill 21 +7). Combined, the products will generate at least €8 million of value for Mithra. ITROM will distribute the products in the Middle East and North Africa region (Saudi Arabia, United Arab Emirates, Bahrain, Kuwait, Qatar, Sultanate of Oman, Lebanon and Jordan). The hormonal contraceptive market in the MENA region represented a potential of EUR 37.5 million in 2017, while the overall hormonal menopause market was worth EUR 2.65 million[23].

Zoreline® – generic version of goserelin (Zoladex®) for prostate & breast cancer and benign gynecological conditions – subcutaneous implant 1&3 month

• In February 2018, Mithra received positive results of its one-month pilot pharmacokinetic (PK) and pharmacodynamic (PD) study for Zoreline®. The safety profile of the 1-month implant (3.6 mg) is similar to the branded Zoladex® implant (AstraZeneca) and therefore meets regulatory requirements.
• In December 2018, Mithra announced positive results for the three-month formulation of Zoreline®, enabling it to initiate the final clinical studies. The pivotal studies on 3-month and 1-month formulations are intended to take place in the first and second half of 2019, respectively.
• Following the results of these studies, Mithra plans to file for marketing authorization via partners. Zoreline® represents a significant business opportunity, with total sales of Zoladex® worldwide of USD 693 million in 2017[24]. No generic version of Zoladex® has been approved to date, except for a few Eastern European countries. The one-month implant accounts for over 55% of the sales volume[25].

Sterile Injectables

In May 2018, Mithra announced it had closed a contract with Midas Pharma for the development of a sterile injectable product at Mithra’s CDMO in Belgium.

3. Mithra CDMO 
4. Mithra CDMO, Mithra’s Research, Development and Manufacturing Platform strengthened its environmental policy in 2018 with the creation of an internal committee aiming to implement various measures to reduce its environmental footprint. With the installation of 1800 solar panels, the Mithra CDMO is aiming to secure approximately 50% of its electricity consumption through a renewable energy source. This green source allows Mithra to reduce its carbon footprint and reduce a major cost driver. Opened in 2016, Mithra’s technological platform incorporates strict environmental considerations in terms of air treatment, containment measures, modern solutions for energy monitoring and choice of reusable consumables.
5. In December 2018, Mithra CDMO acquired new manufacturing equipment to triple its production capacity. The upgraded equipment will be used to sustain commercial demand thanks to commercial agreements and expected market increase.
6. Post-period end, Mithra CDMO started the commercial manufacturing process of the vaginal contraceptive ring Myring™ with a first batch for the European market (Czech Republic). The Mithra CDMO development and production center plans to start manufacturing further commercial batches for the European market (Austria, Denmark, Belgium, Luxembourg and the Netherlands) in the second half of 2019, as scheduled.
7. Post-period end, Mithra announced it signed a contract with CEVA Animal Health, leading global veterinary pharmaceutical group. With this first veterinarian project in development, Mithra will develop a hormonal device for the fertility market. This new polymer-based device would be a real innovation and bring an additional competitive edge to our partner while expanding Mithra’s polymer based technology expertise

4. Belgium and Luxembourg Business

In July 2018, Mithra announced that it had signed a comprehensive partnership in Belgium and Luxembourg worth up to EUR 40 million with Ceres Pharma, a Belgian-based company focused on over-the-counter (OTC) and specialist healthcare. The agreement covers the sale of the women’s health branded generics business in Belgium and Luxembourg as well as non-exclusive license and supply agreements for a number of Mithra’s products and product candidates developed in-house, including licenses for the commercialization in Belgium and Luxembourg of Tibelia®, Myring™ and Estelle®.

For Mithra, the sale of the branded generics business realized the value of the divestment of a non-core asset, as the Company continues to become an innovative biopharma company fully-focused on its innovative E4 based asset portfolio and its Complex Therapeutics development know-how. Following the successful private placement in May 2018, the cash inflow realized through the agreement with Ceres Pharma will further strengthen Mithra’s financial position and investments in its potential blockbusters.

5. Outlook

Building on the progress made in 2018, Mithra is looking forward to continued progress in 2019, which will further strengthen its position as a leading innovative international Women’s Health company.

Following the positive top-line Phase III results for Estelle® in Europe/Russia and U.S./Canada, Mithra is entering the final stages of clinical development for its oral combined contraceptive candidate and intends to file for market authorization in Europe and the U.S. by the end of 2019. Mithra will also continue its partnering discussions for the exclusive license and commercialization rights in the U.S., as well as in other key international markets.

Mithra will also continue to prepare for Phase III studies of Donesta® and PeriNesta™, its second and third potential blockbuster candidates, which could begin in H2 2019. With a strong cash position, a backlog of contracts with regulatory milestones to be collected in the near term, and a very promising out-licensing activity, Mithra is able to fund both trials and complete the development of both the perimenopause and menopause programs itself. Depending on regulatory approvals, Mithra believes it could achieve marketing authorization for both candidates in 2023. Ongoing patent applications would protect Donesta® and PeriNesta™ intellectual property rights until 2039. Furthermore, Mithra remains focused on establishing the best commercial partnerships for these product candidates and to further accelerate commercial licensing agreements in menopause and in perimenopause in the U.S. and in the main European markets.

Mithra also continues to explore further additional indications for E4, in particular in pediatric neuroprotection, to treat hypoxic ischemic encephalopathy (HIE).

The Mithra CDMO in Belgium will reinforce the Company’s R&D and commercial production activities. With state-of-the-art equipment and know how, the company is preparing to triple its production capacity to deliver the next commercial batches of Mithra’s vaginal ring Myring™ during H2 2019. Mithra also anticipates that its U.S.-partner Mayne Pharma should receive FDA approval for the commercialization of Myring™ in the U.S. from 2020. In terms of R&D, Mithra will launch pivotal studies for Zoreline^® in 2019 as well as undertake additional research projects.

In 2019 and beyond, we expect further significant revenue growth based on the potential for further E4 partnerships in the U.S. and other international markets.

For more information, please contact:

Alexandra Deschner (IRO) : +32 490 58 35 23 - investorrelations@mithra.com

Maud Vanderthommen (Press) : +32 473 58 61 04 – press@mithra.com

Consilium Strategic Communications

Susan Stuart, Olivia Manser, Melissa Gardiner

mithra@consilium-comms.com

+44 2 037 095 700

Financial Calendar

• 8 April 2019 : Annual Report 2018
• 16 May 2019 : Annual General Shareholders Meeting
• 19 September 2019 : Interim Report 2019

About Mithra

Mithra (Euronext: MITRA) is dedicated to providing innovation and choice in Women’s Health, with a particular focus on contraception and menopause. Mithra’s goal is to develop new and improved products that meet women’s needs for better safety and convenience. Its three lead development candidates – a fifth generation oral contraceptive Estelle® and next-generation hormone therapy Donesta® - are built on Mithra’s unique native estrogen platform, E4 (Estetrol). Mithra also develops, manufactures and markets complex therapeutics and offers partners a complete spectrum of research, development and specialist manufacturing at its CDMO. Mithra was founded in 1999 as a spin-off from the University of Liège by Mr. François Fornieri and Prof. Dr. Jean-Michel Foidart. Mithra is headquartered in Liège, Belgium. Further information can be found at: www.mithra.com

Important Information

The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The Company's actual results may differ materially from those predicted by the forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.