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Post by notamnkdmillionaire on Aug 5, 2014 16:56:42 GMT -5
Amphastar Pharmaceuticals, Inc., headquartered in Rancho Cucamonga, California, established in 1996, is a recognized specialty pharmaceutical company that uses state-of-the-art, cGMP compliant facilities to develop, manufacture, and market injectable and inhalation products. In addition to the Corporate Headquarters, Amphastar has five manufacturing facilities located in the United States, China and Europe along with a state-of-the-art New Drug Research Center. Amphastar and its subsidiaries each have their own distinct focus that they skillfully bring together to meet the varied needs of the pharmaceutical industry. We currently produce approximately 15 injectable products while we continue to develop a portfolio of generic and branded products that target large markets with high technical barriers to entry. Amphastar’s long-standing relationship with the major group purchasing organizations and drug wholesalers in the U.S. enables it to establish significant market share upon the introduction of its new products. Amphastar France: Amphastar France Pharmaceuticals Amphastar France Pharmaceuticals S.A.S. (Amphastar France) is a French corporation with its manufacturing facility located in Eragny-sur-Epte, France. Amphastar France manufactures and sells recombinant human insulin (RHI) API and porcine insulin API. RHI API manufacturing involves multiple stages of conversion of raw material to the active ingredient form. A portion of the facility is dedicated for the manufacturing process of the porcine insulin API. The facility performs all operation of porcine insulin API from raw material processing to delivery. As with Amphastar’s other subsidiaries, Amphastar France is focused on continuous production quality as well as quality working conditions. Amphastar France’s facility is regularly inspected by the FDA and the National Security Agency for Medicines and Health Products (ANSM), and the facility has a good standing regulatory/cGMP compliance record. Amphastar intends to continue to leverage the Amphastar France site in connection with its industrial and commercial strategy. The facility and other assets owned by Amphastar France were acquired in April 2014 from one of Merck Sharpe & Dohme’s businesses (Diosynth France). See more here: www.amphastar.com/index.html |
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Post by chauffe00 on Aug 5, 2014 16:58:18 GMT -5
Great stuff thanks!!!
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Post by notamnkdmillionaire on Aug 5, 2014 17:06:38 GMT -5
More:
Going Forward
CEO Message
Executive Management
Board of Directors
Going Forward
Amphastar’s “Vision for the Future” is to be an industry leader in the development, manufacture, and marketing of injectable and inhalation pharmaceutical products. We will continue to manufacture and distribute high quality products in an efficient manner so that we can offer them to the consumer at competitive, yet affordable prices.
Clearly understanding what it will take to achieve this vision, Amphastar will remain vigilant in its investment in new R&D, the expansion of its current injectables and inhalation lines, and making improvements to its delivery systems and dosage forms for existing products.
In the area of new products, we will target better drugs for the diseases that plague our aging population such as Alzheimer disease, cancers, asthma, diabetes and osteoporosis.
Amphastar intends to continue to invest in its people by providing educational opportunities for advanced degrees and individual skills training to ensure that the highest standards in quality pharmaceutical manufacturing and technology are not just met but exceeded.
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Post by jake10977 on Aug 5, 2014 17:12:15 GMT -5
AMPH has a market cap of 380 million. I think we head down tomorrow until we get more answers.
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Post by mnholdem on Aug 5, 2014 17:21:52 GMT -5
In addition to the Corporate Headquarters, Amphastar has five manufacturing facilities located in the United States, China and Europe along with a state-of-the-art New Drug Research Center. So this still leaves open the slight possibility of my pick of Eli Lilly (USA) as the manufacturing partner for Afrezza, although I had selected them because they also manufacture human insulin in Indianapolis. It's possible Amphaster has been selected to be a secondary supplier, and their insulin will supply European and Chinese manufacturing facilities to hold down costs.
I guess we'll all find out on the 11th.
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Post by kc on Aug 5, 2014 17:42:24 GMT -5
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Post by kc on Aug 5, 2014 17:54:22 GMT -5
I think this has a lot to do with China too? Maybe not but the company seems to have some growth idea's there. Not sure what the approval process is for the Chinese market but the two SR. officers of the company seem to possibly be from China.
Jack Yongfeng Zhang, Ph.D.
67 Chief Executive Officer, Chief Science Officer and Director
Mary Ziping Luo, Ph.D.
64 Chief Operating Officer, Chief Scientist and Chairman of the Board of Directors
Investment in China
We entered into agreements with a Chinese governmental entity to acquire land-use rights to real property in Nanjing, China. Under the terms of these agreements, we are obligated to invest capital in our wholly-owned subsidiary, Amphastar Nanjing Pharmaceuticals Co., Ltd., or ANP, and to develop these properties as a manufacturing facility. In conjunction with these agreements, ANP modified its business license on July 3, 2012 to increase its authorized capital. As of March 31, 2014, we have invested approximately $37.8 million in ANP of its registered capital commitment of $61.0 million. We are obligated to invest an additional $23.2 million in ANP, which is due by September 2014. This requirement to invest in China will result in cash being transferred from Amphastar to ANP.
Per these agreements, in January 2010 we acquired certain land-use rights with a carrying value of $1.2 million. In addition, we purchased additional land-use rights in November 2012 for $1.3 million. We are committed to spend approximately $15.0 million in land development. The agreements require the construction of fixed assets on the property and specified a timetable for the construction of these fixed assets. The current pace of development of the property is behind the schedule described in the purchase agreement and, per the purchase agreement, potential monetary penalties could result if the development is delayed or not completed in accordance with the guidelines stated in the purchase agreements. We are currently engaged in ongoing discussions with the Chinese governmental entity regarding the investment and the development of the properties. We believe that the Chinese governmental entity will accept our development plans for ANP.
Anticipated Liquidity
We expect our cash requirements to increase significantly in the foreseeable future as we move forward with our product candidates, pursue strategic acquisitions of businesses or assets and as we sponsor clinical trials for, seek regulatory approvals of, and develop, manufacture and market our current development-stage product candidates.
We expect that cash flows from ongoing operations borrowing capacity under our existing lines of credit will enable us to meet our obligations as they become due in the next 12 months and in the foreseeable future, including scheduled debt and lease payments. We expect additional cash flows to be generated in the longer term from future product introductions, although there can be no assurance as to the regulatory approval for any product candidates we are developing or the timing of any product introductions, which could be lengthy.
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Post by joeypotsandpans on Aug 5, 2014 17:56:14 GMT -5
was going to add that Piper Jaffray was a co underwriter for their offering...wonder what our "friend" (hint of sarcasm) will think about it, although on his list of coverages includes MNKD...AMPH is not there.
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Post by joeypotsandpans on Aug 5, 2014 17:57:16 GMT -5
was going to add that Piper Jaffray was a co underwriter for their offering...wonder what our "friend" (hint of sarcasm) will think about it, although on his list of coverages includes MNKD...AMPH is not there. friend referring to Joshua Schimmer of course |
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Post by kc on Aug 5, 2014 18:36:21 GMT -5
Notice that Jefferies was involved too.
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Post by kc on Aug 5, 2014 19:27:34 GMT -5
Perhaps another take on Amphastar.
old article from September 2013. But my point for posting is this paragraph regarding approval in other countries. Especially the EU where drugs have to pass the EMA.
blog.pharmexec.com/2013/09/18/ever-bullish-al-mann-says-afrezza-is-coming-in-mid-april/
Al Mann was less ambiguous, in a phone conversation with PharmExec. “I would expect it to be approved in mid-April [2014],” says Mann. “On our schedule it looks like April 14, but it could be a few days before or after.” Mann says his company will file in Europe shortly after completing the US submission. Mann says other markets are looking to the FDA and EMA as a guide on this product; however, “a number of countries are talking about approving [Afrezza] simultaneously…and one country is even talking about doing it before the US.” Which country is that? Mann wouldn’t say.
So you have to wonder what is really going on as perhaps we are closer to EU approval and the signed purchase agreement for Insulin from (July 31, 2014) Amphastar France Pharmaceuticals S.A.S., a French corporation will help it win approval more timely with the EMA since its an approved EU production facility?
Any thoughts on this?
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Post by kc on Aug 6, 2014 17:03:36 GMT -5
Can you say Merck?
www.sec.gov/Archives/edgar/data/1297184/000104746914005043/a2219389zex-10_18.htm
Read the sale agreement MRK had with Amphastar. Deal consumated in April 30 2014. but payment due in December 2014? was this in anticipation of the approval of Afrezza and that MRK wanted to have an arms length arrangement to divest of the plant to meet sometype of Antitrust regulations in EU for controlling too much of the Diabetes market or Insulin market?. Something is burning here.
Page 14:
(b) On December 21, 2014, Buyer shall pay to Seller the balance between the Final Purchase Price and the First Installment by wire transfer of immediately available funds in accordance with wire instructions delivered by Seller to Buyer at least two Business Days prior to December 22, 2014
ASSET PURCHASE AGREEMENT
(LONG FORM)
AMONG
DIOSYNTH FRANCE
(AS SELLER)
AMPHASTAR FRANCE PHARMACEUTICALS SAS
(AS BUYER)
AND
SCHERING-PLOUGH
April 30, 2014
It makes you wonder if there is a reason why Merck sold the plant on April 30, 2014 in anticipation of buying Mannkind. The buyer of the plant was an established company but was not public. They had their IPO in June 2014.
Seems like transactions happening to make way for a potential deal with MannKind. Is it a coincidence that MannKind is going to buy Insulin from a former MRK plant?
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Post by BD on Aug 6, 2014 17:27:13 GMT -5
Found this while slumming on YMB: finance.yahoo.com/mbview/threadview/?&bn=0243242e-59fb-3abc-8d27-962c7bf26a1d&tid=1407360808437-f19c4c75-efd4-4319-9700-dbedd10ac10e&tls=la%2Cd%2C6%2C3Reply to query about Amphastar from MNKDI just wrote to MNKD to inquire about yesterday's SEC filing and some of the concerns it raised. I received the following reply from Mr. Pfeffer. I am sharing to quell a few rumors here. ***************************** "Let me tell me what I can. Amphastar owns the facility that manufactured all the insulin used in our clinical trials to date supporting the Afrezza product approval. That is the only insulin source that is currently approved for use in the product. We can, and indeed plan to, add additional insulin sources, but these must be approved by the FDA, which will require clinical study in support of an application. There can be no certainly of any particular timing by the FDA, or that they will approve such hypothetical insulin at all. So a prudent company, if they were thinking of launching a product and thought it had a good chance of success, would want to be sure they have an ample supply of insulin immediately usable. Note that this insulin has always been made in France. There has been no change. Finally, we would not enter into such an agreement unless we were confident that we would be able to use it and that we would be able to pay for it. Hope that helps." ***************************** |
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Post by kc on Aug 6, 2014 18:08:17 GMT -5
Peeling the Onion back some more: ir.amphastar.com/secfiling.cfm?filingid=1047469-14-5868&cik=To complement our internal growth and expertise, we have made several strategic acquisitions of companies, products and technologies. These acquisitions collectively have strengthened our core injectable and inhalation product technology infrastructure by providing additional manufacturing, marketing and research and development capabilities including the ability to manufacture raw materials, APIs and other components for our products. On April 30, 2014, we completed our acquisition of Merck Sharpe & Dohme's, or Merck's, API manufacturing business in Éragny-sur-Epte, France, which manufactures porcine insulin API and recombinant human insulin API. In order to facilitate the acquisition, we established a subsidiary in France, Amphastar France Pharmaceuticals SAS, or AFP. We will continue the current site activities, which consist of the manufacturing and sale of porcine insulin API and recombinant human insulin API. As part of the transaction, we have entered into various additional agreements, including various supply agreements, as well as the assignment and licensing of patents Merck was operating under at this facility. In addition, certain existing customer agreements have been assigned to AFP. |
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Post by kc on Aug 7, 2014 20:43:59 GMT -5
One will have to imagine what Monday brings. Do we get an announcement of a partnership? Do we sell Afrezza to a Pharma? Is that Pharma MRK? How does this now insulin supplier fit in? Who really owns AMPH? The newly IPO company who also reports their 2nd quarter earnings on Tues August 12 at 2:00 pm. Seems like a perfect storm or cliff hanger. Made for TV drama. Amphastar Pharmaceuticals to Release Second Quarter Earnings and Hold Conference Call on August 12, 2014 Amphastar Pharmaceuticals, Inc. Aug 5, 2014 8:30 PM GlobeNewswire RANCHO CUCAMONGA, Calif., Aug. 5, 2014 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (AMPH) announced that the Company will release results for its second quarter of 2014 ended June 30, 2014, after the market closes on Tuesday, August 12, 2014, and will hold a conference call to discuss its financial results at 2:00 p.m. Pacific Time. To access the conference call, dial toll free 877-881-2595, or 315-625-3083 for international callers, five minutes before the conference. The passcode for the conference call is 80867405. The call can also be accessed on the Investors page on the Company's website www.amphastar.com. Amphastar is a specialty pharmaceutical company that primarily develops, manufactures, markets, and sells generic and proprietary injectable and inhalation products, including products with high technical barriers to market entry. Most of the Company's products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. This press release contains forward-looking statements, including statements relating to Amphastar Pharmaceuticals. These statements are not historical facts but rather are based on Amphastar Pharmaceuticals' current expectations, estimates and projections regarding Amphastar Pharmaceuticals' business, operations and other similar or related factors. Words such as "may," "will," "could," "would," "should," "anticipate," "predict," "potential," "continue," "expects," "intends," "plans," "projects," "believes," "estimates," and other similar or related expressions are used to identify these forward-looking statements. These statements are only predictions and as such are not guarantees of future performance, and they involve risks, uncertainties, and assumptions that are difficult or impossible to predict. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described from time to time in Amphastar Pharmaceuticals' filings with the SEC. |
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