BIOMM SA—2Q17 Quarterly Information Report

[mango]

• Snippets from BIOMM SA 2Q17 Quarterly Information Report

Highlights of the period

Biomm continues to develop among its researchers the improvement of its technologies, making the production of therapeutic proteins more competitive, expanding the protection of their intellectual property in other countries and developing commercial relations, especially international, in order to allow the negotiation of the mentioned technologies . In this context, Biomm has updated the specifications of equipment critical to insulin production, worked on the development to optimize processes and projects through electronic simulations. Also in this same sense, studies were carried out to increase the alternatives of critical raw materials, either through the development of new suppliers or technological development in partnership with universities or companies.

In the period under review, the construction of the Nova Lima plant began the process of demobilization of the contractors involved in the construction of the plant, with the closing of construction contracts, closure and coverage, lining and divisions including the final commissioning tests for the delivery of the factory's utility areas and direct and indirect equipment of the production line.

In terms of development projects in progress, being:

(i) Insulin Project: in the stage of industrial escalation within a German Contract Manufacturing Organization, which aims to produce, from Biomm technology, lots of insulin for use in pre-clinical and clinical tests, being these tests are necessary to obtain the production and marketing license;

(ii) Glargina Project: in process of internal development in the laboratory of quality control in Nova Lima (MG), through process mapping and development of procedures.

On February 21, 2017, Portaria no. 551, of the Ministry of Health (Portaria) was published in the Official Gazette of the Union, through which the Company was indicated as one of the private entities to participate in the Partnership for Productive Development "PDP") of the demand for Human Insulin for the Unified Health System (SUS) in 2017. This means that the Company will be responsible for 50% of the demand for Insulin Humana in the scope of PDP, in partnership with Fundação Ezequiel Days - FUNED. On April 20, 2017, as expected, the Company resubmitted the PDP project of Insulina Humana by official letter, and awaited the return of validation by the Evaluation Committees of PDP's.


Business development

Biomm is constantly evaluating the expansion of its portfolio to other biological and biosimilar medicinal products.

Thus, on May 31, 2017, an exclusive agreement for the supply, distribution and sale of the Afrezza Inhalation Powder ("Afrezza") product was entered into with MannKind Corporation. The Company will be responsible for preparing and submitting the necessary documents for the regulatory approval of Afrezza in Brazil, including approval with ANVISA and, with regard to aspects pertinent to the pricing of the product, approval by the Market Regulation Chamber for Medicines (CMED). Once approved by both regulatory bodies, MannKind Corporation will produce and supply Afrezza to the Company, which will be responsible for supplying and distributing the product in Brazil. This partnership could leverage its current portfolio of diabetes products, offering a new option to improve the quality of life for those with the disease.

On June 29, 2017, the Company's Board of Directors approved the beginning of sales of the Confort Care product, in accordance with the agreement entered into with Affinitá Laboratory. Thus, from July 2017 the company started selling Confort Care, one of the first dermocosmetics in the market with only 3% urea and the first to use nanotechnology in hydration of the feet.


Deployment of the manufacturing unit - Continued

On February 20, 2017, Portaria no. 551, of the Ministry of Health ("Portaria") was published in the Official Gazette of the Union, through which the Company was appointed as one of the private entities to participate in the Partnership for Development Of the demand for Human Insulin for the Unified Health System (SUS) in 2017. This means that the Company will be responsible for 50% (fifty percent) of the demand for Insulin Humana within the scope of the PDP, in partnership with the Ezequiel Dias Foundation (FUNED). After the presentation of the project, the approval will be conditioned to the evaluation of the Technical Evaluation Committee and, later, to the validation by the Deliberative Committee of the PDP's.

On May 31, 2017, MannKind Corporation entered into an exclusive agreement to supply, distribute and market the Afrezza Inhalation Powder ("Afrezza") product. The Company will be responsible for preparing and submitting the necessary documents for the regulatory approval of Afrezza (inhaled insulin) in Brazil, including the approval with ANVISA and, with regard to aspects pertinent to product pricing, approval by the Market for Medicines (CMED). Once approved by both regulatory bodies, MannKind Corporation will produce and supply Afrezza to the Company, which will be responsible for supplying and distributing the product in Brazil.


3. The activities carried out within the scope of the Audit Committee attributions, in the period:

The Audit Committee met on 08/08/2017 and this meeting evaluated the changes in the accounting numbers for the quarter ended June 30, 2017.

The Company's representatives presented the highlights of the period of June 30, 2017: (i) development of the plant in Nova Lima, (ii) conclusion of the capital increase, (iii) partnership with Laboratory Affinita to resell the Confort Care product from July 2017, (iv) partnership with MannKind Corporation an exclusivity agreement for distribution of the Afrezza product and (v) information on the Gabas project.


ir.biomm.com/default_download.asp?NArquivo=ITR_30_06_17_enviado11_08_17.pdf&arquivo=4B84A353-1FD9-4BCF-8F55-A89BFE045401

[Deleted]

According to Castagna during the radio interview filing will be within a week or two!

[Deleted]

I am anticipating an announcement any day.

[itellthefuture777]

Oct 16, 2017 10:56:04 GMT -5 @kastanes said:

According to Castagna during the radio interview filing will be within a week or two!

Correct..and he said that almost 2 weeks ago..now...hmm

[Omega]

Oct 20, 2017 11:26:17 GMT -5 itellthefuture777 said:

Oct 16, 2017 10:56:04 GMT -5 @kastanes said:

According to Castagna during the radio interview filing will be within a week or two!

Correct..and he said that almost 2 weeks ago..now...hmm

8 days ago (10/12/2017)

[nadathing]

Am I mistaken, or did they say they did not expect approval and possible shipments to Brazil until late 2018? Thanks.

[dreamboatcruise]

Oct 20, 2017 16:31:45 GMT -5 nadathing said:

Am I mistaken, or did they say they did not expect approval and possible shipments to Brazil until late 2018? Thanks.

That's what I remember.

[agedhippie]

Oct 20, 2017 18:25:14 GMT -5 dreamboatcruise said:

Oct 20, 2017 16:31:45 GMT -5 nadathing said:

Am I mistaken, or did they say they did not expect approval and possible shipments to Brazil until late 2018? Thanks.

That's what I remember.

That would not be inconsistent with the likely timeline. If you look in the same filing that was cited you see that BIOMM filed for approval on a Regular insulin produced in Poland and manufactured in a plant that was already approved. That filing was made in January so we are at 9 months and counting. If a filing happens for Afrezza next week it will still likely to be Q3 2018 before it's approved and shipping starts.

[brotherm1]

I’m good with that

[agedhippie]

Oct 20, 2017 19:51:06 GMT -5 brotherm1 said:

I’m good with that

Me too. I wish they would file in Europe as well. It may not be an immediate target but you can always slow walk the application and then when you really want to move forward at least you are part way though the process. That might not be a bad model to follow in other markets.

[mnholdem]

I think that EMA requirements which follow an application for marketing approval in Europe may be simply be too expensive for MannKind at this time. The EMA doesn't often accept FDA approval data as sufficient.

[ghochr]

Once filed does any one know how much time they take to approve?
Filing probably is big win by itself considering all that has happened in the last three years that Afrezza has been approved

[liane]

210 + 67 days:

www.nature.com/nrd/journal/v7/n11/fig_tab/nrd2728_F1.html

[lakers]

Oct 21, 2017 10:08:47 GMT -5 mnholdem said:

I think that EMA requirements which follow an application for marketing approval in Europe may be simply be too expensive for MannKind at this time. The EMA doesn't often accept FDA approval data as sufficient.

That's correct. Note that the 2 studies conducted by Sny for the new label were conducted soly in Germany for a reason.

Canada, Mexico are gimme with NAFTA stamped on their foreheads, OUTSULIN, A trademarked, new label, ready to go.

Mnkd's strategy near term is targeting populous countries which accept FDA results. This helps address the plant fix cost which can support $2B sale.

A: We continue to update on our international expansion at every opportunity as it represents a means of expanding Afrezza sales, one of two top priorities expressed by both Mike and Steve, the other being recapitalization. As Mike stated in August, we are still on track to file by the end of the year in Brazil, if not sooner. As you may surmise, with the recent approved label update, our partner, BIOMM, wanted to reflect the FDA's approval in its filing with ANVISA. The timelines with respect to other international opportunities vary based on regulatory requirements in each country and potential partnership discussions always seem to take longer than originally anticipated. We are currently targeting Canada, Mexico, India and China in the near term and, as you know, after following MNKD all these years, we would not make any announcements until there is a definitive partnership agreement in place. UAE has always been an area which Al felt passionate about. We continue to work with international regulatory experts to prioritize our expansion.

Read more: mnkd.proboards.com/user/1882/recent#ixzz4wAZCwGQm

International expansion is another opportunity. So we announced BIOMM in Brazil. That deal is moving forward. We have several other markets that are of interest to us that we’ll continue to work on. Those markets are important because of the volume. When you see the plant that we build, it was built to do over $2 billion in sales and $6 billion in cartridges a year. So that’s a fixed cost. Most companies of our size don’t always have that big of a plant ready to go, but this company was meant to be a multi-billion dollar company. And the part of it was meant to take off a little bit faster. But obviously, that didn’t happen so we’ve been readjusting our cost structure.

But the international expansion will consume a lot of the volume of insulin in terms of just getting rid of some of the purchase commitments we have with [Indiscernible]. And as you think about the U.S., we’ll get a decent amount of volume here as well. But if you look at cost of pharmaceutical industry, whether we like it or not, the U.S. market is where most companies make their profit and get their growth. And so that’s our major focus and we’ll be opportunistic around some of the other international markets in terms of do we want them for MannKind or do we partner those out, and that’s something that we continue to work through.

Read more: mnkd.proboards.com/user/1882/recent#ixzz4wAaGZbFe

[patten1962]

Pardon my ignorance. Can someone give me a time frame Of when we might start selling overseas? I know it's hard to say not being on the inside but what is your best guess? Wanna see a purchase order!